I wanted to start a new thread specifically for this (and guys that have questions about it). The other Xiaflex thread is 5 pages and has a lot of different topics going on. I ended up qualifying for the trial because the hourglassing is gone and I am still over 30 degrees of curve. The calcifications were very minor - though the plaque feels like bone - so i was concerned but the ultrasound showed very little dots of calcium that are not significant.
Anyway, I am 99% sure I got the placebo... nothing happened at all that is remotely close to what happened in the Xiaflex / Duputreyn's study. However, I want to ask others if anything happened with them (either Phase 2 people who had the real drug or other Phase 3 people). I put details from the Duputreyn's study below. I really don't want to go through this for 13 months for nothing. I can't even use fast size or take oral meds for 13 months to comply with the study. I'm not sure I care that I'll be the first to get the "real drug" in the end - if I give up a year of my life to Auxillium when the traction device just started working a month ago.
But have any guys who have been in this trial had the reactions below? Has anyone improved who was NOT on the placebo in phase 2 - or in phase 3?
All adverse reactions 98% vs. 51%
Peripheral Edema (swelling) 73% vs 5% Placebo
Contusion (bruise) 70% vs 3% Placebo (will be higher in the penis than the hand - regardless of what was injected)
Injection Site Hemorrhage 38% vs. 3% Placebo
Injection Site Swelling 24% vs. 6% placebo
Lymphadenopathy (swollen lymph nodes) 13% vs. 0% placebo
https://www.xiaflex.com/docs/pi_medguide_combo.pdf
Also notice Xiaflex patients all have swelling:
Dupuytren › Xiaflex injection | Forum for Dupuytren's contracture (http://www.dupuytren-online.info/Forum_English/board/dupuytren/xiaflex-injection-0_926.html)
As I said in the other thread, I've had two injections and so far no swelling or reaction of any kind. I haven't started the modeling yet though and I heard that is when you may see more of the swelling. Not sure why...
My nurse thinks I may be getting the drug because of the difference she noticed in drawing it up in the syringe. She said both times she drew it up, it was harder to pull back and it has a slightly different consistency in the vial. Of course she said she wasn't supposed to say anything and she doesn't want me to get my hopes up too much in case it is the placebo. I saw the vial and the liquid had a slight gel look to it whereas she said the other vials were more like water. Of course time will tell whether I got the drug. I don't want to continue in the trial if I think it's the placebo, but they say I will get the drug as long as I complete the full study. I guess I'll just bite the bullet even if it isn't the drug and just go the whole way so I can get it in the end. Damn, it's a lot of needle sticks for nothing!
Quote from: Chopsuey on December 04, 2010, 12:48:02 PM
Damn, it's a lot of needle sticks for nothing!
Yeah, for sure... and I really just started seeing results with Fastsize & some oral meds so I'd hate to stop all that for a year. That's my concern too - and it is very inconvenient to get to the study center in my case (not like the other guy in phase 2 who flew there though!). I can't stand the induced erections either - which they have to do to see your progress. I've gotten over the awkwardness by now (as much as I can)... but it burns & then creates an ache that doesn't go away for a while.
I'll look at the syringe and see if it's more gel like... interesting observation. Who knows though - the gel could be the placebo. It might be hard to make a placebo that is also freeze dried that looks exactly like xiaflex. I wonder what it even is... just saline? They said they actually can't say what it is (if they even know).
I had a morning erection after the night after the injection and it didn't hurt or anything. I don't know what to make of that (I never even have morning erections - and they should certainly hurt after a penile injection!). The doc did tell me straight out "you'll be pretty bruised - so just be prepared" - but there's nothing there... He also said my plaque was very thick and it was easy to get a "good injection" so maybe i'm less bruised since the needle hit fewer capillaries. I suppose bruising is from the needle pass, not the drug...? I wonder why there was so much more bruising with the xiaflex in dupuytren's contracture.
thanks for sharing your observations on the trials guys - Mike, I have been reading your different posts and thoughts on the study itself - I can appreciate that no one wants a series of pointless injections (placebo) into an already damaged old man ... but that is what you signed up for and presumably you knew the risks when you signed up ... Living in the UK, I can't help but feel very envious that you guys have access to a these trials - if this drug is signed off, it could be 2014-15 before it is distributed in Europe (still not available for dupuytrens over here yet) ... a year passes by in a shot (excuse the pun) so I think you should try be a little more positive bearing in mind you will be able to get the real drug either way at the end of the trial - If you're that concerned, just use the fastsize anyway...?
good luck and thanks for sharing
Quote from: ronners on December 05, 2010, 07:13:38 AM
thanks for sharing your observations on the trials guys - Mike, I have been reading your different posts and thoughts on the study itself - I can appreciate that no one wants a series of pointless injections (placebo) into an already damaged old man ... but that is what you signed up for and presumably you knew the risks when you signed up ... Living in the UK, I can't help but feel very envious that you guys have access to a these trials - if this drug is signed off, it could be 2014-15 before it is distributed in Europe (still not available for dupuytrens over here yet) ... a year passes by in a shot (excuse the pun) so I think you should try be a little more positive bearing in mind you will be able to get the real drug either way at the end of the trial - If you're that concerned, just use the fastsize anyway...?
good luck and thanks for sharing
Yeah... well I don't know what the right answer is and I've had some arguments w/ friends of mine too (and doctors who are friends) since I started suspecting I had the placebo. It's not easy to deal with any of this...I've lost like 1/3rd of my dick size thanks to Peyronies Disease...which for me put me way below normal size since I was only average to start. Some of it was just barely starting to normalize and come back in the last few months - finally. So, now I have to stop all that. You cannot use fast size or take any of the pills while in the study. I would not even want to use fast size in case I am in the "real drug" group - and collagenase is doing its thing, dissolving the excess collagen & possibly gets into the tunica...and then while wearing fastsize I rip the tunica apart. Yikes. And who knows if / how collagenase would interact with pentox, etc... so I'm not taking that (and they tell you not to before starting the study).
If I lived in the UK, I'd use fast size (or one of the other extenders) and take pentox, and L-arginine, pyncogenol, viagra / cialis, L-acetyl-carnitine, and ubiquinol. It'll probably work just as good as xiaflex, which I think only had a 47% improvement rate in phase 2 anyway (i think this might be wrong but i cannot remember the number). It sounds like the hand disorder has had more success...in that situation, they are manually releasing a collagen cord from the joint that they weaken with xiaflex...and the finger is naturally in motion all the time...I'm not sure how well it'll work with Peyronies Disease. Plus, I think there is more going on than excess collagen production. What about all the elastin that was destroyed in the tunica by Peyronies Disease? That isn't coming back...right? There are a lot of things I have been getting skeptical about with xiaflex for Peyronies Disease.
Mike - It's not an easy condition (I hate calling it a 'disease) to live with but at the end of the day you are obviously doing all you can to try and overcome the issue so try not to get down on yourself ...
In respect to Dupuytrens, yes the weakened cord is effectively snapped the day after treatment manually (after a night of non-movement) - one thing I would say is that looking at pics of the open hand surgery for Dups, the cords that develop in the hand are very thick and tough looking (i.e. they look much more significant than penile plaques) - whilst dupuytrens and peyronie's are totally different conditions, the fact that Xiaflex degrades the dupuytrens cord to such an extent that it can be snapped the day after treatment makes me feel that there is potential for improvement in peyronie's plaques - will it cure the condition? I'm not sure due to the elastin issue - will it improve the condition? I hope so by removing or degrading the collagen aspect of the plaque ... My understanding is that Phase 2 was more about the safety aspect of the drug as opposed to the end result - Phase 3 is where the drug company attempts to demonstrate significant and plausible results -
point taken on the fastsize - although I think it's unlikely based on the claims that xiaflex only targets the unhealthy tissue - you're in a better position to make that call though ...
I'm 29 years of age and use viagra / cialis - the other drugs (pentox / l'arginine etc) are not really prescribed by urologists in the UK - reason? my urologist (who is one of the UK's Peyronie's specialists) has suggested that he doesn't feel any sizeable or reliable trials have been conducted to date in relation to their efficiency but noted that the Xiafle trial was the biggest and most followed yet - hmmm! long topic but effectively the only option really in the UK is to live with it and take PD5 inhibitors or to go down the surgery route ... I'll take the first option thanks ... if I was in your shoes I would see this trial out - don't spend time worrying about if it's the placebo or not - you've got more chance that it is xiaflex than it isn't (2:1 ratio) and you'll get the real drug if you stick it out either way - if the drug turns out to help and people have good experiences on this forum then I will be paying to come and have treatment in the US rather than wait ...
good luck and I will follow your progress with interest ...
Hi guys,
I hope I didn't come off as negative when I expressed worry about possibly getting the placebo. I am actually very excited and feel lucky to be in the study. It's the newest and hopefully most effective treatment option out there right now. My only point is, if I am getting the placebo right now, not only do I have to wait a year to get the actual drug, I have potentially many injections to go through before getting the drug. However, I am willing to do that if it means getting improvement in size and curvature. Like Mike said, I too have lost size and was probably only average to begin with. Not exactly Johnny Holmes if you know what I mean. I would have liked to have an extra inch or two before this and now I've lost some of what I had not to mention gaining a double curvature. Great for the sef esteem...
Anyway, I will keep posting throughout my experience and most likely I will be able to figure out if I am getting the drug or not over the next couple of months. No improvement...no drug. We'll see...
Hang in there.
I think a specific thread for xiaflex trial patients could be beneficial, assuming it can't hurt t he study I think we should def go ahead and create one. Would be nice to have some structure to it, like everyone involved list things like
Region of Country:
Number of injections:
Symptons:
Any noticed results to date:
Etc....
Comebackid
Saw my urologist today for my first modeling. He said the plaque definitely felt "softer" to him today. I hope that's a sign I'm actually getting the drug.
In response to the ComeBacKid.
- I'm from Maryland
- Two injections with the drug (I hope) so far.
- No pain, curve up and to the right 47 degrees
- Too soon for results, other than my doc saying the plaque "felt softer".
- Don't usually need any drugs to achieve an erection, although Viagra makes it even better.
I've completed the first two shots of Cycle 2. As with Cycle 1, the first injection went well. Several hours after the second shot my penis started swelling and turning dark red. Later on it was swollen about 100% and was red to dark red to purple. After 1-2 days the swelling was mostly gone.
Although I thought there was some slight improvement over the past six weeks, I didn't want to get my hopes up until I was measured. Well, the good news is there was about a 10 degree reduction. So, combining that with the swelling and bruising from the second injection of each cycle, I think it's safe to say I am probably receiving the study drug.
Humorous
Humorous: I really appreciate you taking the time to post the results of your participation in the study.... please keep the reports coming!
Sounds great Humorous! 10 degrees is a bonus for cycle 1. Did you notice a size change at all?
One other question...does your shot burn when you get it? Or, are you numb before anyway?
I'll let you guys know my update soon too. I never had bruising or redness so far... but there may have been curve changes - it's a little hard to say due to erection quality issues. I've heard that cycle 1 doesn't produce a ton of change for most guys. They can't put too much in each injection since the chemical is so strong. They use the same dose for dupuytren's (0.58 mg)... which lets the doc just snap the collagen cord the next day. Kind of crazy...and Xiaflex can't "tell the difference" between the bad and good collagen. It will dissolve it all - till the drug is used up by the cells (hence the penile fracture risk in the informed consent...and I think my doctor commented about it being harder to inject in plaques that are very thin). It's the same collagenase that dissolves your tissues during gangrene - so it doesn't discriminate against good collagen. There's an interesting story on the history of Xiaflex here...not sure if it's been posted to this forum yet. It's been 50+ years since it was isolated...hard to believe the lag time...! If Peyronies Disease was as prevalent as diabetes, we'd be on our 10th generation of xiaflex-like compounts (if you're interested in medical history - it's quite amazing what insulin went through in the last 100 years too - from the days when your mom would inject you (as a kid) at home with self-sharpened reusable needles!)
http://www.nytimes.com/2010/03/16/business/16hand.html (xiaflex history)
My Update after 2 Shots + Measurement at 6 weeks + 2 More shots (will update in when this last injection series has taken effect and i can have 100% erections again - they ask you not to for safety right after):
I would appreciate any thoughts (from all posters) on some of this - since there are conflicting things here.
- Curve went down but it's not easy to measure & is slightly worse on one side (sort of slanted - from the start though)... so there may be a little measurement error. It went down over 10 degrees per their notes. However, measurement difficulty & personal observation makes me think it is around 8-10 degrees - 6 weeks after series 1 injections.
- Plaque is unchanged in size (which makes it is odd how the curve went down)... and seems equally firm... though it may be softening on the border with the tunica...hard to know. Hard to explain curve changes with equal plauqe - but then again, it's hard to track what is going on with the plaque begins and ends also.
- Size is probably unchanged...again hard to tell - erection quality varies. I think I saw more size gains on traction than I have with this so far.
- Dent is unchanged. The dents used to be on both sides but went away with traction (and possibly some oral meds) a few months prior to the study while I was in a more active phase (9 mos or so post onset).
Injection
- Burns for 10 seconds (as it is being injected) and then little else happens. There are minor pains later on but maybe a 2 on a scale of 1-10. Injection appears to be more of a gel - not watery. (Don't know if placebo would burn like this)
- No major side effect so far (weird for actual drug - which makes me think it is placebo - but I did apparently have a curve reduction...so who knows.)
Concern:
- My "hinge effect" seems to be getting worse (maybe). I can bend my penis somewhat easily even when it is fully erect... this started from day 1 with Peyronies but if part of the hard plauqe is softening / dissolving, the existing tunica isn't repairing itself yet...making quite a hinge effect... I have to see how this plays out - i dont always notice it. If I am 100% (aka taking cialis) it's not as bad.
I just got called by my urologist to see if I was interested in being in the study. I go next week for the initial testing. From reading the study criteria, I think I will qualify.
I have a couple of questions for those who have already started. What is the modeling? Is it done in the flaccid state? Also, does the erection inducing injection hurt? How long does the erection last? Do you have to get another injection to reduce the erection?
Quote from: marktx on January 12, 2011, 06:23:05 PM
I just got called by my urologist to see if I was interested in being in the study. I go next week for the initial testing. From reading the study criteria, I think I will qualify.
I have a couple of questions for those who have already started. What is the modeling? Is it done in the flaccid state? Also, does the erection inducing injection hurt? How long does the erection last? Do you have to get another injection to reduce the erection?
Modeling is done in the flacid state. They stretch your penis for a few minutes - gently. There is no attempt to break any plaque or do anything uncomfortable. It takes place the day after your 2nd erection. Then you have to do it yourself at home for a few minutes day.
The injection to induce erections tends to burn for a few seconds. You can't feel the needle (it's very thin). I think they have the option of giving prostaglandin, papaverine, or trimix... I don't remember exactly. Some burn more than others and some take longer to work - or wear off ... I am not an expert on this but your doc will probably have a preference for 1 over another depending on how you respond in the screening visit so you should ask him about it. The erection can last from 15 minutes to several hours. A 4+ hour erection is bad for you - but also unusual - and probably only would happen if the dose was too high. In my case, the opposite happens... I get erect from the shot, but the erection starts to go away as soon as the doctor walks back in the office (they leave for 10-15 minutes until the medicine starts to work). So, your mind can actually affect an erection that was locally induced. Everyone's different with this though.
If you have an erection that is not showing any signs of going down, they will give you the shot to make it go away. But, usually they'll just give you time to let it go away on its own or not give you such a high dose to begin with. If you live nearby, you can probably go home and just go back if the erection won't go down. The nurse told me they prefer not to use the anti-erection injection because of its side effects.
Quote from: MikeSmith0 on January 12, 2011, 07:07:25 PM
Quote from: marktx on January 12, 2011, 06:23:05 PM
I just got called by my urologist to see if I was interested in being in the study. I go next week for the initial testing. From reading the study criteria, I think I will qualify.
I have a couple of questions for those who have already started. What is the modeling? Is it done in the flaccid state? Also, does the erection inducing injection hurt? How long does the erection last? Do you have to get another injection to reduce the erection?
Modeling is done in the flacid state. They stretch your penis for a few minutes - gently. There is no attempt to break any plaque or do anything uncomfortable. It takes place the day after your 2nd erection. Then you have to do it yourself at home for a few minutes day.
The injection to induce erections tends to burn for a few seconds. You can't feel the needle (it's very thin). I think they have the option of giving prostaglandin, papaverine, or trimix... I don't remember exactly. Some burn more than others and some take longer to work - or wear off ... I am not an expert on this but your doc will probably have a preference for 1 over another depending on how you respond in the screening visit so you should ask him about it. The erection can last from 15 minutes to several hours. A 4+ hour erection is bad for you - but also unusual - and probably only would happen if the dose was too high. In my case, the opposite happens... I get erect from the shot, but the erection starts to go away as soon as the doctor walks back in the office (they leave for 10-15 minutes until the medicine starts to work). So, your mind can actually affect an erection that was locally induced. Everyone's different with this though.
If you have an erection that is not showing any signs of going down, they will give you the shot to make it go away. But, usually they'll just give you time to let it go away on its own or not give you such a high dose to begin with. If you live nearby, you can probably go home and just go back if the erection won't go down. The nurse told me they prefer not to use the anti-erection injection because of its side effects.
Mike,
What does the 2nd erection mean, or why does it take place?
Also, are you told to have sexual relations during the study?
Thanks,
BSSS
Quote from: MikeSmith0 on January 10, 2011, 08:07:51 PM
Sounds great Humorous! 10 degrees is a bonus for cycle 1. Did you notice a size change at all?
One other question...does your shot burn when you get it? Or, are you numb before anyway?
Mike,
I haven't noticed a size change but if there is I think it would be slight. Congratulations on your 10 degree change also.
If you're referring to the Xiaflex shots, it is slightly painful (the burning sensation you mention) when the Dr actually injects the medicine. The second shot (on the second day) was more painful. However, concerning the papaverine injection, it's not bad at all. I barely feel it.
On the first visit I declined the anesthetic because it didn't seem logical to me to get an injection to prevent pain during a second injection. In other words, if the first shot is going to be painful, why opt for two shots?
Humorous
Quote from: BSSS on January 14, 2011, 12:58:06 AM
Mike,
What does the 2nd erection mean, or why does it take place?
Also, are you told to have sexual relations during the study?
Thanks,
BSSS
Sorry, that was a typo. I meant to write "the day after your 2nd
injection". There are 4 injection "cycles" in the study. Each cycle has 2 total xiaflex injections (1-3 days apart depending on any swelling that has to subside) and then modeling another 24 hrs later after injection 2. So, each cycle requires 3 visits (or 4 visits if they do your curve measurements on a separate day from the xiaflex injection - they have to induce an erection every cycle to see what the curve is doing & measure it...and then wait for it to go down - then inject xiaflex - so that might push the whole cycle to 4 visits).
You are supposed to refrain from sexual activity for 2 weeks after the first shot. I didn't really get into what "sexual activity" meant with the staff - so I just left things alone the first time. However, I still had erections in the morning. So, I couldn't help that & I don't think they thought that was an issue. It didn't hurt either.
I am not sure what the 2 week reasoning is because if the collagenase is going to make the penis vulnerable to injury for 2 weeks (if it dissolves the collagen)... how is that confined to 2 weeks? That would be permanent. So, maybe it has something to do with swelling or not letting the drug get out of where it was injected. An erection might spread the collagenase out I suppose...but it's probably done working after a day.
Humorous - thanks for letting me know. We might both be getting the real thing!
Videos of a woman going through Xiaflex injections for Dupuytren's contracture were posted on Youtube a few years ago. I just found them. I thought some of you might be interested:
http://www.youtube.com/watch?v=29RLwrkSWEc&NR=1
Her side effects were nothing like what I experienced (though I might be getting placebo)...and at the same dose, this really makes no sense. It appears that the collagenase dissolved a part of her skin (see the later video). Her swelling and bruising are really bad. I don't think anyone has reported anything like this in the penis... I don't understand how it is so radically different when it is the same chemical. I think there's a lot less margin for error in the penis yet the dose is the same and the injection is the same...as far as I know.
She also says that her DC returned in recent times, despite going through all that. I'm not sure what to make of this. I wonder if DC patients take pentox or if I'll be on that forever post-xiaflex & have to use a traction device for the next 30 years..
Mike - I think it's important to bear in mind that whilst they are related, the two conditions are in two totally different parts of the body - what follows with one does not necessarily follow with the other ...
It seems reasonable to assume that much of the swelling and bruising shown in the video is down to the manual manipulation that needs to occur with Dupuytrens after the injection in order to snap the chord - this is clearly quite a traumatic and painful event; other treatment videos suggest similar results ... it's quite normal to assume that the hand would swell and react after an event like this ... whilst you have detailed the modelling aspect of the peyronie's trials, this is quite clearly not on a par with the manual snapping of the chord that needs to take place after xiaflex treatment for dupuytrens ...
I think it's also more likely that repeated injections into the same area could cause the skin damage - the subject talks of bleeding in the video and this is more likely to be as a result of repeated injections into the same site as opposed to her skin being dissolved from the inside out ... either way, she seems very happy with the results ...
as you know the drug was only approved for dupuytrens last year - long term trials are not yet complete although it is thought that xiaflex will reduce but not eradicate recurrence
Hi everyone,
I just went through my second phase of injections last Thursday and Friday. The evaluation showed a 10 degree reduction in curvature...better than I expected. I have an indentation on the right side of my penis that seemed to get worse, so my uro is injecting closer to that area than previously. He seems to think there are positive changes happening. I hope so. When he injected me this time, it hurt even more than the first time. When he hits plaque, there is resistance so he has to push harder for it to go in, causing more pain. Overall tolerable, but no fun. I don't think there is any change in size, just some reduction in curvature. I'm looking forward to see what changes occur in this cycle.
Chopsuey,
It's great to hear your results from Cycle 2. Isn't it strangely coincidental that of the three of us that have reported so far (You, Mike Smith0 and I), each reported a 10 degree change from Cycle 1.
I thought there was at least one other guy in the Phase 3 trial reporting on his progress but after looking over the comments below I couldn't find him. Do you know of anyone else reporting here?
Was your penis bruised or swollen after the Cycle 1 or 2 injections? (Mine was but Mike's wasn't.) Thanks.
Humorous
Guys,
Also just interested to know if any of you in the study group noticed any change in the size or firmness of your plaque / scar tissue??
Thanks for your efforts so far in posting ...
Goodmorning everyone,I have not posted here in a long time but read often.I am going in Wednesday for my blood test,EKG,Measurements,etc.etc. I am one of the people that has gone through the test and received the placebo.I will keep everyone posted as to any changes and/or results.Ticker
FYI, The doctors office referes to this as the "Auxilium 802 Trial"
Hi Humorous,
I didn't notice any swelling or bruising after any of my injections. Just slightly red at the injection sites, though that didn't last too long. They said today that the more stretching I do on my own, the better the results will be.
Quote from: ronners on January 15, 2011, 09:10:06 AM
Mike - I think it's important to bear in mind that whilst they are related, the two conditions are in two totally different parts of the body - what follows with one does not necessarily follow with the other ...
It seems reasonable to assume that much of the swelling and bruising shown in the video is down to the manual manipulation that needs to occur with Dupuytrens after the injection in order to snap the chord - this is clearly quite a traumatic and painful event; other treatment videos suggest similar results ... it's quite normal to assume that the hand would swell and react after an event like this ... whilst you have detailed the modelling aspect of the peyronie's trials, this is quite clearly not on a par with the manual snapping of the chord that needs to take place after xiaflex treatment for dupuytrens ...
I think it's also more likely that repeated injections into the same area could cause the skin damage - the subject talks of bleeding in the video and this is more likely to be as a result of repeated injections into the same site as opposed to her skin being dissolved from the inside out ... either way, she seems very happy with the results ...
as you know the drug was only approved for dupuytrens last year - long term trials are not yet complete although it is thought that xiaflex will reduce but not eradicate recurrence
Right, well I just meant that in the first video she posted (just after the injection - no snapping) she had really bad swelling and brusing. She posted one a few days later after the manipulation to snap the cord...which she said was horrendously painful because in the trial, they were not allowing lidocaine. These were on different days. She was extremely swollen and bruised from the shot alone. At least that's what I understood from her videos. I just think the penis would show similar swelling and bruising to the hand - that's all. For all I know, maybe it
does cause that, and I am getting the placebo...and Humorous is getting the real thing & having the real reaction. Certainly, my penis looked quite a bit like her hand after verapamil shots - so that kind of reaction isn't out of the question for injections to this part of one's anatomy.
About recurrence - she only mentioned that vaguely in the video description - and it is also over 2 years later. So, I am not sure that we know it truly "came back" or if it's a new cord or what. It seems like DC may be more of a progressive condition but it's hard to say. Peyronies Disease may be equally progressive... and so I wonder if xiaflex even does work, could the plaques come back? I think doctors are trying to be optimistic about the body's ability to heal the area once the plaque is dissolved but Peyronies Disease is a healing disorder to begin with - so that optimism may be too strong. It's less risky & traumatic than surgery, certainly...so for that reason - I'd take this any day. If it is a progressive disease, then maybe people with it will have to be on pentox for life after xiaflex.
You're right - the bleeding in the DC youtube video was probably from the needle. Her description was just a little macabre about the whole thing.
Anyway, Ronners - I dont think i noticed any plauque change... but I don't really know if I am comparing it effectively to November. It's possible that it is softer on one side. It is hard to compare to my own memory since the changes aren't really that noticable. The plaques are all there, probably the same size - but maybe softer in 1 spot (but again I might not be getting xiaflex).
Mike - I think DC is definitely more of a progressive condition - it regularly affects more than one finger and at different speeds too (i.e. contracture in one finger is more progressed than contracture in others) ... I suppose with 'traditional peyronie's' (whatever that is!!) the disease tends to stabilise one the acute phase is passed ... with peyronie's you only have the one 'finger' to worry about although I think I would prefer Dupuytrens if I had been given the choice ...
anyhow, here is some auxilium data about recurrence rates for your info: http://www.checkorphan.org/grid/news/treatment/auxilium-pharmaceuticals-announces-two-year-recurrence-rate-of-19-3-for-joints-treated-with-xiaflex-r
It would appear that with Dupuytrens at least, the recurrence rate with xiaflex is lower than with the two other forms of treatment (NA and Surgery) - remember that Xiaflex is being touted as a treatment and not a cure ...
Hard to say about the swelling after injection and I get where you're coming from - whilst you could say it's odd that you reacted after Verapamil but not with the xiaflex (or placebo), at the end of the day different people react differently to different drugs at different times ... so I guess time will tell - either way I'm really pleased that you and the others have seen some mild improvements so far and it's great that you are taking the time to post the details here for us to read - there is the possibility of open label trials for Xiaflex in the UK with Pfizer (who are marketing the drug in the EU) and so I am going to speak to my uro and see if I can get involved (I may not qualify as my plaque is not always palpable) ...
Quote from: Chopsuey on January 17, 2011, 06:58:42 PM
Hi Humorous,
I didn't notice any swelling or bruising after any of my injections. Just slightly red at the injection sites, though that didn't last too long. They said today that the more stretching I do on my own, the better the results will be.
if that's the case is a VED too much for this purpose?
BSSS,
I am pretty sure they ask you not to use pumps during the study... maybe double check with the doc or see if it is on the informed consent. I think it's more of an issue of control (over varibles that lead to improvement) than of any side effects happening.
BSSS,
When Chopsuey mentioned "stretching" below, he was referring to modeling which we are supposed to do during our Phase 3 trial. This is done by using your hand and bending/stretching your penis in the area where the plaque is. We were provided with an instruction card. Basically, I put my thumb on one side and my index finger on the opposite side (and just slightly higher than the thumb). Then I bend my penis in the opposite direction of the curve. Hold for 30 seconds, release for 30 seconds, and repeat that three times. This is done in the flaccid state.
Concerning using a VED, I'm sure that is forbidden during the trial. Like Mike said, they don't want anyone using or doing anything unauthorized that might change the outcome.
Humorous
thanks guys for the info re: VED and the trial. I'd be tempted too much to use the VED and pop that sucker straight! :) j/k May be too much chance of injury and all using it.
BSSS
Can any of the particpants in the study have tried injectable verapamil in the past? Or is that not allowed.
https://www.peyroniesforum.net/index.php/topic,903.msg28413.html#msg28413
Quote from: restore on January 20, 2011, 05:49:39 PM
Can any of the participants in the study have tried injectable verapamil in the past? Or is that not allowed.
It's OK as long as it was more than three months ago.
For all the criteria follow the link provided by BrooksBro in the mesage between this one and yours.
Humorous
Found this online which details how Xiaflex should be prepared and administered to patients suffering from Dupuytrens Contracture:
https://www.xiaflex.com/docs/pi_medguide_combo.pdf
What's relevant is that there is a paragraph 2.3 a) which states that the Xiaflex solution should be clear and not cloudy ... this might be useful info for the guys doing the trials and wondering whether or not they're on the placebo
I don't think that any study would be so obvious that you could tell at a glance which was which (at least in a double blinded test).
One study I participated in we had to add quinine to the placebo to make it taste as bitter as the real drug tasted. Same would go for cloudy/clear differences.
Tim
@Tim468
I hear ya - it's just a few of the guys here have commented below on the difference in appearance and consistency of the study drug they have been given - as well as their body's reaction to the drug / placebo ... It's quite an intrusive study given the amount of injections involved so I think the info is relevant ...
I have also heard that there is likely to be upcoming Xiaflex (AA4500) trials in the UK ... I am meeting my Uro in March so will post details as and when I have them
I have had zero changes... zero. No improvement in curve... no increase in size... nothing. At best, I am getting the placebo. At worst - I am getting the drug but it doesn't work. I may have scar tissue in the septum or under the corporal bodies which is not being touched by the xiaflex. As I've said before - I have not had any side effects at all - so I am probably getting the placebo. I won't know until a year from now.
I have noticed - possibly - that the dorsal plaque may be thinner... but this could be my imagination. I have taken photographs under identical conditions before I began the study and also 2 weeks after my second injection cycle. The photographs are identical.
My photographs (over the past year) have revealed that the only reason my hourglass deformity went away is because I LOST girth in the rest of my penis... not from xiaflex... but just because I am super lucky. The hourglass area is still less malleable than the rest of the penis. There is some kind of scar tissue running along the tunica in that area....though it is not plaque-like. I don't know if that can ever be resolved.
Well ... just as an outsider looking in ... it appears to me that Auxillium is pretty excited about Xiaflex for Peyronie's. That doesn't really fit with the drug having no positive effect on some patients. It may not fix everything back to normal, but it has got to have some positive effect in a reasonably dependable way for them to be moving forward with it at the pace they seem to be. - George
MikeSmith0: For the sake of all of us, lets hope that you really are getting the placebo instead of the real thing. You mentioned that it would be a full year before you find out what you got, but I was under the impression that participants would find out just as soon as the injection cycle was finished?? Or are they intent on maintaining secrecy throughout the entire study?
I do not have a definite calendar on when they will reveal what group I was in. There are 4 visits after the injections are done - and they wont reveal before those 4 visits are completed. Believe me ill be the first to post here as soon as I know if I had the placebo or not.
4 injections with zero side effects and zero results likely means i am getting the placebo. Collagenase is no joke of a chemical...it's a very strong substance. To not have a side effect would be unusual. 100% of xiaflex recipients in the hand studies had side effects (see the full prescribing information on the xiaflex website). I am pissed bc this has rearranged my calendar for nearly 8 months - work time, vacation time, everything... these visits are very difficult on my schedule. And then i dont get the real drug until 2012 and have to go through it all again. In the meantime, i cant even use pentox or traction!
Sorry ive just been in a bad mood since i finally took the 2 pics and compared them. it's really wearing me out already. over a year of this at my age & how much size i lost is a sick enough joke already.
The silver lining will be if it DOES work when you do get it a few years out. The bummer would be if, after all of this, the drug turns out to be a failure when it comes to treating Peyronie's. But I think the odds are that this thing WILL work and that in the two years you are waiting, they will really get the treatment fine tuned enough to be spectacularly effective. At that point you should be able to combine it with Pentox, Ubiquinol, VED or whatever else you want to throw at the stuff. But sorry they are keeping you in the dock for so long. - George
Quote from: MikeSmith0 on January 30, 2011, 11:08:38 PM
And then i dont get the real drug until 2012 and have to go through it all again. In the meantime, i cant even use pentox or traction!
What would prevent you from just using traction and pentox, even while during the trials? I know they ask you not too but how would they know other wise? I guess you wouldn't want to throw off their statistics either.
Quote from: bigk200 on January 30, 2011, 10:16:03 PM
MikeSmith0: For the sake of all of us, lets hope that you really are getting the placebo instead of the real thing.
Bigk,
Please clarify your post for those of us who don't understand why you hope Mike is getting the placebo.
Humorous
If it's not working for him, then it would be logical to hope that he's receiving the placebo instead of the real thing. Just imagine how dissappointing it would be for everyone reading this thread to realize that he received the real thing and the result was zero improvement?
I was in the prior stage of the Xiaflex trial and received the placebo, no change in my condition.
While currently discussing curvature change on this forum, I would like to point out that in the prior stage of the trial, approx 35% of the men who were in the Xiaflex-modeling group did not achieve the goal, i.e., a 25% improvement in the curvature. However, those who did receive Xiaflex did do better overall as a group than the the placebo group.
Although Xiaflex does seem to be a somewhat effective treatment, it is not a miracle cure and no one know why some men improve and others do not.
Quote from: crashbandit on January 31, 2011, 12:44:01 AM
Quote from: MikeSmith0 on January 30, 2011, 11:08:38 PM
And then i dont get the real drug until 2012 and have to go through it all again. In the meantime, i cant even use pentox or traction!
What would prevent you from just using traction and pentox, even while during the trials? I know they ask you not too but how would they know other wise? I guess you wouldn't want to throw off their statistics either.
Right - they wouldn't know - the risk is that if i am getting the real drug and I combine it with traction or pentox, I could have a serious side effect. And yeah it would screw up the stats in the study - which is a small group as it is. They have 200 on the drug and 100 on placebo as far as I know... so small numbers of people screwing around can throw it off.
Yeah BigK - I hope at this point that I am getting the placebo too. If these are the results from the real drug, then I am really screwed. I think it'll still be FDA approved and it'll still be better than verapamil... but it'll just be interesting to see what insurance does. 3-4k a shot is not an easy sell...and that's just the drug fee. The docs and facilities will charge on top of that. If you need 4 shots... is your insurance really gonna pay 15k? It will be a battle Royale... but I guess most of these are won by the patients in the end. MS and CF have very expensive drugs out there...and HIV does as well - and those are for life. I hope insurance doesn't try to screw people on this.
Quote from: ohjb1 on January 31, 2011, 05:46:01 PM
I was in the prior stage of the Xiaflex trial and received the placebo, no change in my condition.
While currently discussing curvature change on this forum, I would like to point out that in the prior stage of the trial, approx 35% of the men who were in the Xiaflex-modeling group did not achieve the goal, i.e., a 25% improvement in the curvature. However, those who did receive Xiaflex did do better overall as a group than the the placebo group.
Although Xiaflex does seem to be a somewhat effective treatment, it is not a miracle cure and no one know why some men improve and others do not.
This was actually explained to me - in theory at least. Basically, if your scar tissue wraps around your corpora cavernosa and is in the septum, then collagenase is not going to be very effective. I am talking about people who have scar tissue 360 degrees around the corpora - and is not thick enough to be injected everywhere. They might benefit a little from dissolving the top plaque (if it dissolves) but the bottom scar tissue probably cannot be injected safely due to the urethra. Also, hourglassing is caused by a lot of plaque in multiple locations - some of which is also too thin to inject - so i dont think they'll ever be able to cure hourglassing w/ this. They excluded people w/ hourglassing from the trial - so they have some issue with it... though I don't know exactly what that was.
OHJB - Are you getting the open-label product now? Are you still in the study? They told me if i was getting the placebo, i would ultimately get the real thing. I would assume you had the same deal in phase 2?
yes mike, they have kept their word. I will be evaluated shortly and if there are no problems, I will be in the open label study, which means I will get the Xiaflex.
Oh that's good. Let us know how that goes if you get a chance to post. It seems like that was a long wait from when you finished up the study...did they say why this wait was so long? (I'm just trying to figure out when I'll get the real drug, assuming I'm in the placebo group).
And you had side effects too right? Swelling and stuff I think I remember from your old post? I guess the placebo can be irritating too.
Quote from: MikeSmith0 on January 30, 2011, 11:08:38 PM
Yeah BigK - I hope at this point that I am getting the placebo too. If these are the results from the real drug, then I am really screwed. I think it'll still be FDA approved and it'll still be better than verapamil... but it'll just be interesting to see what insurance does. 3-4k a shot is not an easy sell...and that's just the drug fee. The docs and facilities will charge on top of that. If you need 4 shots... is your insurance really gonna pay 15k? It will be a battle Royale... but I guess most of these are won by the patients in the end. MS and CF have very expensive drugs out there...and HIV does as well - and those are for life. I hope insurance doesn't try to screw people on this.
I don't know where I read this, and I could be totally wrong, but I was under the impression that a "course of injections" would cost approximately $4k. I think that's how they priced it for treating Dupuytren's contraction. $15k would be really steep price to pay for something that will likely only provide a partial amelioration of the condition.
Quote from: ohjb1 on January 31, 2011, 05:46:01 PM
I was in the prior stage of the Xiaflex trial and received the placebo, no change in my condition.
While currently discussing curvature change on this forum, I would like to point out that in the prior stage of the trial, approx 35% of the men who were in the Xiaflex-modeling group did not achieve the goal, i.e., a 25% improvement in the curvature. However, those who did receive Xiaflex did do better overall as a group than the the placebo group.
Although Xiaflex does seem to be a somewhat effective treatment, it is not a miracle cure and no one know why some men improve and others do not.
One major difference between the phase II & III trials is that phase III is administering 4 injection cycles vs. 3 cycles in the phase II trial. Maybe a 33% increase in the number of injections will translate into more favorable results?
Quote from: bigk on February 02, 2011, 12:22:20 AM
I don't know where I read this, and I could be totally wrong, but I was under the impression that a "course of injections" would cost approximately $4k. I think that's how they priced it for treating Dupuytren's contraction. $15k would be really steep price to pay for something that will likely only provide a partial amelioration of the condition.
Unfortunately it's 3-4k per injection (before the doctor's fee) for dupuytren's. It may be less than Peyronie's and may even have another name altogether when they brand it. I think it might be an intrinsically costly substance to produce...perhaps... or perhaps they are trying to recover a very large R&D investment & taking advantage of a situation where there are no other non-invasive cures.
From the Dupuytren's Board:
Be sure to check the procedure with your doctor and the coverage from your insurance company. The three doctors I spoke with in California all follow a protocol where one injection is done and if a second is needed it will not be done for at least 4 weeks and each injection requires a vial of the Xiaflex. The insurance company may pay for the first vial but not the second or the third.
If you need three injections your out of pocket may be $900 + $3900 + $3900 = $8700. Auxilum discounts the first vial of Xiaflex and sells it for $3400 but each additional vial or prescription is priced at $3900.
I can have a NA procedure done every 4 years for the rest of my life and the cost will be less than one round of Xiaflex treatments which may or may not last as long as the NA and statistically the Xiaflex has a greater chance of serious complications in terms of ligament and tendon damage - at least that is what my doctor who was involved with the Stanford drug trials told me.
(Found at http://www.dupuytren-online.info/Forum_English/board/dupuytren/questions-about-ddand-xilaflex-injections-0_966.html) Sounds like insurance is only stepping in a little bit for this poster... 8700 out of pocket for a partial cure is really steep... in my opinion anyway. Incision and grafting surgery w/ Levine is billed at something like 40k for his fee, facility and anesthesia (with risk of impotence and sensation loss) but it is reimbursed for less than half of that after insurance coverage. The out of pocket wouldn't be anywhere near 8700 for surgery though (depending on your plan I guess - but that would be a rough plan to be on if it were). Maybe they're looking at surgery costs when they priced this. If you have 4 cycles - as the study is doing, then that's $15,600 + doc fees (8 + 500 I'd guess). So, 19,600 would be the bill for 4 cycles (8 vials) + doctor's time. I think surgery is still more...but reimbursed probably around 15k. Some of the guys on here have posted what they had to pay vs. what insurance paid...if you look around you'll find the figures - but I can't remember what threads they were in.
Good luck!
Yeah, it's not the most comfortable thing in the world...i forgot but i think there are a total of 8 induced erections in the study (4 for the xiaflex and then 4 more later to measure any changes). fun stuff
BSSS,
If you meet the study criteria and don't have any excluding factors, I wouldn't worry much about being accepted. They still need men for the trial.
Like you, my plaque is in the top area also (under the tunica) and there isn't much to feel. However, I had a pretty large angle to begin with. Like the other two guys reporting here, I had a 10 degree reduction after Cycle 1. Hopefully, you will have great results also. We should all be reporting Cycle 2 results in the next 7-8 days.
In your other post you mentioned about being nervous and possibly being embarrassed. The situation is very clinical so I haven't felt embarrassed and don't think you will either once you're in that situation.
Good luck, keep asking questions, and we're all looking forward to your reports.
Humorous
I'm wondering if anyone who has had any success in the xiaflex trials have noticed a softening of the plaque? Thanks
Quote from: Humorous3 on February 11, 2011, 01:49:28 AM
BSSS,
If you meet the study criteria and don't have any excluding factors, I wouldn't worry much about being accepted. They still need men for the trial.
Like you, my plaque is in the top area also (under the tunica) and there isn't much to feel. However, I had a pretty large angle to begin with. Like the other two guys reporting here, I had a 10 degree reduction after Cycle 1. Hopefully, you will have great results also. We should all be reporting Cycle 2 results in the next 7-8 days.
In your other post you mentioned about being nervous and possibly being embarrassed. The situation is very clinical so I haven't felt embarrassed and don't think you will either once you're in that situation.
Good luck, keep asking questions, and we're all looking forward to your reports.
Humorous
thanks Humorous3,
Will do on the questions. I am concerned a little about a possible plaque being near the base as well. Seems I remember you can be excluded if they can't inject there and I remember my original uro telling me he felt one there. Guess they'll check that out and will let me know.
I appreciate you guys posting updates here as well; it is encouraging to read them.
BSSS
For you guys who are in the trial, I was wondering how they do the actual injections. Do they run the needle horizontal through the plaque, or is it inserted perpendicular to the plaque? And if they run it through horizontally, is the needle oriented parallel with the centerline of the penis, or is it oriented 90 degrees to the centerline?
My plaque is on the top (dorsal) side of the penis, which also happens to be where the neurovascular bundle is located. So I'm wondering if they do anything special to avoid running the needle through a blood vessel or a nerve?
I actually can't watch him do it... so I don't know exactly - but from what i felt, it's sort of horizontal & also on an angle. My plaque is on top as well. It probably varies for all patients due to the plaque location. I'm not sure about the anatomy of the neurovascular bundle. Verapamil injections have been done for many years so apparently they know how to deal with it.
In my case, I don't know if he does anything to avoid blood vessles or nerves...I assume he knows what to avoid... but either way, I had no bruising or swelling w/ the xiaflex (or placebo). With verapamil, it was very bruised and swollen.
Quote from: MikeSmith0 on February 12, 2011, 04:59:45 AM
I actually can't watch him do it... so I don't know exactly - but from what i felt, it's sort of horizontal & also on an angle. My plaque is on top as well. It probably varies for all patients due to the plaque location. I'm not sure about the anatomy of the neurovascular bundle. Verapamil injections have been done for many years so apparently they know how to deal with it.
In my case, I don't know if he does anything to avoid blood vessles or nerves...I assume he knows what to avoid... but either way, I had no bruising or swelling w/ the xiaflex (or placebo). With verapamil, it was very bruised and swollen.
When it was done, were you able to count the number of needle penetrations through the skin?
Quote from: bigk on February 12, 2011, 02:35:48 AM
For you guys who are in the trial, I was wondering how they do the actual injections. Do they run the needle horizontal through the plaque, or is it inserted perpendicular to the plaque? And if they run it through horizontally, is the needle oriented parallel with the centerline of the penis, or is it oriented 90 degrees to the centerline?
My plaque is on the top (dorsal) side of the penis, which also happens to be where the neurovascular bundle is located. So I'm wondering if they do anything special to avoid running the needle through a blood vessel or a nerve?
bigk,
Like yours, my plaque is also on the top side (under the tunica) and more towards the base than the head. I watch every time they stick me with a needle. It's pretty much as Mike said - it's horizontal but at an angle and the needle tip is "headed for the plaque". It's not straight down/90 degrees from center. They don't go through the tunica but more off center. If you look at the penis as a clock, from my view it is between 10 and 11 o'clock. I'm sure they inject there to avoid nerve damage.
Another thing they do is try to spread the Xiaflex throughout the plaque instead of injecting it all in one place. This is done by "walking" the needle back slightly after injecting some Xiaflex. This also may break up some plaque if they inject, move it back somewhat and then push it forward a little, inject, and then move it back more, etc. It's as if they have your plaque mapped on a grid. This cycle they inject it into Row 1, positions 1, 2, 3 and 4. Next cycle they inject it into Row 2, etc. To answer your other question, they only make one needle penetration into the skin when injecting Xiaflex. The other injection is to induce an erection so they can measure your curve and that's done before the Xiaflex injection.
I think this answers your injection questions but if not, ask away.
Humorous
Quote from: Humorous3 on February 12, 2011, 03:00:35 PM
bigk,
Like yours, my plaque is also on the top side (under the tunica) and more towards the base than the head. I watch every time they stick me with a needle. It's pretty much as Mike said - it's horizontal but at an angle and the needle tip is "headed for the plaque". It's not straight down/90 degrees from center. They don't go through the tunica but more off center. If you look at the penis as a clock, from my view it is between 10 and 11 o'clock. I'm sure they inject there to avoid nerve damage.
Another thing they do is try to spread the Xiaflex throughout the plaque instead of injecting it all in one place. This is done by "walking" the needle back slightly after injecting some Xiaflex. This also may break up some plaque if they inject, move it back somewhat and then push it forward a little, inject, and then move it back more, etc. It's as if they have your plaque mapped on a grid. This cycle they inject it into Row 1, positions 1, 2, 3 and 4. Next cycle they inject it into Row 2, etc. To answer your other question, they only make one needle penetration into the skin when injecting Xiaflex. The other injection is to induce an erection so they can measure your curve and that's done before the Xiaflex injection.
Humorous: So it sounds like the "rows" are parallel with the length of the penis rather than perpendicular to it? And if the injection on the first day is along a "row" in the 10-11 o'clock position, do they try to achieve some sort of symmetry by injecting a similar row in the 1-2 o'clock position a couple of days later?
Quote from: bigk on February 12, 2011, 03:46:19 PM
Quote from: Humorous3 on February 12, 2011, 03:00:35 PM
Humorous: So it sounds like the "rows" are parallel with the length of the penis rather than perpendicular to it? And if the injection on the first day is along a "row" in the 10-11 o'clock position, do they try to achieve some sort of symmetry by injecting a similar row in the 1-2 o'clock position a couple of days later?
bigk,
I used the 4x4 grid as an example of how I think the Dr. views the plaque and how he determines where to inject the Xiaflex to get the most effective distribution. Yes, the rows run parallel with the length of the penis. But for me, and as best as I can remember, the injection site is "always" in the 10-11 o'clock position. Think of the injection site as the "axis" for the needle. The first day (injection #1) he inserts the needle tip into the 10-11 o'clock position and goes to the furthermost part of the plaque of Row1, injects some medicine, and then "walks it back" as described earlier while injecting more medicine. The next day (injection #2) and going into the 10-11 o'clock position again, he inserts the needle tip and goes to the furthermost part of the plaque of Row2, injects some medicine, and then "walks it back" until he is out of Xiaflex. The next cycle he would probably work on Rows 3 and 4. (Depending on the individual's plaque size, grids could be 2x3, 4x5, etc.)
I hope this clarifies the injection process from my perspective.
Humorous
Humorous: So does the injection strategy look like the attached sketch?
bigk,
Yes, it certainly does. I've added an injection point (red circle/dot at 10-11 o'clock), and a syringe (rather crudely) to your very good drawing. The needle tip is at the furthermost point of Row 2. What you have marked as injection sites are where they inject/release some Xiaflex as they walk the needle back.
Your picture makes my words much more clear. Thanks.
Humorous
Humorous: Thanks for taking the time to "tweak" my sketch. From what you have said, it looks like they avoid running the needle directly down the middle so-as to avoid hitting the neurovascular bundle. I've done quite a lot of reading on collagenase in the past few days, and the good news is that collagenase will not break down blood vessels or nerves. But even so, it makes sense that they would try to avoid it as much as possible in order to avoid mechanical trauma that could result from a needle stick.
Quote from: bigk on February 12, 2011, 11:00:44 AM
When it was done, were you able to count the number of needle penetrations through the skin?
Just 1... the protocol only allows for 1 plaque to be treated even if you have more than 1...so they just puncture once. The drawing reflects my experience as well, though I don't understand what the vertical lines you drew mean
They inject exactly where humorous showed...we must have very similar issues...and it feels like the chemical is released as the needle is withdrawn...and as far as the "walking back" thing - yeah that might happen in my case too but I don't watch it. It burns...so it's hard to feel what is going on.
The thing that is a shame is that they will only target 1 plaque - so the optimal results are not achieved in my opinion. Not sure why this is what they settled on with the FDA. Urologists in practice will inject multiple plaques i am sure...and circumferential plaques need multiple injection points.
Btw, it won't break down blood vessles or nerves but i think it CAN break down the tunica if there's too much... that's why penile fracture is a risk in the informed consent. And, possibly why they go so slow - with 0.57 mg * 8 over 24 weeks...rather than higher amounts and shorter time periods.
MikeSmith0: The vertical lines that I drew were meant to denote the path that the needle would take inside the plaque.
One thing I find curious (according to Humorous) is that they only inject xiaflex on one side of the centerline on day one, and they stay on that same side for the injection on day two. I would have thought that they would want to inject equal amounts of xiaflex on both sides of the centerline so that the contracture could release more evenly. If this is correct, then the other side will not receive any xiaflex until the next round of injections 6 weeks later. As I'm writing this, I'm thinking that I am surely mistaken... it just doesn't make sense that they would purposely inject only one side but not the other. Maybe you or Humorous can shed some light on this.
I just received my first injection yesterday. I am excited to be part of this study and there is room for more men to be part of the study. If you are from the Midwest and would like more information on joining the study, let me know and I will get you the contact information. The medicine is extremely expensive and it has a very high success rate.
The first shot was easy, pretty much no pain. Now afterwards there is some pretty extreme swelling and bruising involved and the skin is very sensative like a rash. No really pain unless you run or walk alot due to the sensativity. My shot was around 1:30 PM and my shaft was approx. double in gerth from swelling but no real pain, just uncomfortable. This morning the swelling has gone down but the redness is worse and the sensativity is worse. I have not taken anything for pain since there is so little.
I have to get my second injection tomorrow around the same time, not looking forward to that one. I will update Thursday just in case someone is actually interested.
Please DO update frequently. The more information we can get documented on this web site, the better for it we will all be. Additionally, I and I am sure everyone else here wishes you the very best results from this treatment regimen. Thanks so much for posting! - George
well, the needle goes into the plaque horizontally - all the way across the plaque...so if you enter on the left, the needle goes through the plaque all the way to the right and the chemical is deposited as the needle is withdrawn, so there is even coverage i think....either way you enter....but yes, actually, in my case, one time he went in on the left, and once he went in on the right...same plaque... 1 day apart. some people have more dense / obvious plaques (my case) so it is easier to pass the needle straight through the whole plaque. people with thinner plaques probably have to be injected a little differently.
he said the protocol allows for doctor's discretion with this to an extent...given the variability in plaque size, shape, and density. Also, some people may be sore or bruised still...and i had a red mark so why risk further skin abrasion & re-injecting the same area. the only rule is that you can't really get multiple injections per visit into multiple plaques. and there's only a tiny amount in this vial anyway.. .like 1cc or 2cc at most.
You don't get injected in those vertical line patterns...it's sort of horizontal / diagonal. at least not for a dorsal plaque.
Quote from: MikeSmith0 on February 15, 2011, 10:11:28 PM
well, the needle goes into the plaque horizontally - all the way across the plaque...so if you enter on the left, the needle goes through the plaque all the way to the right and the chemical is deposited as the needle is withdrawn, so there is even coverage i think....either way you enter....but yes, actually, in my case, one time he went in on the left, and once he went in on the right...same plaque... 1 day apart. some people have more dense / obvious plaques (my case) so it is easier to pass the needle straight through the whole plaque. people with thinner plaques probably have to be injected a little differently.
he said the protocol allows for doctor's discretion with this to an extent...given the variability in plaque size, shape, and density. Also, some people may be sore or bruised still...and i had a red mark so why risk further skin abrasion & re-injecting the same area. the only rule is that you can't really get multiple injections per visit into multiple plaques. and there's only a tiny amount in this vial anyway.. .like 1cc or 2cc at most.
You don't get injected in those vertical line patterns...it's sort of horizontal / diagonal. at least not for a dorsal plaque.
You must be correct that the protocol allows for considerable discretion. I'm pretty sure that Humorous indicated that the path of the needle was parallel with the length of the penis, but in your case, the needle was inserted all the way across the plaque (left to right, or right to left) without any concern for hitting the neurovascular bundle. Is the attached sketch an accurate depiction of the injections that you received?
Mathewfamily1,
Glad to hear you're in the Phase 3 Xiaflex trial and that you're reporting your results here. There is a specific forum topic for us in the trial so I'm asking you to consider posting there. It would be to all our benefit. This is the topic to look for:
Thread for Guys in Xiaflex Trial - Currently or Previously
I have had six injections so far (three cycles) and I've had severe swelling and my penis was dark red to purple. However, each cycle this happened only after the second shot. I'm surprised that it happened to you on the first shot. Different people react differently. I'll be watching for your next post after your second injection. Thanks again for posting.
Humorous
I'm an engineer... I like to understand how things work. Sorry if I've caused you any anxiety.
Quote from: bigk on February 16, 2011, 07:44:41 PM
I'm an engineer... I like to understand how things work. Sorry if I've caused you any anxiety.
A wife asks her husband, a software engineer...
"Could you please go shopping for me and buy one carton of milk, and if they have eggs, get 6!" A short time later the husband comes back with 6 cartons of milk. The wife asks him, "Why the hell did you buy 6 cartons of milk?" He replied, "They had eggs."
Yes, here's the link: https://www.peyroniesforum.net/index.php/topic,1458.0.html
The more information we get from those being injected the better. Please do keep us in the loop :).
I will start posting in the specific forum area. New to this so I didn't know there was such a page. All future results will be there.
Quote from: bigk on February 16, 2011, 12:21:06 AM
You must be correct that the protocol allows for considerable discretion. I'm pretty sure that Humorous indicated that the path of the needle was parallel with the length of the penis, but in your case, the needle was inserted all the way across the plaque (left to right, or right to left) without any concern for hitting the neurovascular bundle. Is the attached sketch an accurate depiction of the injections that you received?
i dont know... i dont watch...it was on more of an angle than that i think. the NV bundle is above the plaque.. he knows when he hits the plaque bc it is thick & firm. the very first touch of where the needle goes in lets him know it is the plaque.
i kinda agree with bsss though - now im gonna be nervous he's gonna hit the nv bundle. well, if my VIs and 4 X shots already did not hit it, i assume they know what they are doing in this regard.
Well guys, I am officially a member of your club. Pretty harsh entry fee, the shots!
This past Monday about 1 PM I had my first shot. My plaque is towards the tip, centered and the PA entered the needle from the side straight in. The first shot was pretty painless. They wrapped it up so loose that it didn't stay on very long and was just a lump of gauze in my pants. The 1.5 hour drive home was uneventful, then I got home and showed my wife. By this time it was swollen the size of half a chicken egg on the right side only and just starting to get red, this was about 5:30 PM. By 9:30 PM the shaft doubled in size from normal pretty much all the way around and it was very red with splotches of purple. The odd thing was the head was normal in color and size?!? Tuesday the swelling had gone down about half way but the colors were more even between the red and purple. By Weds. morning, the day of the second shot, the selling was almost all gone but the deep purple was more so than the red. My second shot happened at almost 2 PM. This shot hurt bad, burned like a hot knife that lasted about 3 to 5 mins. This time the doctor thought they should wrap the gauze a little tighter. The ride home was uneventful however when I got out of the car and walk four steps my knees hit the ground. It felt like someone was cutting it off right where the plaque is, it was the gauze wrap. I barely got in the house and down the stairs to get scissors to cut the wrap off. The swelling had no where to go so the base was big and swollen and the skin just under the head was swelling fast. Once I got the wrap cut off the swelling went crazy, especially the skin just under the head towards the underside. It looked like the frogs that blow up the underside of the jaw. The swelling was so bad I really was afraid the skin would rupture but it did not, Thank God. Lots of frozen corn and peas with Advil and Benedril. I woke up this morning to less swelling but still pretty severe. The bruising has now turned to an eggplant purple. The skin is SO sensitive that just walking is very uncomfortable. I really didn't think that it would be this bad but in the end, if it works, it will have been worth it. I am only 36 and I have a lot of lovin' to give to my wife.
Quote from: Mathewfamily1 on February 17, 2011, 04:56:54 PM
Well guys, I am officially a member of your club. Pretty harsh entry fee, the shots!
This past Monday about 1 PM I had my first shot. My plaque is towards the tip, centered and the PA entered the needle from the side straight in. The first shot was pretty painless. They wrapped it up so loose that it didn't stay on very long and was just a lump of gauze in my pants. The 1.5 hour drive home was uneventful, then I got home and showed my wife. By this time it was swollen the size of half a chicken egg on the right side only and just starting to get red, this was about 5:30 PM. By 9:30 PM the shaft doubled in size from normal pretty much all the way around and it was very red with splotches of purple. The odd thing was the head was normal in color and size?!? Tuesday the swelling had gone down about half way but the colors were more even between the red and purple. By Weds. morning, the day of the second shot, the selling was almost all gone but the deep purple was more so than the red. My second shot happened at almost 2 PM. This shot hurt bad, burned like a hot knife that lasted about 3 to 5 mins. This time the doctor thought they should wrap the gauze a little tighter. The ride home was uneventful however when I got out of the car and walk four steps my knees hit the ground. It felt like someone was cutting it off right where the plaque is, it was the gauze wrap. I barely got in the house and down the stairs to get scissors to cut the wrap off. The swelling had no where to go so the base was big and swollen and the skin just under the head was swelling fast. Once I got the wrap cut off the swelling went crazy, especially the skin just under the head towards the underside. It looked like the frogs that blow up the underside of the jaw. The swelling was so bad I really was afraid the skin would rupture but it did not, Thank God. Lots of frozen corn and peas with Advil and Benedril. I woke up this morning to less swelling but still pretty severe. The bruising has now turned to an eggplant purple. The skin is SO sensitive that just walking is very uncomfortable. I really didn't think that it would be this bad but in the end, if it works, it will have been worth it. I am only 36 and I have a lot of lovin' to give to my wife.
Thanks for the detailed account of your experience. What is the starting angle that you're trying to correct? How many times did the doc. insert the needle? From your description, it sounds like you got a shot (or "shots"?) on the right side on day one, and then another shot(s) on the left side two days later?
I'm curios about the Xiaflex injections. I had Verapamil injections and they always first gave me a numbing injection first. This was done with a much smaller gauge needle with two injections, one on either side of the base of the penis. Then they waited about 10-15 minutes before actually doing the VI. I'm curios if they also do the numbing injection prior to the Xiaflex injection.
Quote from: lwillisjr on February 17, 2011, 07:47:32 PM
I'm curios about the Xiaflex injections. I had Verapamil injections and they always first gave me a numbing injection first. This was done with a much smaller gauge needle with two injections, one on either side of the base of the penis. Then the waited about 10-15 minutes before actually doing the VI. I'm curios if they also do the numbing injection prior to the Xiaflex injection.
I had the VI injections too and these shots are less painful and less invasive. These shots are short and the needle is extremely small. However the drug burns when it gets injected the second shot.
BigK
I am starting at 55 degrees of curvature. The doc gave me both shots on the right side in the same location only inserting the needle in once.
Quote from: lwillisjr on February 17, 2011, 07:47:32 PM
I'm curios about the Xiaflex injections. I had Verapamil injections and they always first gave me a numbing injection first. This was done with a much smaller gauge needle with two injections, one on either side of the base of the penis. Then they waited about 10-15 minutes before actually doing the VI. I'm curios if they also do the numbing injection prior to the Xiaflex injection.
lwillisjr,
They offer to give you the numbing injection if you want it. My choice was to get one injection instead of two. The needle they use to inject the Xiaflex is very small gauge so it isn't very painful.
Humorous
I've finished the Cycle 3 injections. But since they measure you before the Xiaflex is injected, first let me say there was a 10 degree improvement from the Cycle 2 shots. Add that to the 10 degree improvement from Cycle 1 and that makes me pretty happy. The Dr was pleased also.
Back to the injections. The first one was no problem, as usual. Maybe a little redness at needle entry point but no swelling. The second one (given the next day) is the "bad" one. I've swollen substantially and turned dark red to purple the first two cycles. But for some reason, this time was different. While there was some swelling and redness, it was nothing like before. That was a pleasant surprise. Now I'll model (when I remember) and wait for the measurement at the next cycle in six weeks.
When you combine the 20 degree improvement and the reaction to the injection every cycle, I think it's safe for me to say (the Dr can't, of course) that I'm getting Xiaflex and not the placebo.
Humorous
Quote from: Humorous3 on February 18, 2011, 02:00:17 AM
I've finished the Cycle 3 injections. But since they measure you before the Xiaflex is injected, first let me say there was a 10 degree improvement from the Cycle 2 shots. Add that to the 10 degree improvement from Cycle 1 and that makes me pretty happy. The Dr was pleased also.
Back to the injections. The first one was no problem, as usual. Maybe a little redness at needle entry point but no swelling. The second one (given the next day) is the "bad" one. I've swollen substantially and turned dark red to purple the first two cycles. But for some reason, this time was different. While there was some swelling and redness, it was nothing like before. That was a pleasant surprise. Now I'll model (when I remember) and wait for the measurement at the next cycle in six weeks.
When you combine the 20 degree improvement and the reaction to the injection every cycle, I think it's safe for me to say (the Dr can't, of course) that I'm getting Xiaflex and not the placebo.
Humorous
nice news to hear Humorous! Hope the good results continue!
That's fantastic news Humorous3. I'm heartened to hear of your improvement and am very happy for you :). Let's hope there are many more positive reports over the coming weeks and months.
Great news :)
I was in the prior phase of the drug trial and received the placebo - no change at all.
I see a number of posts on this thread where men who have noticed a change for the better automatically assume that they received Xiaflex and not the placebo. If you read Auxillium's own results from Phase II of the clinical trail you will note that a significant of percentage of men who received the placebo also improved - so much so that they met the goal of 25% improvement. This is a mysterious finding.
Of course, its all postive to improve, but erroneous to assume it was due to the Xiaflex. Hopefully, as results of the current phase of the trial come in we will all know more.
I'm curious to know, of the people who have "measured" improvement from their injections, have you noticed "real life" improvement? Also, I am also curious to know if the injection is causing any kind of softening, shrinking, or dissolving of scar tissue.
Me too. Any softening of the plaque (scar)? Also I remember Dr. Mulhall when telling me about the verapamil treatments that he felt pretty sure that it was more the swisscheesing effect than the verapamil which caused any improvement.
Quote from: ohno on February 20, 2011, 03:23:49 PM
Me too. Any softening of the plaque (scar)? Also I remember Dr. Mulhall when telling me about the verapamil treatments that he felt pretty sure that it was more the swisscheesing effect than the verapamil which caused any improvement.
I've been doing quite a bit of reading on how collagenase works, and I suspect that the plaque doesn't get softer, but instead, it just gets smaller. When the medicine is injected, it affects an area of about 1.5 to 2 mm near the injection point. So the total diameter of the affected area would be 3.5 to 4 mm. Since they give two injections in each cycle along a line perpendicular to the long axis of the penis, and assuming that the second injection is offset by 1 or 2 mm from the first one, it's plausible that the zone in which plaque is eradicated would be approximately 6 to 7 mm wide.
It turns out that a 60 mm long plaque will result in a 90 degree bend. So the length of plaque resulting in a 10 degree bend would be 6.7 mm. Based on the zone over which the medicine should have some action, and based on the amount of plaque that must be eradicated to achieve a 10 degree improvement, it totally makes sense to me that Humorous3 has had a 10 degree improvement with each injection cycle. I therefore suspect that he is receiving the real medicine instead of a placebo.
If Auxillium keeps the same pricing structure as it is for Dupuytren's disease, then it appears that it will probably cost about $7,500 for every 10 degrees of improvement that is required. And so if you start out with a 90 degree bend, the total cost could end up being 9 times $7,500, which equals $67,500. Let's just hope that they come up with a new pricing structure that's more reasonable than that. I've heard of the $6 million dollar man, but it seems kind of crazy to have $68,000 penis!
bigk - that's a very speculative post? humourous isn't the only one in the study (results will vary) and one would presume an approved treatment won't be priced 3-4 times higher than basic surgery ... I'd be interested to hear views on how this drug affects the plaque from qualified urologists involved in the study if any of the trial participants would care to ask and post - I feel that would be more useful to the people following this thread.
bigk's post was interesting...i am a quantitative person too so i can appreciate that analysis - but i don't know that you can actually quantify this as precisely as he did & say it is that uniform. however, it's an interesting calculation...i'm not sure where all the numbers come from in terms of X mm = x degrees of curve, etc. There are a lot of variables affecting this curve (plaques can be in the septum, laterally oriented, and under the corpora as well - some are thicker than others, penis size varies, etc...). Also re: his analysis - If you think of another injectable like botox, you can somewhat quantify how far the paralyzing will go per each number of units in injected. It may be apples and oranges to compare these two though.
I think xiaflex softens the plaques, dissolves the plaques, and also lets them detatch from the tunica...as well as potentially triggers a more appropriate healing response once some of the plaque is broken down. That's the general idea of what has been explained to me by the docs but nobody knows "exactly" what it is doing under the skin...but that is the general intent of the drug.
The pricing will be rough. 4k x 8 injections is just really high for most insurers. Chemotherapy, MS, HIV, and CF drugs are like this in terms of price too, however...some of these are much more life & death than Peyronies Disease (though Peyronies Disease's affect on quality of life is severe in many cases) so perhaps the battle wont be as bad. The DC crowd had a few months of battling but auxilium has staff working with the major insurers to explain the drug fortunately. The alternative to X for the DC crowd is a procedure that's fairly reliable and relatively lower risk. The alternative to X for Peyronies Disease is a very invasive surgery with nearly guaranteed loss of size, potential impotence, and potential sensation loss...so I'm sure the AUX team has their powerpoint slides ready & waiting for blue cross, aetna, etc...
The other problem is that it won't be on the market for a long time, I don't think...based on the Xiaflex calendar with DC. It took a while even after phase 3...which I think is done at the end of 2011.
I found the information regarding 90 degrees of bend per 60 mm plaque at this link: http://peyronies.org/pages/mechanics.htm.
And I found the information regarding a 2mm radius from the injection site at this link: http://www.patentstorm.us/patents/4338300/description.html
I took some time to read the Auxilium phase IIb results, and it looks like the average angle of improvement was a little less than 6 degrees per injection cycle. So a 10 degree improvement per injection cycle is definitely on the high side, but certainly not out of the realm of possibilities.
When collagenase is used for duputren's, they inject nearly all of the medicine into a very localized area in the cord, and even after doing that, they still have to work pretty hard to "snap" the cord. So it kind of makes sense that using it for Peyronie's will require multiple injections due to the large volume of plaque that has to be dissolved and/or softened.
hi i am a newbie in this forum, i would like to know whether xiaflex is suitable for someone who has peyronies for 10 years +? My penis is not bent but it is pointing downwards and not flexible. Masturebation is ok but sex is difficult. The only treatment that i tried was vitamin E and L-arginine it did not give much effects at all.The base of my penis is hard, i guess its the fibrosis plaque. And may i know when will xiaflex made available for the public?
thank u..
Quote from: burnoutz2010 on February 22, 2011, 01:56:07 AM
hi i am a newbie in this forum, i would like to know whether xiaflex is suitable for someone who has peyronies for 10 years +? My penis is not bent but it is pointing downwards and not flexible. Masturebation is ok but sex is difficult. The only treatment that i tried was vitamin E and L-arginine it did not give much effects at all.The base of my penis is hard, i guess its the fibrosis plaque. And may i know when will xiaflex made available for the public?
thank u..
I'm not sure if you are asking if you'd be eligible for the study or if you can just get the drug?
From what I've read you have to have a certain amount of curvature in your penis and that can't be downward or that would exclude you from the study.
As for a release to the public, I'm not sure. I do know the current phase of the trial lasts until March 2012. I don't know how long the open label part lasts or how long it takes for them to gain FDA approval. If you're waiting for it to be released it could be 2 to 3 years I would think.
Sorry I don't have more or better news.
BSSS
well i have had no results... no side effects...and a smaller penis every time i look at it.
MikeSmith0: I'm really sorry to hear that you're not getting the real stuff. Just today I'm considering going to see a shrink to ask about getting some meds... this is the most God awful thing I've ever had to go through, and I have definitely been through some big health scares in the past.
If you would like to complain about the stupidity of having a placebo group for these trials, you can do so by going to this link:
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplaintsrelatingtoClinicaltrials/default.htm
And if you are interested in getting another opinion for surgery, you might want to check out Dr. Gelman in California. I called his office with some questions, and much to my surprise, Dr. Gelman actually called me back himself. If I ever have surgery, I think he will be my first choice. Here is a link to his website:
www.centerforreconstructiveurology.org
Mike,
Trust me, I feel your pain. I tried to get into a trial in Kansas, but I was turned down because of taking pentox. They said I would have to be off the drug for 90 days and they were closing recruitment in 30 days, so they were going to get someone else. I was relieved and disappointed at the same time. I guess at least I don't have to worry about being in the placebo group.
At the same time all this was happening, one of my coworkers was having triple bi pass heart surgery and one of my best customers had a heart attack while shoveling snow. He was in the hospital for 15 days; he is home recovering now.
So, I sat back and thought to myself...well, at least I didn't have a heart attack. And, hey, I'm going to live to fight Peyronies another day. Somehow, those thoughts made me feel better and I went back to thinking about my improvement so far with my VED and oral supplements.
Although Peyronies is a terrible and terribly frustrating disease, things could always be worse. Try your best to hang in there.
GS
Thanks guys... I was in quite a mood when I wrote that. The reason I said I'd rather have cancer (or I guess even a heart attack) is because people understand that and you can discuss that openly. I can't go to my (female) boss and say "I'm going to be gone for 3 days while my penis is injected and manipulated by a urologist in an experimental FDA trial with an enzyme to break down the plaque causing the curve and hopefully make my penis normal again". Even though I have a tremendous amount of flexibility with what I do (thankfully) - the psychological toll of this affects my work & there are periods where I am unproductive or what I do produce is far below my abilities and the standards here. I just want people to know that there's something affecting me but I can't really say it. If I am vague, then they think I am malingering. If I say the actual problem, it is pretty shocking & everyone involved would be uncomfortable. So, on that front... cancer or a heart attack would be better. I have been so adversely affected by this that I may not have a job in the future...who knows. My performance is terrible & the xiaflex trial is a distraction as well. If I had a more rigid job, I'd really be in trouble -- I'd have no way to do the trials & people would see me on a daily basis feeling like crap. I am on some psychological medication but it doesn't really help... like, in my case - any time I go to a therapist for something, talking about it makes it worse. I just have to fix it. For a while I had issues with certain things at work, with family, or with other health problems. Therapy never helped. Once I fixed those problems, I was better. Not being able to fix this at all (and I've seen so many urologists -- with some weird hope that there's a secret cure out there or that they'll actually agree on an approach - when in reality, they all disagree)...not being able to talk about it (particularly to explain my poor performance at work) is really what is making me crazy. I could tell my boss I am in this FDA trial and it's been stressful and maybe she'll understand some of what's been going on with my work quality - but at the end of the day, if my work quality is bad and I can't manage all this then I have no business working here...and that's the hint I already got in December... with this "progress management letter". I have never been like this in all the years I have worked...but to say this is a distraction is an understatement.
BigK - his website looked interesting. I am really really searching for a doc who will do some kind of size restoration procedure and all I can find is some guy in Serbia who uses PLGA scaffolds & maybe you get 0.5-1 mm girth. I have a lot of reservations about this to say the least... but that's one option out there I guess. I think they incise the peyronie's plaques during that surgery too - to release their tension.. but the penis looks a little odd after that because the head is not augmented. Also, it's a lot of risk and money and headache for 1mm girth... and god knows what will happen post-op from that. It's not FDA approved, so I'd have to go to Serbia which is just... not something I'd ever imagine doing.
Mike:
I fully understand how you feel. I've had some rough times in my life, but I would gladly go through all of it over again if I had my old penis back. It's funny that I used to be somewhat dissatisfied with my old penis, now what I wouldn't give to have it back. The mental aspect of it is the worst. I've pretty much tried everything and I'm not convinced that it would be any different if I just sat back and did nothing. Everytime I think it has stabilised or maybe I'm getting better, I'm crushed a week later when it ends up being even worse than before. If I wake up and my penis feels nice and soft and flexible with no pain, I get excited. The next day I'll wake up and it will be hardened, painful and inflexible like a roll of quarters (more like a roll of dimes now with all my lost girth). It's a mental rollercoaster I wouldn't wish on anyone.
The only thing that keeps me going is thinking that someday it will stabilize and things will get better. The way I look at it though, after xiaflex, there really aren't any new drugs or treatments even on the horizon, unless Dr. Levine can inject us with these "missing enzymes" I've heard about lol. So it looks as if we're all stuck with the same old ved, pentox, and traction for a while, and if they don't work for someone, then you're sol. It sucks being in that 5-10% category that gets Peyronies Disease in the firstplace, and if you're under 40 it's more like 1%. Then if you're in that unlucky 40% category of men who get it, but get worse over time, even with that hairy "only 11% get worse" on pentox statistic. It's such a longshot in the worst way possible.
One thing we can all agree on;Peyronies disease is a Son of a Bitch, and that's putting it mildly.
As I mentioned in my earlier post, I had mixed emotions about whether I really wanted to be in the trial because of the fact I may be wasting my time with the placebo. But, I might not be wasting my time and I might get cured of Peyronies Disease in the trial and not have to spend a bunch of money on the injections later on after it all gets FDA approval. Also, I'm 60 years old and by the time it all gets approved, I might not even care anymore.
Then, there's the question of "if I'm getting the placebo, do I quit the trial?" But, if I'm getting the placebo, they will give me the real drug after the trial and won't charge me. And, on and on it goes.
So, again I say "I feel your pain".
GS
Hi guys,
I just had my third evaluation and no change in the curvature. I am really disappointed and think I am probably getting the placebo. I really had my hopes up about getting the drug and seeing some improvement. This condition really sucks. After the first follow up evaluation, it seemed as though I had about a 10% improvement, but I think that had to do with not getting as much of the medication that induces an erection. The initial evaluation he must have given me a healthy dose because it took quite a while for me to go down and he had to inject three times with the drug used to bring you down. That was a lot f**king fun that day. So, I continue the exercises and go for another injection tomorrow, the second in the third cycle. At least I know I only have one more cycle after this one and then no more injections until the study is over. I asked my doc about the fact I'm not seeing any results and he said it could be the placebo or it just may not be working on me. He said the drug isn't effective for everyone. I don't know what's worse, getting the placebo which means getting a crap load of shots for no good reason or actually getting the drug and finding out it doesn't work on you. At least with the placebo I will supposedly get the real drug when it's all over with.
Hey Mike, I feel for you brother. It's too bad about you losing size, but at least you started with more than me. I'm losing and I started with less than than you. I always wanted to be bigger than I was, let alone f**king lose what I had. Oh, and not only lose some length and girth, let's f**k it up a little more by adding a double curve and put a nice size dent in the side of it. Really makes you want to drop your pants for your wife or girlfriend...huh? WTF
GS:
No, GS, Peyronies Disease is not a son of a bitch! It is the mother of all bi+
Women have their breast cancer that causes total fear in their lives. They think losing a breast or both of them is the end of the world. Except for those terminal cases, they do have the ability to continue their lives even if it does require an artificial breast or maybe both.
Peyronies Disease does in some cases bring on total ED as a result. Women just cannot understand what this does to a man's psyche. The ability to have sex and reproduce is embedded in their minds from birth. And, losing that capability causes much havoc in men.
So, bottom line, we endeavor at all costs to retain that ability even though man can live a total happy life without sex. (OK, some will disagree with that statement!)
Old Man
Too all
It seems for some reason we all are feeling alot of emotion and pain for all who are sufferinng and our selves.Before we are born our parents pray we have all our fingers and toes and all our faculties intact.when we are born and are fine they lay out a big breath. As life goes on there is no promise that we will leave life with all that we were equipped with.War, disease, accidents anything can happen at any moment and take it all away .
Do we wait for alien technology or do somthing about it? I do not know? Do we set up a fund of some kind outside of this forum with the help of lawyers.Money talks it might help us find a researcher to research this f%%disease.
This is not the mothers of all bi+
So there is my rant I might as well put my 2 cents out there .Obviously I'm not afraid to put my foot in my mouth.That is an amarican expression for those who are unaware of the term.Meaning i said somthing and have no audience and will regret it later.
Fubar
Mike,
Hang in there. We're 3/4 of the way there - just one more cycle to go. Then a few evaluations and it's over. After that you will get the real drug and be on your way to a "better you". Another way to think of it is you'll be saving $32-40K by finishing the trial. (I think those are the figures you've used before.) To me, that's quite a return on investment.
Humorous
Quote from: Chopsuey on February 24, 2011, 07:49:35 PM
I always wanted to be bigger than I was, let alone f**king lose what I had. Oh, and not only lose some length and girth, let's f**k it up a little more by adding a double curve and put a nice size dent in the side of it. Really makes you want to drop your pants for your wife or girlfriend...huh? WTF
Ha... exactly! I started around 6.75, maybe more if I really worked on it... I used to measure it in my late teen years / early 20s and then sort of just didn't care after that.
I suppose the ROI of being in the study with a placebo is worth it... however, I am losing more size. I would drop out tomorrow if someone had a surgery to fix this. The PLGA scaffold procedure in Serbia has ruined a lot of guys...so I am scratching that off the list. Alloderm and fat injections also both lead to big problems.
I think everyone can agree, Peyronies Disease is nasty, like a tapeworm in your penis that sucks all the life out of it, but back to the thread and Xiaflex:
I have a few questions for the guys who have gotten the real drug:
1) We are not sure about the mechanism after the drug breaks down the collagen fibers, meaning we don't know exactly whether or not collagen is replaced with new healthy tissue, new scar tissue, or just a thinner tunica. Do any of you notice a change in elasticity? Is it softer, harder, or more or less flexible?
2) Has anyone noticed an increase in stretched or erect length? Is it something they measure or just curvature?
3) any changes in erectile function or dysfunction?
4) Do they give you additional ultrasounds after each phase to determine how the plaque or makeup of the tunica has changed?
thanks
-chefcasey
chefcasey,
I think some of your questions can be answered by reading the document found at this link: http://www.patentstorm.us/patents/4338300/description.html
Quote from: bigk on February 21, 2011, 01:11:52 AM
I found the information regarding 90 degrees of bend per 60 mm plaque at this link: http://peyronies.org/pages/mechanics.htm.
And I found the information regarding a 2mm radius from the injection site at this link: http://www.patentstorm.us/patents/4338300/description.html
I took some time to read the Auxilium phase IIb results, and it looks like the average angle of improvement was a little less than 6 degrees per injection cycle. So a 10 degree improvement per injection cycle is definitely on the high side, but certainly not out of the realm of possibilities.
When collagenase is used for duputren's, they inject nearly all of the medicine into a very localized area in the cord, and even after doing that, they still have to work pretty hard to "snap" the cord. So it kind of makes sense that using it for Peyronie's will require multiple injections due to the large volume of plaque that has to be dissolved and/or softened.
wow you are a great cyber sleuth. I can't believe I never found this in all my Peyronies Disease research! Thanks so much for posting this. I don't understand much of it at all... but it's interesting. Where does it say how much plaque is dissolved per injection? It is so confusing to me what they freeze dried, what was human, what was animal, etc...very complicated...and not scanned in well (the punctuation and words are mushed together sometimes)
Interesting to note that the drug targets the plaque more than the tunica (did you read that in there too... I could have mis read it) -- that's really quite important & i am surprised my doctor didn't mention that.
Casey, I am getting the placebo but I can answer 2 questions for now... hopefully others will answer the other questions bc I am curious about the answer too.
2) Has anyone noticed an increase in stretched or erect length? Is it something they measure or just curvature?
- They measure stretched flaccid length (which is never equal to erect length though...) and they measure the curve. They do not measure girth in any state. They are not concerned with aesthetics and size issues... basically. They give you a chart to track how much vaginal penetration you are having -- and that is the main outcome measure they want to see aside from the curve reduction. If you never regain girth or length, but you can have vaginal penetration again (due to reduced curve), the drug will be considered a success and the FDA will approve it. Xiaflex isn't causing size loss at all to my knowledge- but size regain is a big open question... i'd think it would be able to help regain size... but perhaps this would take >1 year for the body to rebuild the tissue properly...if it even can. I think if it breaks down the scar, it might leave the penis with a hinge effect that is even worse. Not sure... am very curious about the other guys' opinions. I do know that "vaginal penetration" is a big deal for them. Otherwise, it's virtually a cosmetic drug.
4) Do they give you additional ultrasounds after each phase to determine how the plaque or makeup of the tunica has changed?
- No ultrasound after the first screening visit. It's not an exact science...the ultrasound. The machines are all different at different sites and the resolution varies... calcification is obvious when present but quantifying the size and thickness of plaque is beyond what an ultrasound can do. A 3D cat scan might be able to do this, but that level of radiation is probably not something anyone would want...or would even be necessary for this kind of study. I'd be curious what an MRI would show - with or without contrast dye. I never heard of anyone getting an MRI of the penis. MRIs are very safe... though costly - they might be useful way to understand the progress of the disease.
MikeSmith0 - thanks for that information.
Vaginal penetration is what they are measuring? Yoiks. I can think of so many reasons why this is a flawed system from the outset. It ignores the relationship between a man and his penis. It excludes men who have male partners (and I imagine the issues there are even more complicated, especially if one person has Peyronies Disease and the other does not. I mean, usually for straight guys they are the only guy in the room during intimate moments, so there are no unflattering comparisons...)
I look forward to the results as these trials continue. I am assuming I will need some kind of therapy later - when the plaque returns. I am hoping it does not return until there is an effective treatment.
Yes, the study explicitly excludes gay people and single people. This was mandated by the FDA. I am not sure why...One doctor said it has something to do with the surveys that they give you (that are validated scales in research) - and another doctor says that the FDA does not care about gay sex as "it serves no biological purpose" and god knows what administration appointed the people who work there these days. And, single people can't report vaginal sex "regularly" enough to satisfy the FDA. (I did some questioning about this out of curiosity.) These are NOT my opinions... I think it's ethically wrong to exclude gay people from the study...and single people.
I have had gay friends over the years, so I have been privy to a lot of their conversations about sex. All I can say is thank god women don't talk like they do about dicks (or maybe they do...and I just don't know). I've even seen their online personal ads where they basically meet each other based on pictures of their dicks! Could you imagine? From what I gather from them (one of whom I told about my condition) it would have a much more negative affect on single gay men than it would have on heterosexual married men. However, the FDA is not interested in making gay men feel better about their penises. Vaginal sex is their outcome measure... plus there are some surveys about if you are nervous having vaginal sex, etc... I think there were some questions about anxiety and depression at the first visit survey - but only 2 or 3 at the most. So, you have to "be in a relationship" to be in the study. I am in a relationship... a crappy one that is going nowhere...but enough of one to have bad vaginal sex once every 3 weeks to qualify for the study. Woo hoo. I hope I am still in this relationship by the time the placebo is over and I get the real drug... if not, I am not going on the dating market with a tiny shrimp cocktail penis thanks to Peyronies Disease. Hell No.
Quote from: MikeSmith0 on February 26, 2011, 05:48:46 PM
Casey, I am getting the placebo but I can answer 2 questions for now... hopefully others will answer the other questions bc I am curious about the answer too.
2) Has anyone noticed an increase in stretched or erect length? Is it something they measure or just curvature?
- They measure stretched flaccid length (which is never equal to erect length though...) and they measure the curve. They do not measure girth in any state. They are not concerned with aesthetics and size issues... basically. They give you a chart to track how much vaginal penetration you are having -- and that is the main outcome measure they want to see aside from the curve reduction. If you never regain girth or length, but you can have vaginal penetration again (due to reduced curve), the drug will be considered a success and the FDA will approve it. Xiaflex isn't causing size loss at all to my knowledge- but size regain is a big open question... i'd think it would be able to help regain size... but perhaps this would take >1 year for the body to rebuild the tissue properly...if it even can. I think if it breaks down the scar, it might leave the penis with a hinge effect that is even worse. Not sure... am very curious about the other guys' opinions. I do know that "vaginal penetration" is a big deal for them. Otherwise, it's virtually a cosmetic drug.
4) Do they give you additional ultrasounds after each phase to determine how the plaque or makeup of the tunica has changed?
- No ultrasound after the first screening visit. It's not an exact science...the ultrasound. The machines are all different at different sites and the resolution varies... calcification is obvious when present but quantifying the size and thickness of plaque is beyond what an ultrasound can do. A 3D cat scan might be able to do this, but that level of radiation is probably not something anyone would want...or would even be necessary for this kind of study. I'd be curious what an MRI would show - with or without contrast dye. I never heard of anyone getting an MRI of the penis. MRIs are very safe... though costly - they might be useful way to understand the progress of the disease.
Mike the first thing I had done when I went to see my general uro was go get a mri after he examined me. He said everything looked fine from what he could see. Now they didn't just mri my unit, they did my whole mid section with focus on it. But he couldn't see anything wrong.
Based on the exclusion criteria of the study, you pretty much need the most basic type of Peyronies Disease. Singles and gays are excluded, hourglass deformity is excluded (which doesn't make much sense to me, scar tissue is scar tissue even if it happens to be in a semi-circle), any type of ventral curvature(seriously?).
It seems like the company is trying to make it so they can inject the drug into only the most basic types of deformity and under certain degree criteria in order to achieve the best results in the study and get it FDA approved. Based on what I see in the preliminary outcomes, it seems to have no more positive statistical significance than any other studies I've seen ranging from VI's to EWST. From what I take away from the study, if you have a simple curvature located in one spot of plaque ranging from 30-90 degrees, with confidence there's a 67% chance of 25% improvement in curvature. If anything it seems like it will be the new alternative to VI's, which isn't saying too much. I hope I'm wrong, but that's what I've made of it so far.
Thinking about my previous post more, I came to the idea as to why they may have excluded hourglass deformity from the criteria:
If a guy has hourglass deformity caused by plaque on multiple sides of the penis, then they can only inject the drug at one spot at a time.
So let's say they decide to inject it on the left side...If the drug breaks down collagen and the left side "fills out" more after that, then there would be a tendency to curve more on the right side where the drug wasn't injected. So that in itself may skew the results by inadvertantly causing more curvature, even though the total end result would be much better at a later date when they are able to inject at all areas of plaque. Also, I can understand how it would be difficult to measure improvement. How would they measure improvement in hourglass deformity? Is it girth measurement in that area? perhaps reduction of hinge effect? The easiest way to measure improvement is through curvature and that's what they want to achieve the best results in order to pass the FDA and get this drug to market in which they've invested so much money in, so I guess that makes sense.
I really like the idea of this drug as it may be our first step to a real cure. Think about it... All we have so far are treatments to either stretch scar tissue, or prevent it from spreading. A drug that can actually dissolve the Peyronies plaque would truly eliminate the disease. The other part of the equation would be to restore elastin which is much more difficult. If we can eventually have a treatment plan of xiaflex to dissolve the collagen, pentox to prevent further damage, and ved or traction to stretch the remaining tissue, then I truly believe that we can beat this disease. It does give me hope.
chefcasey: If the information contained in this document is correct, then I don't think restoration of elastin is a big issue:
http://www.patentstorm.us/patents/4338300/description.html
According to this document, collagenase does not break down elastin, but rather, it eliminates the cross-linked type I & III callogen so that the elastin is free to stretch.
In regard to ventral curves being excluded from the study, I suspect that ventral curves will also be excluded after the drug has been approved by the FDA. I think I read somewhere that the urethra and the surrounding corpus spongiosum is more vulnerable to the action of collagenase, and since the urethra is located on the bottom side of the penis it would be difficult to successfully deliver the drug into the plaque without risking degradation to surrounding structures. Maybe someone else can confirm this for sure, but I think that is what I read somewhere.
Quote from: MikeSmith0 on February 26, 2011, 05:46:19 PM
Quote from: bigk on February 21, 2011, 01:11:52 AM
I found the information regarding 90 degrees of bend per 60 mm plaque at this link: http://peyronies.org/pages/mechanics.htm.
And I found the information regarding a 2mm radius from the injection site at this link: http://www.patentstorm.us/patents/4338300/description.html
I took some time to read the Auxilium phase IIb results, and it looks like the average angle of improvement was a little less than 6 degrees per injection cycle. So a 10 degree improvement per injection cycle is definitely on the high side, but certainly not out of the realm of possibilities.
When collagenase is used for duputren's, they inject nearly all of the medicine into a very localized area in the cord, and even after doing that, they still have to work pretty hard to "snap" the cord. So it kind of makes sense that using it for Peyronie's will require multiple injections due to the large volume of plaque that has to be dissolved and/or softened.
wow you are a great cyber sleuth. I can't believe I never found this in all my Peyronies Disease research! Thanks so much for posting this. I don't understand much of it at all... but it's interesting. Where does it say how much plaque is dissolved per injection? It is so confusing to me what they freeze dried, what was human, what was animal, etc...very complicated...and not scanned in well (the punctuation and words are mushed together sometimes)
Interesting to note that the drug targets the plaque more than the tunica (did you read that in there too... I could have mis read it) -- that's really quite important & i am surprised my doctor didn't mention that.
I suggest that you re-read this document several times. I've read it several times, and each time I find something new that was previously missed.
Quote from: rd on February 27, 2011, 10:11:13 AM
Mike the first thing I had done when I went to see my general uro was go get a mri after he examined me. He said everything looked fine from what he could see. Now they didn't just mri my unit, they did my whole mid section with focus on it. But he couldn't see anything wrong.
Oh that's interesting...MRIs are strange. They pick up some things and not others - but I was pretty sure they would allow the radiologist to tell the difference between scar tissue and normal tissue. Maybe a 3T MRI (higher power and resolution) would be better? Then again, if the thing was just read by a radiologist (who probably never sees Peyronies Disease) he might not have spotted it the same way they would've spotted a brain tumor. Did you see the images too? I would like an MRI to to vertical slice images of the entire penis so I can see where the plaque is, where the calcification is, and then make a more informed decision about surgery or continuing in the xiaflex trial for the real drug after the placebo trial ends. But also ,laying in that tube I would not exactly have a large flaccid penis... I think you'd need something to stretch it in order to get the images you want.
BTW guys, you only get like 2 cc of xiaflex for 4k. So, they are limited in what they inject once it goes on the market too. The DC patients have the same issue. If you have a semi-circle plaque, it might not be possible to inject the whole thing with enough xiaflex in one sitting...depends on the size, thickness, etc... might cost a lot of money to go after a more complex plaque. You'll need repeat injections regardless - but w/ multiple plaques covering a large area... 2 cc (of a total 0.58 mg) is very little.
They don't want to inject the underside bc of the urethra. Not sure when it hits the market if docs will do this off label... sounds potentially dangerous. My doctor said he felt it could be done (they can avoid the urethra w/ this needle), but Auxilium made the decision not to do it...perhaps their insurance company made this decision for them. Who knows.
BigK:
Thanks for the link. Wow that is a lot of information to digest. I was under that the impression that normal tunica is composed of 5% elastin. Once there is a wound and scar tissue forms, it replaces it with less elastin and more of the types of collagen that you described. I'm just not quite sure that once the drug gets rid of those bad types of collagen, whether or not elastin is restored by the body like it was pre-scarring.
Yea I had thought about the potential for injury to the urethra. However, there is a lot of tissue on the ventral side that should steer clear of the urethra as it runs through the corpus spongiousum in the center. Either way I suppose it depends on the effectiveness of the drug in clinical trials and the discretion of your physician injecting the drug. Do they avoid ventral plaques for VI's too?
Chefcasey- Ive had the Vis with a ventral plaque underneath right by my urethra. I also had hypospadia from birth and a good 50% of my urethra was surgically built over three reconstructive surgeries. My urethra is not exactly ran where it was suppose to be naturally and the docs still did the injections with no problems. I had 12 injections too.
That's good to know woodman:
I'm not sure if they're worried about just the needle puncturing the urethra or maybe it's because the difference in the drugs. Perhaps maybe it's the collagenase that may spread and dissolve around the spongiousm and that's what they're concerned about. Either way, if we're not in the trials we're at least a year away before the drug hits the market if approved, so it's not a concern of mine at the moment, just a thought.
A quick note to say that Xiapex (EU Name for Xiaflex) today was granted European approval for use in treatment for Dupuytrens Contracture:
http://www.tmcnet.com/usubmit/2011/02/28/5343218.htm
When was it approved for use in the United States, I thought that happened like a year ago? Does anyone know?
This forum could probably be merged with the other one, I think we could definitely condense the forum down a little.
Wow, this sounds painful and not fun! Best of luck to you matthew, keep us updated on your success or lack of success!
Comebackid
Yea I think it was last Feb ...
I have been doing my modeling and the inside of the shaft near the plaques is always sensative. It doesn't hurt all the time unless I bump something or shake after peeing. All the color has returned to normal in the shaft but the sack is still bruised. My pelvic region is still sensative to the touch also, not sure what causes it but it is getting better. It has been three weeks today that I got my first injection of the first cycle. I can still see quite a bit of curvature however in the past when I got an erection my head remained soft and unchanged but now it swells like the rest! It does feel good to see some improvements. I go in on the 28th of this month for my measurements and next cycle of injections. After the swelling that I got from my first cycle, that is not something that I am looking forward to.
Hope this doesn't sound weird, but I'm glad your glans swelled too! Finally some sort of good news. I have the same issue with my glans.
Quote from: Mathewfamily on March 07, 2011, 04:15:36 PM
I have been doing my modeling and the inside of the shaft near the plaques is always sensative. It doesn't hurt all the time unless I bump something or shake after peeing. All the color has returned to normal in the shaft but the sack is still bruised. My pelvic region is still sensative to the touch also, not sure what causes it but it is getting better. It has been three weeks today that I got my first injection of the first cycle. I can still see quite a bit of curvature however in the past when I got an erection my head remained soft and unchanged but now it swells like the rest! It does feel good to see some improvements. I go in on the 28th of this month for my measurements and next cycle of injections. After the swelling that I got from my first cycle, that is not something that I am looking forward to.
Matthew,
Glad to hear you're feeling better but it seems like it took much longer than "normal" to get there. I know each person can react differently. Mine took 2-3 days for the swelling to go away. Also of some concern is the continued sensitivity and the fact that it is so far from the injection site. I hope your Dr can explain it.
Going back to Feb when you had your first two shots, you said the Dr "tightly wrapped your penis in gauze" and you had some extreme swelling. That would be a major concern of mine and a serious point to discuss with him next visit. No one here has ever mentioned that happening before as best I can remember. After he removes the needle, my Dr holds a small piece of gauze on the injection site for about 2 minutes and I hold it for 3 more minutes. I'd like to hear what others experienced in this situation during the Phase 2 or 3 trials.
I hope you have much better luck in your next series of shots.
Humorous
Is anyone else having the sensativity in the pelvic region just above the base? My bruising went up into this region about 4-5 inches.
It has gotten a lot better but I was just curious if any one else had this.
for the people having bruising, are you seeing any results in curve, girth, or general size?
i have had no bruising or results and assume i am getting the placebo
I actually had bruising for the first time in my cycle three injections. Not sure if that means anything or not. I'm not seeing a significant change in shape or curvature, though I also don't have that many erections to check. I'll let you know on my next evaluation scheduled the second week of April. Also haven't experienced any sensitivity in the pelvic region.
Let me tell you about bruising/swelling, my shaft was over three times the normal girth and the color of an eggplant with red swatches on it. I took pics for my nurse and doc and they were quite amazed at the reaction. I could scare little old ladies with these pics. The skin was so stretched it shined and I just kept poking at it just to make sure there was a little more room to swell because I was worried it would rupture my skin. Once the swelling started to go down my skin itched so bad trying to heal. I sure hope the same results do not happen in three weeks.
Quote from: Mathewfamily on March 09, 2011, 02:57:22 PM
Let me tell you about bruising/swelling, my shaft was over three times the normal girth and the color of an eggplant with red swatches on it. I took pics for my nurse and doc and they were quite amazed at the reaction. I could scare little old ladies with these pics. The skin was so stretched it shined and I just kept poking at it just to make sure there was a little more room to swell because I was worried it would rupture my skin. Once the swelling started to go down my skin itched so bad trying to heal. I sure hope the same results do not happen in three weeks.
That's pretty crazy. It's interesting that the dupuytren's contracture patients report very similar experiences from their xiaflex injections. I am sure it's a lot less scary in the hand than the penis - but at least you know you are not in the placebo condition. This is the reaction people should have to xiaflex in this trial -- though yours is probably on the extreme end.
Did you at least see any results in your plaque, curve, dents, or size from this? ED? Did you have hourglassing, size loss, or any narrowing - or just a curve?
I had bad bruising and swelling from verapamil so i can relate to that. I am not having any effect from the xiaflex, so I guess the silver lining for you is that you're not wasting a year of your life in the placebo condition like me (while it continues to worsen). And then waiting another 1+ year for the real drug.
http://www.news-medical.net/news/20110309/Auxilium-completes-patient-enrollment-in-XIAFLEX-phase-III-trial-against-Peyronies-disease.aspx
for the guys in the trials:
What do they tell you to do as far as having erections/sexual activity? Are you supposed to abstain for a certain period of time? Or can you engage in it as soon as pain and swelling have gone down?
Also, I know you are supposed to do modeling by simply bending it when flaccid daily, so what would getting an erection do during this period? I imagine it would help break up the collagen by the erection stretching it.
Quote from: chefcasey on March 10, 2011, 09:51:07 PM
for the guys in the trials:
What do they tell you to do as far as having erections/sexual activity? Are you supposed to abstain for a certain period of time? Or can you engage in it as soon as pain and swelling have gone down?
Also, I know you are supposed to do modeling by simply bending it when flaccid daily, so what would getting an erection do during this period? I imagine it would help break up the collagen by the erection stretching it.
I was told two weeks usually; or sooner would be OK if signs of swelling and bruising had gone away and I felt comfortable trying.
Quote from: chefcasey on March 10, 2011, 09:51:07 PM
for the guys in the trials:
What do they tell you to do as far as having erections/sexual activity? Are you supposed to abstain for a certain period of time? Or can you engage in it as soon as pain and swelling have gone down?
Also, I know you are supposed to do modeling by simply bending it when flaccid daily, so what would getting an erection do during this period? I imagine it would help break up the collagen by the erection stretching it.
They don't tell you to abstain but when it's swollen, you definitely will! What they do say is you should be able to resume sexual activity within two weeks, meaning (to me) if you have swelling it should be gone within that time frame. If you don't swell or feel pain, you should be able to resume right away.
I was told that I could model either flaccid or erect. Of course, if you are younger and have a "rock hard" erection, I wouldn't think that's advisable.
Humorous
update:
I've recently completed my cycle 1 injections.
The first injection yielded nothing reaction-wise but tenderness at the injection point.
The second was totally different. After about 3 hours I began to bruise and swell pretty gradually with the swelling peaking about 10-12 hrs post injection. Most of the swelling for some reason is/was around the base although the plaque being injected is on the top about halfway down.
Afterwards (about 2-3 days) most of the swelling went away, but the bruising continued and could be seen spreading into parts of my scrotum. The bruising was dark and all along the sides of the shaft as well. Anyone know if the bruising is caused by the drug travelling to other plaqued areas? Or is it just antibody reaction in the blood vessels?
The reaction to the second injection would suggest to me that I received the drug, but since about 5% of placebo participants had a reaction in the past trial, I think I'll wait and see till the next cycle is complete till I get any hopes up!
If some of those that had the placebo last time had reactions, then I'm guessing there's something in it that creates antibodies, or causes an allergic reaction? Anyone have more info on what's actually in the placebo?
Thanks,
BSSS
Quote from: ronners on January 29, 2011, 06:57:37 PM
@Tim468
I hear ya - it's just a few of the guys here have commented below on the difference in appearance and consistency of the study drug they have been given - as well as their body's reaction to the drug / placebo ... It's quite an intrusive study given the amount of injections involved so I think the info is relevant ...
I have also heard that there is likely to be upcoming Xiaflex (AA4500) trials in the UK ... I am meeting my Uro in March so will post details as and when I have them
Will keep my eyes peeled for any news. I gave up on my GP / consultant as their opinion was surgery or "live with it".
I am in the open label study and have recently completed the 1st cycle - 2nd injection. On the underside of the penis, near the head, there is what I can best describe as either a small amount of reddish blue skin or it could be a small sack of blood that looks real ugly. it does not hurt , but is real sensitive. I spoke to both the urologist and physicians assistant and both said this reaction was normal and will go away in due time. Have any of you had the same reaction?
Also, it has been 10 days since the end of the cycle and there is still considerable swelling, but it has gone done some. Have you had the same experience?
sorry, i should have said SAGGING, reddish blue skin
i never had any negative reaction... not a good sign
MikeSmith0:
If you would like to complain about the stupidity of having a placebo group for these trials, you can do so by going to this link:
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplaintsrelatingtoClinicaltrials/default.htm
I doubt it will really do much good to complain, but it can't hurt either. If nothing else, you will at least have the satisfaction of telling the "authorities" that they are a bunch of idiots.
Thank you Big K. I don't think that anything i would have to say would make a difference. In situations like this, being ignored is worse than not complaining at all. I know I am not the only one who feels this way though...based on people I've talked to on PM who don't post as much. I could drop out of the trial at any time, go back on traction, pentox, etc... it's not like they even had that much success in phase 2, per their own website. A 25% (not 25 degree) change is decent...but if 25% is all they got, traction and VED (with oral meds) has given better results than that.
Quote from: Mathewfamily on March 08, 2011, 02:30:05 PM
Is anyone else having the sensativity in the pelvic region just above the base? My bruising went up into this region about 4-5 inches.
It has gotten a lot better but I was just curious if any one else had this.
yes, I had the bruising above but not that much sensitivity.
My bruising, or whatever it was looked more like blood under the surface/or had the look of a blood blister just under the skin's surface. I had this coupled with some pretty serious swelling (esp around the base) that went away after 4-5 days.
all you guys in the phase III trial might want to ask your clinic about the 'open label' follow up if you receive the placebo in phase III. From the looks of it Auxillium is currently recruiting 250 subjects by invitation only to participate in the open label study and the one they are recruiting for now is only open to the phase II participants it appears. The open label part currently being recruited for ends 03-2012. I have no idea if Auxillium intends to do anymore open label studies, but it might be worth asking about....esp if you think you are currently receiving the placebo.
Of course, I could be reading it all wrong, but the info I saw was on the govtrials website.
http://www.clinicaltrials.gov/ct2/show/NCT01243411?cond=%22Peyronie%27s+Disease%22&rank=4 (http://www.clinicaltrials.gov/ct2/show/NCT01243411?cond=%22Peyronie%27s+Disease%22&rank=4)
BSSS
BSSS,
For our members who don't know much about medical terms, what is an open label study?
Comebackid
CBK,
Don't know the total definition, but it means the study isn't blinded; that everyone knows what's being injected.....in this particular Auxillium study what's being injected is the drug, Xiaflex. So, if you're chosen, you no doubt receive the drug, basically.
Hope that helps.
BSSS
Cycle 4, shot 1. As usual, the shot went well. This is the next to last shot.
There's good news and bad news concerning the measurements, which is after three cycles of Xiaflex injections (18 weeks). The bad news is there was no change in the angle so I'm still at 35 degrees. Since I started at 60 degrees, my decrease is 25 degrees. However, the good news is flaccid length has increased by 2cm which is 13/16 inch. That seems pretty good, but I've nothing to compare it to.
I know Mike would like to know about any changes in girth since that has been a concern of his. While I can't say for sure it's increased, since I never measured it before, I do believe in has increased.
I'd like the others in the study to post their "End of Cycle 2/3/4" measurements in the same way. (The nurse has these measurements. By using her data the results will be more "scientific".) Indicate start degrees, end of Cycle x degrees, total change, plus change in flaccid length. (Please keep in mind the end of Cycle 3 is the beginning of Cycle 4.) It would be interesting to see if there is a correlation between degree change and increased length. In my case the change would seem to be slightly less than 1mm per degree.
I expect to post shot two results tomorrow.
Humorous
Humorous3: As I recall you had indicated that you gained 10% for each of the previoius two cycles, and if that's true, then you did at least gain another 5% with the 3rd cycle. If these numbers are correct, then you are least moving in the right direction. In regard to the flacid length, your gain of 2 cm is just about right. A 90 degree bend is equal to 6 cm of plaque, and so proportionally, a 25 degree change in bend should equal about 1.7 cm. I have not read it anywhere, but I would bet that the penile structure is capable of at least doubling in length when stretched. Whatever that number is, it would be important piece of information for judging and quantifying your 2 cm gain in length.
I think you're still moving in the right direction, but it's becoming obvious that a starting angle of 60 degrees will require more than 4 injecection cycles. More than likely, you will need at least 6 injection cycles to reach the most optimum end point, and if any of the cycles happen to be administered with a "less than optimal" injection technique or location, then you could possibly need 7 or 8 cycles.
It wouldn't surprise me if Auxillium came out with a "new drug" that is essentially the same formula as Xiaflex, but with a different name. That way they could employ a different pricing scheme that would keep the overall cost down to something more reasonable. If you were to use the prices currently charged for dupuytren's injections, then the total cost could easily be more than $50k. They seem to have extremely tight control of their distribution channels, so I don't think there would be any danger that the hand doctors might start ordering the cheaper drug intended for Peyronie's. But all of this is conjecture on my part... who knows what they will end up doing. But one thing is for sure, insurance companies are not going to shell out $50k so that we can get a beautiful hard-on and avoid a lifetime of anti-depressants and therapy.
The men who post on this thread, all report some improvement. Are there any forum readers who have not seen any improvement so we can get a more realistic view of Xiaflex. Even Auxillium does not claim 100% success.
Mike Smith and Chopsuey have reported that they have received no 'signficant' improvement despite early signs of success.
This seems to be down to the difficulty the researchers face in 'measuring' imrpovements in an organ which has a shape that is variable to changes in temperature / blood flow etc. It would appear that measurements are taken in the flaccid state too ...
Humourous has seen a 41% improvement in curvature and an improvement in length and he is 3/4 of the way through the trial. The reactions to the drug he has experienced and the results would point towards the assumption that he is recieving the real thing.
In total Auxilium are going for approx 750 open and closed study participants - on this forum we have 4-5 posting their experiences so we know we can't be that objective ...
I have to say that I am encouraged to read about Humourous's results as it would suggest the drug really can alter the the structure of the underlying tissues that cause this condition, something that vitamins, electric shocks and stitches are unable to do ...
thanks for the update Humourous and good luck with your last few shots - can I ask how you and the other the participants feel about the amount of injections involved?? Having read about posters on this forum who have claimed problems as a result of injections it has got me thinking - I wouldn't have an issue with the pain involved but I would be worried that I might be causing more damage .... what are your experiences with the multiple caverject injections as well as the xiaflex shots and what are your thoughts about this in general as you move towards the end of the trial ..??
Quote from: Humorous3 on March 30, 2011, 02:07:04 AM
However, the good news is flaccid length has increased by 2cm which is 13/16 inch. That seems pretty good, but I've nothing to compare it to.
I know Mike would like to know about any changes in girth since that has been a concern of his. While I can't say for sure it's increased, since I never measured it before, I do believe in has increased.
Thanks for the info humorous. Did the flaccid length translate into the same amount of erect length too? I've noticed changes in my flaccid length in the past (during the traction era) that did not affect erect length. (I'm talking about flaccid, stretched length). That's interesting if girth was increased...did you have a narrowed area along with the curve? Is your plaque just on top?
Ronners, yeah chopsuey and i have not seen changes but 1/3 are in the placebo group...so its not really a comparison yet.
Have just completed third cycle and have shown no improvement in angle or length. Also, none of the injections have caused any bruising whatsoever. Either I'm getting the placebo or I'm immune to the medication.
Quote from: bigk on March 30, 2011, 09:10:43 AM
Humorous3: As I recall you had indicated that you gained 10% for each of the previoius two cycles, and if that's true, then you did at least gain another 5% with the 3rd cycle. If these numbers are correct, then you are least moving in the right direction. In regard to the flacid length, your gain of 2 cm is just about right. A 90 degree bend is equal to 6 cm of plaque, and so proportionally, a 25 degree change in bend should equal about 1.7 cm. I have not read it anywhere, but I would bet that the penile structure is capable of at least doubling in length when stretched. Whatever that number is, it would be important piece of information for judging and quantifying your 2 cm gain in length.
I think you're still moving in the right direction, but it's becoming obvious that a starting angle of 60 degrees will require more than 4 injecection cycles. More than likely, you will need at least 6 injection cycles to reach the most optimum end point, and if any of the cycles happen to be administered with a "less than optimal" injection technique or location, then you could possibly need 7 or 8 cycles.
It wouldn't surprise me if Auxillium came out with a "new drug" that is essentially the same formula as Xiaflex, but with a different name. That way they could employ a different pricing scheme that would keep the overall cost down to something more reasonable. If you were to use the prices currently charged for dupuytren's injections, then the total cost could easily be more than $50k. They seem to have extremely tight control of their distribution channels, so I don't think there would be any danger that the hand doctors might start ordering the cheaper drug intended for Peyronie's. But all of this is conjecture on my part... who knows what they will end up doing. But one thing is for sure, insurance companies are not going to shell out $50k so that we can get a beautiful hard-on and avoid a lifetime of anti-depressants and therapy.
bigk,
Actually it was 10 degrees (not %). You are correct about the "additional" 5 degrees. Good catch and here is the explanation. They take three degree measurements at the initial screening when they do the Doppler, etc. Mine were 50, 55, and 60. I have been using 55 degrees in my postings because I considered it as an "average". Plus, the nurse said I had 10 degree improvements twice (at end of Cycles 1 and 2) and I am at 35 degrees. Maybe I can get an explanation from her. Or, since measuring the curve is a bit less exact than measuring a straight line, we can just say it crept in such as 2.5 degrees each of those two times.
Yes, I agree that four cycles/eight injections aren't enough to "get straight". Let's see what the Cycle 4 results are in about six weeks. And, for this example, let's assume I get 10 degrees as I did in the first two cycles. That would be a 35 degree change and put me at 20-25 degrees. During this study Auxilium will stop giving injections when someone reaches a 15 degree angle. So, I agree with your theory that it might take 5-6 injection cycles to reach 0-15 degrees (or maybe more) depending on the individual and the Doctor's skill at "hitting' the plaque.
Your "new drug" idea is an interesting one and I hope they do something to lower the cost as others have projected here in the forum. Somewhere, many months ago, I remember reading that Auxilium would price Xiaflex slightly above or below the cost of surgery. That makes sense to me as I think insurance would be more likely to pay for injections over surgery if the costs of both are similar.
Humorous
There are two other items about this study that I haven't seen mentioned here before.
1. The Xiaflex dosage strength is different (higher) for those with a 60 degree or greater curve. (I don't know whether it's 2x, 3x, or whatever.) On page 4, para 2, the study paperwork says "at a dose of 0.58mg".
2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient. That is $12,500 per injection. I don't think this will have any bearing on the retail price.
For the others in this study, feel free to confirm this.
Humorous
Well, I've had shot 2 of Cycle 4, which is my last Xiaflex injection. My body's reaction was much better this time as compared to after any previous shot 2 reaction. Swelling and discoloration was only moderate - no purple eggplant with severe swelling (75-100%) and no blood blisters as I had after some earlier injections (always after shot 2).
The next thing for me is to look forward to the measurements in about six weeks.
Humorous
Quote from: Humorous3 on March 31, 2011, 01:22:44 PM
There are two other items about this study that I haven't seen mentioned here before.
1. The Xiaflex dosage strength is different (higher) for those with a 60 degree or greater curve. (I don't know whether it's 2x, 3x, or whatever.) On page 4, para 2, the study paperwork says "at a dose of 0.58mg".
2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient. That is $12,500 per injection. I don't think this will have any bearing on the retail price.
For the others in this study, feel free to confirm this.
Humorous
I don't think I can afford this drug, if it ever is approved. Yikes!
Quote from: Humorous3 on March 31, 2011, 01:22:44 PM
There are two other items about this study that I haven't seen mentioned here before.
1. The Xiaflex dosage strength is different (higher) for those with a 60 degree or greater curve. (I don't know whether it's 2x, 3x, or whatever.) On page 4, para 2, the study paperwork says "at a dose of 0.58mg".
2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient. That is $12,500 per injection. I don't think this will have any bearing on the retail price.
For the others in this study, feel free to confirm this.
Humorous
Good catch regarding my errant use of the "%" symbol vs. "degrees". In regard to your reference to the "study paperwork", I would very much like to read it. Is this something that you have on paper, or is it available somewhere online? If you only have a paper copy, I would be grateful if you could somehow send me a scanned copy. The more technical the paper, the more I would be interested in reading it.
In regard to your reference to 0.58 mg of collagenase, this is the same amount that they use for Dupuytren's injections. With Dupuytren's, the vial starts out with 0.9 mg of collagenase, which is then reconstituted with 0.39 ml of solution. And from the 0.39 ml of solution, the Doctor draws out 0.25 ml of solution. So if 0.25 ml is drawn from the vial containing 0.39 ml, then you are essentially drawing out 64% of the collaganase that was in the vial (0.25/0.39 equals 0.64). And if you calculate 64% of the original 0.9mg that was available in the vial, the result is 0.58mg. So I think you are getting the exact same dose that they use for Dupuytren's.
Quote from: restore on March 31, 2011, 06:39:48 PM
Quote from: Humorous3 on March 31, 2011, 01:22:44 PM
There are two other items about this study that I haven't seen mentioned here before.
1. The Xiaflex dosage strength is different (higher) for those with a 60 degree or greater curve. (I don't know whether it's 2x, 3x, or whatever.) On page 4, para 2, the study paperwork says "at a dose of 0.58mg".
2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient. That is $12,500 per injection. I don't think this will have any bearing on the retail price.
For the others in this study, feel free to confirm this.
Humorous
I don't think I can afford this drug, if it ever is approved. Yikes!
I think it will be much less expensive depending on how widely the drug gains acceptance if approved. My guess is that if it does, all Peyronies Disease specialists will begin to use it as they've been following it very closely. It may take some time for general urologists to come through after that. The official % of people with Peyronies Disease is anywhere from 1-10% of men, but most Peyronies Disease specialists believe it to be in the 9-10% range, although we don't know exactly what % of men actually seek treatment due to this being an embarrassing subject. Nevertheless, even by the most conservative estimates, it should be in the millions of men that seek treatment in the U.S. and obviously much more if other countries are included. With these large numbers, the company would benefit from huge economies of scale to regain their initial investment and reducing production costs if it becomes a viable treatment, and thus bringing the cost to us and the insurance companies way down. The insurance companies will get on board too if the price drops far enough to where it is a cheaper option than surgery, which from what I've read can be anywhere from 40-100k.
The real issue is how well it performs in the trial. If it doesn't do so well, it will probably just be a slightly better option than the old verapamil injections and won't be widely used. Let's just hope for the sake of our penises and wallets that it does perform well and gains worldwide acceptance and usage.
I totally agree. Where is the point for Pfizer to craft a drug that nobody can affrod ? If Xiaflex can improve our condition it will be a blockbuster in term of sales.
The main question is : is it efficient ? The money matter (at least for me) is not the main problem.
I'm sure they've already done the math, finding the amount of sales for a breakeven point etc. I believe it's already approved for the hand contracture, and that's less common then Peyronies Disease, so I assume there's some big bucks to be made with us.
" 2. The cost of the Phase 3 study drug, as priced by Auxilium, is around $100,000 per patient. That is $12,500 per injection. I don't think this will have any bearing on the retail price. "
Are you sure it is the study drug ? This doesn't make sense since it is on the open retail market for 4000 per vial already. That would be 36k per patient - retail. The retail dose is the same as the dose on the study information sheet (0.58 mg).
If you add in the doctor's fees, coordination costs, blood tests, trimix injections, insurance, patient reimbursement, etc... the cost of this study is probably 100,000 per patient. But, the drug itself is not any more than 8k per cycle and that's retail. And that was when it came out - it might have dropped a little... I originally saw those numbers a while back on the Dupuytren's board. It could've gone down in price if people weren't having good results with 1 or 2 treatments and needed more (or risk docs starting to abandon it).
It'll be like 3-4k per injection... 6-8k per cycle. You can get it now for that if you had Dupuytren's. They might even lower it more if this trial shows a big difference with the guys who had 4 cycles (last trial only had 3) for results...or insurance might cut you off after 4 cycles. Plus doctors & their pharmacies will mark it up like any injectable drug. Depending on your doc, you'll have a visit fee and/or facility fee.
Ben, it has already been shown to be effective - but they only studied 3 cycles...and the effects were about 25% of the curve reduced, which isn't great...and I'd love to know if the scar comes back too a year later...or if it heals properly the second time around.
Mike,
I think we're comparing apples and oranges here. The cost of the study drug is an internal accounting matter while the retail price is totally different. I understand they have priced it for Dupuytren's but maybe they computed the study drug cost like a car prototype - extremely expensive. Or, as you mention, maybe they are including the total study costs. The only reason I mentioned it was because it seemed so extraordinarily high. And, I did add that I didn't think it would have anything to do with the retail price.
Do we have any accountants on the board that could shed some light on this?
Humorous
Note to all:
Adding my 2 cents about the cost of any product that is presented to the public for use. At one time, I was the chief purchasing agent for a large aircraft engine manufacturer in the U.S. When we produced a new engine to the market, all costs from whatever source in the company were gathered by our accounting and pricing department to be included into the retail price for the market.
So, bottom line, any and all costs all the way from the individual parts of the engine, engineering time, production time, trials and testing time along with shipping and handling were included in the market price.
Therefore, all costs whatever source relating to the product are included into the sales price of the end product. In the case of a medication, when it is administered by a doctor or a hospital, even these costs are added to the bill when presented to the patient. So, that is why Xiaflex is costing so much on the first presentation to the public. As time goes on and the amount of distribution continues, the cost may or may not go down based on the quantity being produced and sold.
Old Man
This is all disheartening. From all the discussions, and everything I've read so far, this drug is not a cure. And if I will eventually be asked to pay $100K for the full round of treatments, at least for me, it would have to be a cure.
That said, I realize my Peyronie's is still in the acute phase with minor bend, I may feel differently if the disease progresses further.
Quote from: restore on April 02, 2011, 11:34:33 AM
This is all disheartening. From all the discussions, and everything I've read so far, this drug is not a cure. And if I will eventually be asked to pay $100K for the full round of treatments, at least for me, it would have to be a cure.
That said, I realize my Peyronie's is still in the acute phase with minor bend, I may feel differently if the disease progresses further.
I think it's "not a cure" because they are not using enough injection cycles. If you were to start out with an angle of 30 degrees, then Xiaflex could probably provide a "cure". But if you start out with a 90 degree angle, then the chances that you can be "cured" with four injection cycles are slim to none. Right now I'm somewhere around 38 degrees, so I'm hopeful that I really can be "cured" with this drug.
Guys ...
Why would a drugs company try to sell a treatment for 100,000 dollars when surgery costs a tenth of the price ...?? for any product to succeed it needs to be sensibly priced within its market place ...
Why would you be limited to 4 injection cycles when more might help further ..?? The answer is that this is a trial and it is simply designed to get the drug approved by the relevant authorities around the world so that the drug can be shown to be safe and effective and then marketed and sold by auxilium and pfizer ...
The price will come down. It is like anything! When the xbox first went on sale it cost £350. Now you can get them for £129 with a few games attached. It is also about supply. The more you produce the cheaper it is to make. The more you sell the easier it is to make profit so you can lower the price. The more a hospital buys the better a deal they can bargain with.
Quote from: Worried Guy on April 02, 2011, 02:47:33 PM
The price will come down. It is like anything! When the xbox first went on sale it cost £350. Now you can get them for £129 with a few games attached. It is also about supply. The more you produce the cheaper it is to make. The more you sell the easier it is to make profit so you can lower the price. The more a hospital buys the better a deal they can bargain with.
What I dont understand is I thought xiaflex allready existed and is approved and is used for dupuy contractions.
If a I had dupuy, a doctor could give me a xiaflex injections treatment (i read somewhere it is about 5000,-$)
Up to now I thought the xiaflex trials are to see if it also works for Peyronies.
Am I wrong? And is it a different xiaflex used for peyronies than for dupuys contractions?
Luc
Quote from: Luciano on April 02, 2011, 05:08:47 PM
Quote from: Worried Guy on April 02, 2011, 02:47:33 PM
The price will come down. It is like anything! When the xbox first went on sale it cost £350. Now you can get them for £129 with a few games attached. It is also about supply. The more you produce the cheaper it is to make. The more you sell the easier it is to make profit so you can lower the price. The more a hospital buys the better a deal they can bargain with.
What I dont understand is I thought xiaflex allready existed and is approved and is used for dupuy contractions.
If a I had dupuy, a doctor could give me a xiaflex injections treatment (i read somewhere it is about 5000,-$)
Up to now I thought the xiaflex trials are to see if it also works for Peyronies.
Am I wrong? And is it a different xiaflex used for peyronies than for dupuys contractions?
Luc
The formula being used for Peyronie's is identical to the one approved for Dupuytren's. But with Dupuytren's, the Doctor actually snaps or breaks the weakened cord, which is not an option for Peyronie's. With Peyronie's they are trying to "dossolve" (for lack of a better word) the plaque, which requires quite a few more injections.
Quote from: bigk on April 02, 2011, 05:23:58 PM
The formula being used for Peyronie's is identical to the one approved for Dupuytren's. But with Dupuytren's, the Doctor actually snaps or breaks the weakened cord, which is not an option for Peyronie's. With Peyronie's they are trying to "dossolve" (for lack of a better word) the plaque, which requires quite a few more injections.
Thanks for the info
but then the pricing should be clear.. and be the same on a per/injection (at same dosage) base.
I meen if 15 x 20 cc injections are used for dupuytrens and cost 5000$
I would suspect if 4 series of 15 injections are used for peyronies then the cost would be 20000$
(these are just examples as I dont know exactly how many are needed for dupuytrens, but I meen they will have to make a price similar on a cc/concentration base, and cant suddenly jump to 100k$)
L.
Note to all:
According to my hand surgeon who did my DC surgery in 2009, a two injection ampule of Xiaflex used for DC would cost him around $3,000.00. Adding his office visit and administration costs to that, he would charge about $3,500.00 for the two shots.
So, using that as a base (if these figures are correct) one can figure an approximate cost of what the injections for Peyronies Disease would cost. However, nobody seems to know how injections would be necessary to "treat/cure" Peyronies Disease.
Old Man
All of the calculations and assumptions about costs that people are making on this thread are derived from costs associated with the treatment of dupuytrens contracture ...
However, as several have tried to point out already, this really doesn't mean that xiaflex for the treatment of peyronie's will be priced the same way ... There are already differences in terms of branding (Xiaflex is marketed as Xiapex in Europe for the treatment of DC) and there are different healthcare systems in place all over the world (i.e. not everyone uses private insurance to pay for treatments).
Simply and logically, for a product to sell, it has to be priced competetively and be affordable regardless of whether it's insurance companies, governments or individuals that are paying for it ... some of the costs projections on this thread in my opinion are unrealistic and unfounded
Quote from: ronners on April 02, 2011, 08:13:45 PM
All of the calculations and assumptions about costs that people are making on this thread are derived from costs associated with the treatment of dupuytrens contracture ...
However, as several have tried to point out already, this really doesn't mean that xiaflex for the treatment of peyronie's will be priced the same way ... There are already differences in terms of branding (Xiaflex is marketed as Xiapex in Europe for the treatment of DC) and there are different healthcare systems in place all over the world (i.e. not everyone uses private insurance to pay for treatments).
Simply and logically, for a product to sell, it has to be priced competetively and be affordable regardless of whether it's insurance companies, governments or individuals that are paying for it ... some of the costs projections on this thread in my opinion are unrealistic and unfounded
I can't think of any drugs that have 2 separate FDA approvals that are priced differently for each indication. I think it would be a problem for the entire distribution channel to say "these are the Peyronies Disease bottles - and you have to charge X for them -- and these are the DC bottles - and you have to charge X+$1000 for them". Is that even legal to do? It seems shady. Urologists would just have their orthopedic surgeon friends order them cheaper vials or vice versa... they wouldn't even get in trouble for it once it is FDA approved.
I know viagra is approved for a heart condition... and it goes under a different name -- but I don't think this affects the price. It does affect how some insurance plans cover the drug though.
You're right about the R & D costs Mike. Plus the fact that most other countries set price ceilings on treatments that make the profit margins really thin, so the only way they can recoup the costs is by charging higher prices to the americans. It may suck for us, but without it, the profit motive for R & D wouldn't be there and we would not have as many drugs as we have today. The initial fixed costs such as R & D, plant and lab facilities and machinery are always quite high in pharmaceuticals because of just like you said, it's extremely difficult to get drugs to market. If these trials do well and xiaflex becomes part of the new "gold standard" of Peyronies Disease treatment, then increased production will most likely lower the average cost of production per unit of the drug. So during the trials, if the avg. cost is 100k, then by having it produced in mass it may be somewhere around 50-60k for all the cycles, assuming the usage rights don't change and no one else produces it. It wouldn't be priced differently than the kind used for DC, but DC is even rarer than Peyronies Disease, so adding this new demand for the drug would increase production significantly.
The insurance companies here in the U.S. will look at it statistically like anything else...i.e what is the % of patients that will ultimately need surgery times the avg. cost of surgery etc., and how much the use of xiaflex reduces that to calculate what they'll cover. Now I've heard of people having grafting surgery with Dr. Levine, where the cost to the patient is anywhere from to 5-15k, and the bill he sends to the insurance company being 40k. That being said, the insurance companies may cover a very good portion of it.
QuoteI can't think of any drugs that have 2 separate FDA approvals that are priced differently for each indication. I think it would be a problem for the entire distribution channel to say "these are the Peyronies Disease bottles - and you have to charge X for them -- and these are the DC bottles - and you have to charge X+$1000 for them". Is that even legal to do? It seems shady. Urologists would just have their orthopedic surgeon friends order them cheaper vials or vice versa... they wouldn't even get in trouble for it once it is FDA approved.
I know viagra is approved for a heart condition... and it goes under a different name -- but I don't think this affects the price. It does affect how some insurance plans cover the drug though.
Auxilium and Partners have a right to sell the drug to whom and how they want ... The Distribution channels on their website seem very tight and what you are describing above about urologists selling their vials to hand surgeons and vice versa is illegal here in the UK (I'm unaware of how it works in the US) ... I'm not so sure that specialist urologists and orthopedic hand surgeons would look to be arbitraging vials of xiaflex between each other on a grand scale to exploit price differentials and it would appear that the distribution network that Auxilium has in place would make this difficult ...
Here is just one example of a drug that is looking at different pricing strategies for different indications -
http://medikol.co.uk/mediKOL%20Brief%205...ing_Sept%2009.pdf
This article is interesting as the principles are similar - the conclusion at the end comes back to affordability ... Drugs are also priced differently in different countries ... It is my opinion that if Xiaflex is priced at the level of some of the estimates on this thread then it becomes intrinsically unaffordable - If it is unaffordable in the US where the income per head is at one of the highest levels in the developed world then it will definitely be unaffordable elsewhere. This doesn't make commercial sense from a business perspective - it's my opinion that you will see a different pricing structure for different indications.
It i still a very new drug. It was only approved for Dupuytren's use in early 2010. Most individual hospitals in the UK have not even approved it yet let alone started to use it. Pfizer whilst stating at the moment that it should not be used for peyronie's will be very pleased if it could open up a new market for them. They will not let this opportunity pass. I'm confident if this stuff works we will be seeing it on the NHS in the next 5 years. I was told by my Uro that I just missed out on the UK trial by a few weeks. His words were "Don't worry, if it is a successful trial the chances are you can have it after"
well my 2 cents..... I would think if anything that the drug - at least at first - would be priced a little higher for peyronie's just from the simple fact that it has to be profitable for shareholders, especially if it's true (as someone mentioned earlier) that there are more peyronie's sufferers than DC sufferers. If there's one thing true about drug companies in the US, it's that the drug will be priced high to start with due to demand.
Ronners, the US healthcare system is a giant mess which does not work under any logical or capitalist principles.
For example, medicare just approved payment for men with late-stage terminal prostate cancer that will give them 4 months longer to live - for $93,000. Simultaneously, medicare is restricting more and more of what they will cover that is not anywhere near as expensive.. but they approved this. Of course that is a life or death issue but 93k is a pretty big price tag for 4 months. And, it's free if you are over 65 (medicare is government health insurance all Americans get over 65). However, needing 15k surgery might get turned down for no reason.
Pricing here is not made for people, unless something is over the counter. When Claritin went over the counter, they did worse for a while, because Zyrtec (its competitor) was still RX. So, you either paid $20 for Claritin or a much cheaper amount for (insurance covered) zyrtec - assuming your co-pay was under $20. In the USA, if you have MS, CF, HIV, or Cancer, you will have an annual drug bill of $30,000 a year...(or more). Insurance pays... unless you don't have insurance then you're fairly screwd & can sometimes work with public aid or with the drug companies...but that's hit or miss. I have no idea how it works in the UK. The point is - drug companies can get away with outrageous prices all they want. Doctors hands are not tied at all when it comes to off-label drugs, but if a drug company has tight distribution channels, then things change. I have no idea how they stock & ship xiaflex or if there are intermediaries, wholesalers, etc... there are drugs on the market that have similarly restrictive distribution channels...usually these are for 1 indication though.
I have no idea what the system is like in the UK...but based on what you said - there's a lot more leniency here for docs to do a lot of things - particularly outside of managed care environments (in private practice). I saw the link but I have never seen something like that here. I don't work in healthcare though so I dont know.
Well I can only go form what my Uro told me. Under the labour party, at the start of their leadership, we had a postcode lottery where basically you got differing treatment depending on where you lived within England and Wales. This has all changed as you can now choose which doctor and which hospital you want to visit anywhere in the country. You go to your GP and tell him where you want to go. He then looks on the system and gives you a password. You then go home and call the national centre and they arrange an appointment which best suits you. My first appointment took 2 weeks and was at a private hospital paid for by the NHS in the closest city to me. I was not that pleased with the outcome and went back to my GP for another password and booked an appointment in London at UCLH with the UK's leading peyronie's team. I then had to wait 6 weeks. Had a very good service whilst I was there. I was told that I had just missed out on the Xiaflex trial but not to worry if it was a success I would likely get it after. I was told that my Uro carried out the UK VED study and that VED could stop it getting worse and even improve the situation. I was referred to the VED clinic they have their to start VED and was told I will probably not have to pay for the VED equipment. All this was free (paid for by our higher tax system) Just waiting for my VED appointment.
Oh and 6 weeks of pentox cost me £7.40 with my prescription. If I was in Scotland, Wales or NI it woud have been free. That is annoying but £7.40 is not that much.
Thanks for the info mike and worried guy - I guess we'll just have to wait and see - If approved, Pfizer owns the rights to sell the drug in the UK and Europe so maybe there will be differences in the manner and price at which the two companies operate at ... There are certainly some big differences in our healthcare systems as pointed out by mike ..
Auxilium has priced the xiaflex treatment for Dupuytren's at a level that, on average, is the same or just below the costs of surgery for the condition (about 5400 dollars is the average that they expect a dupuytrens patient to pay) ... Importantly they made a point of stating this when the drug was approved and they were starting to sell it - At the very least this indicates that the company realises that the price of their treatment has to be based upon the treatments that are currently available to patients. However, in the case of Peyronie's the cost and type of surgery can vary dramatically so it will be interesting to see what, if any, benchmark they use ...
One thing I feel for certain is that if the drug is approved it will be available a lot sooner in the US that in the UK / Europe ... In the US, Xiaflex was granted approval in FEB 2010 for Dupuytrens and launched a short while later - In Europe it was only granted approval last month and Pfizer intend to start marketing the drug in the second half of the year!! This is despite the approval applications going in at roughly the same time ...
can't a guy just jab a needle full of ganregnous enzymes into his dick anymore without having to wait around for years on end!! I mean jeez ..!!
I guess they will have to recoup R&D costs and once they have done that can sell it cheaper. I would imagine it will be in the USA before the UK. The NHS is facing some pretty major cuts which is a fear of mine. Pfizer are actually closing their UK plant making 2400 unemployed directly and god knows how many indirectly. These are tough times. Lets hope there is enough in the kitty for us peyronie's sufferers.
Is there anyone on this forum who is in the open label study. If so, would you please tell me how long before your side effects of Xiaflex injections such as swelling, redness etc. resolved and the appearence returned to normal.
Thank you.
Quote from: ronners on April 04, 2011, 02:57:21 PM
can't a guy just jab a needle full of ganregnous enzymes into his dick anymore without having to wait around for years on end!! I mean jeez ..!!
lol
If you left the UK, do they pay for anything to be treated in the USA? My insurance doesn't pay for anything outside the USA unless it is an emergency, then there's some process they have to pay back the country / hospital / doctor involved. But, i couldn't go to a consult in any other country w/ my insurance. I don't even know if I could see a doc in London for cash, could I? Let's say you were the ones who developed / approved the drug. Is it 100% controlled by the government - or can you see a doc for a fee that you pay?
I'm new to forum and been just been reading about Xiaflex. I think one thing the UK users haven't really factored in regarding xiaflex is economies of scale. Xiaflex may cost $5000 ect (matching surgery) in the US were the heathcare system is fragmented by many (comparitively) small buyers. But with the NHS's huge purchase capacity (one of its main advantages) it highly likely the NHS Confederation could negotiate a significant discount. They potentially could bring the price down to say 20% or 30% below the average parity cost of surgery. If that turns out to be the case, then Xiaflex will be cheaper alternative and make surgery largely obsolete. Since the NHS is always hungery for savings, getting Xiaflex to patients may end being a high priority.
Chipped you are probably right! The NHS employs 1.7 million people and has a budget of £110 billion (the same size as Chile or Czech Republics whole economy) they should be able to strike a bargain.
Mike, I believe only in very special cases the NHS will pay for you abroad. I believe you can pay for healthcare if you are from another county but it could be a fair wack!
Quote from: ohjb1 on April 04, 2011, 06:07:52 PM
Is there anyone on this forum who is in the open label study. If so, would you please tell me how long before your side effects of Xiaflex injections such as swelling, redness etc. resolved and the appearence returned to normal.
Thank you.
Ohjb,
If you are referring to the US open label study, I believe that will not begin until after the current Phase 3 study ends which is late this year (for me) and maybe next spring for others.
However, addressing your question of side effects, look at earlier posts in this forum by me and several others who are in the Phase 3 study. There are 4-5 of us posting the results of every cycle. (A cycle is six weeks long.) To give you an idea of how far back to go, my first post for Cycle 1 injections and the results/side effects was posted Nov 28, 10. In addition to my posts, other posts to look for are from BSSS, ChopSuey, Matthewfamily, and MikeSmith. (If I've left anyone off, please make an additional post.) Hope this helps.
Humorous
Is there a link where you are posting your results together? I would like to know how you guys are getting on!
Quote from: Worried Guy on April 05, 2011, 01:53:36 PM
Is there a link where you are posting your results together? I would like to know how you guys are getting on!
Worried Guy,
This thread is where we are posting. (Re-read the title.) You just have to go back (down the pages(s)). Look at my last post (the one you responded to) for a starting point and names to look for.
Humorous
Sorry Humorous3, I should have looked back. Thought there might have been a condensed page like there is for VED and progression in general. I guess it is a little early to create one of those. Sounds like you have had pretty good results so far!! Lets hope it continues with your next shot.
Quote from: Humorous3 on April 05, 2011, 01:49:29 PM
Quote from: ohjb1 on April 04, 2011, 06:07:52 PM
Is there anyone on this forum who is in the open label study. If so, would you please tell me how long before your side effects of Xiaflex injections such as swelling, redness etc. resolved and the appearence returned to normal.
Thank you.
Ohjb,
If you are referring to the US open label study, I believe that will not begin until after the current Phase 3 study ends which is late this year (for me) and maybe next spring for others.
However, addressing your question of side effects, look at earlier posts in this forum by me and several others who are in the Phase 3 study. There are 4-5 of us posting the results of every cycle. (A cycle is six weeks long.) To give you an idea of how far back to go, my first post for Cycle 1 injections and the results/side effects was posted Nov 28, 10. In addition to my posts, other posts to look for are from BSSS, ChopSuey, Matthewfamily, and MikeSmith. (If I've left anyone off, please make an additional post.) Hope this helps.
Humorous
Humurous,
Looks like they may be already recruiting for the open label study and it appears it may be included in phase three of the trials?
http://clinicaltrials.gov/ct2/show/NCT01243411?term=peyronie%27s&rank=1 (http://clinicaltrials.gov/ct2/show/NCT01243411?term=peyronie%27s&rank=1)
Says 300 participants and it looks 'international' I saw one study recently that indicated it was invitation only, so I'm wondering if Auxillium has changed the study requirements?
Re: Xiaflex
« Reply #273 on: Today at 05:08:30 PM »
--------------------------------------------------------------------------------
I posted this on the Xiaflex thread and wanted to post it here as well. Hope it's not too confusing. I quoted myself there to share new info:
not yet.....I've been through the first series of injections. I also didn't notice much if any change erect. I don't have a compass to measure angle, but at first glance it appears about the same.
I definitely do not have the hinge effect although I was concerned about modeling the first few days.
I do want to follow up this post with some notice of a change. I've seen some difference in my angle when erect. I didn't at first but the angle is less sharp, or more gradually curved. I really couldn't put a number on it at this point and the info is anecdotal of course, but none the less encouraging. I did round one of injections several weeks ago and have been pretty good about remembering the modeling.
BSSS
:)
Hello fellow trial participants!
I live in Sydney, Australia where the trial has just commenced. I have completed Cycle 1 last week and already can see an improvement from the measured baseline of 50 degrees to about 30 degrees currently. The swelling took about 4 days to subside and the purple bruising a few days longer. I'm inclined to think I am in the active drug group, although i know that placebo effects can also be convincing (deluding is perhaps a better word)! I guess the truth will be revealed on measurement day at the commencement of Cycle 2. Apparently placebo effects are greater for treatments that are more costly to the participant in terms of things like inconvenience and discomfort, as well as things like credibility. Judging from my experience, this trial scores pretty high on all these factors.
My thanks to the initiator of this forum, and to previous contributors - it's good to know what others are experiencing and thinking....
Taurian
Quote from: taurian on April 05, 2011, 07:55:20 PM
:)
Hello fellow trial participants!
I live in Sydney, Australia where the trial has just commenced. I have completed Cycle 1 last week and already can see an improvement from the measured baseline of 50 degrees to about 30 degrees currently. The swelling took about 4 days to subside and the purple bruising a few days longer. I'm inclined to think I am in the active drug group, although i know that placebo effects can also be convincing (deluding is perhaps a better word)! I guess the truth will be revealed on measurement day at the commencement of Cycle 2. Apparently placebo effects are greater for treatments that are more costly to the participant in terms of things like inconvenience and discomfort, as well as things like credibility. Judging from my experience, this trial scores pretty high on all these factors.
My thanks to the initiator of this forum, and to previous contributors - it's good to know what others are experiencing and thinking....
Taurian
I have a question about how they measure the angle. I have a plaque located on the top, and a digital photograph taken from the side shows the angle to be different on the top (concave) side vs. the bottom (convex) side. The angle on the top side is always the largest of the two, and conversely, the angle on the bottom is the smallest. It would seem reasonable to simply average the top and bottom angles, but I'm wondering if the doctors are only using one of the two angle measurements?
Quote from: Humorous3 on April 05, 2011, 01:49:29 PM
Quote from: ohjb1 on April 04, 2011, 06:07:52 PM
Is there anyone on this forum who is in the open label study. If so, would you please tell me how long before your side effects of Xiaflex injections such as swelling, redness etc. resolved and the appearence returned to normal.
Thank you.
Ohjb,
If you are referring to the US open label study, I believe that will not begin until after the current Phase 3 study ends which is late this year (for me) and maybe next spring for others.
He's in the open label study now bc he got the placebo in phase 2. very small group of guys in this group. he had 3 cycles of the placebo.
Quote from: taurian on April 05, 2011, 07:55:20 PM
:)
Hello fellow trial participants!
I live in Sydney, Australia where the trial has just commenced. I have completed Cycle 1 last week and already can see an improvement from the measured baseline of 50 degrees to about 30 degrees currently. The swelling took about 4 days to subside and the purple bruising a few days longer. I'm inclined to think I am in the active drug group, although i know that placebo effects can also be convincing (deluding is perhaps a better word)! I guess the truth will be revealed on measurement day at the commencement of Cycle 2. Apparently placebo effects are greater for treatments that are more costly to the participant in terms of things like inconvenience and discomfort, as well as things like credibility. Judging from my experience, this trial scores pretty high on all these factors.
My thanks to the initiator of this forum, and to previous contributors - it's good to know what others are experiencing and thinking....
Taurian
Sounds great Taurian, good luck to you, hope you have continued success!
Hmm, good question...I didn't register how this was done, I was looking at the ceiling at the time! The Dr used a special metal instrument and I think it was applied to the top angle. he certainly didn't carry out any calculation, unless he did it mentally. The dorsal angle is sharper than the ventral angle, and probably easier to measure. I'll pay more attention next time (next month) and will ask what the protocol is..
[/quote]
I have a question about how they measure the angle. I have a plaque located on the top, and a digital photograph taken from the side shows the angle to be different on the top (concave) side vs. the bottom (convex) side. The angle on the top side is always the largest of the two, and conversely, the angle on the bottom is the smallest. It would seem reasonable to simply average the top and bottom angles, but I'm wondering if the doctors are only using one of the two angle measurements?
[/quote]
Quote from: bigk on April 05, 2011, 10:43:17 PM
I have a question about how they measure the angle. I have a plaque located on the top, and a digital photograph taken from the side shows the angle to be different on the top (concave) side vs. the bottom (convex) side. The angle on the top side is always the largest of the two, and conversely, the angle on the bottom is the smallest. It would seem reasonable to simply average the top and bottom angles, but I'm wondering if the doctors are only using one of the two angle measurements?
bigk,
The following quote from the study consent form may or may not fully answer your question.
"The study doctor will measure the severity of the curvature of your penis using a small device placed on the surface of the penis, called a goniometer (a ruler that measures angles), which allows the study doctor to measure the degree of curvature in your penis." Then it goes on to mention injecting a drug to create an erection.
From my observation, it is placed on the "inside" of the angle between the top and middle of the penis. This would seem to "average" the angle. Another thing is they don't have to induce a "full" erection to get an accurate measurement. This benefits the patient as it lessens the time it takes to get flaccid again. The doctor must wait until then to inject the Xiaflex.
Humorous
Quote from: Humorous3 on April 07, 2011, 12:32:47 PM
Quote from: bigk on April 05, 2011, 10:43:17 PM
I have a question about how they measure the angle. I have a plaque located on the top, and a digital photograph taken from the side shows the angle to be different on the top (concave) side vs. the bottom (convex) side. The angle on the top side is always the largest of the two, and conversely, the angle on the bottom is the smallest. It would seem reasonable to simply average the top and bottom angles, but I'm wondering if the doctors are only using one of the two angle measurements?
bigk,
The following quote from the study consent form may or may not fully answer your question.
"The study doctor will measure the severity of the curvature of your penis using a small device placed on the surface of the penis, called a goniometer (a ruler that measures angles), which allows the study doctor to measure the degree of curvature in your penis." Then it goes on to mention injecting a drug to create an erection.
From my observation, it is placed on the "inside" of the angle between the top and middle of the penis. This would seem to "average" the angle. Another thing is they don't have to induce a "full" erection to get an accurate measurement. This benefits the patient as it lessens the time it takes to get flaccid again. The doctor must wait until then to inject the Xiaflex.
Humorous
Humorous,
Why do you think the dr. has to inject when flacid? Any idea? What would be the problem with injecting while erect?
BSSS
BSSS i think it easier to target the plaque on a flacid penis (maybe there is another reason).
Does a Xiaflex trial volonteer with curve enhancement seen improvement in sensation ? with Ed quality ? with lenght and girth ?
By the way I think that the different result may be linked to the % of medecine involved. When a chemical lab test a pill, they use different dosage to evaluate the minimal dose to have an effect and the maximal dose after which unwanted effects are too frequent.
So some men may receive Xiaflex without any improvement while other men on Xiaflex may have huge swelling and bruising.
- I wish to thanks every man involved in those trials, may your efforts be rewarded-
Quote from: BSSS on April 07, 2011, 04:49:27 PM
Humorous,
Why do you think the dr. has to inject when flacid? Any idea? What would be the problem with injecting while erect?
BSSS
BSSS,
I believe it's because the Dr. has to feel the plaque and get the location before injecting. I think it would be difficult to find the plaque when erect. Also, and this is just a guess, I think there would be a greater internal bleeding problem if he injected while erect.
Humorous
Hi Everyone,
Just finished my cycle three evaluations and there has been no improvement. I'm convinced that I am getting the placebo. I haven't seen any bruising or swelling and haven't had any improvement. Just received my 2 forth cycle injections, which seemed to hurt more than usual. Maybe because I think they're the placebo and aren't doing me any good? I'm grateful to be in the study, but it's difficult to go through when you're part of the 1/3 placebo group and you know you have to do the whole thing again once you finish phase three. If it's definitely the placebo, I won't see the real drug until the beginning of next year.
I really sucks that you're probably getting the placebo, but considering that you have had zero improvement, I suppose it would be in all of our best interest if you really are getting the placebo. Thanks for the update, and let's hope that the future will be far better than the present.
The guys on the UK study seem to have some pretty bad swelling and bruising. It is a shame if you are getting the placebo but at least you will know better after the study what the likely outcome of your treatment will be.
If I was only taking a pill or putting on a topical cream, it wouldn't be so bad. But damn, it's a lot of injections. Between the blood work, the injections for getting you up then making you go down, then the meds...then you find out it's just a placebo. I'll be ok...I was just really hoping this was all gonna work out this year.
Quote from: Chopsuey on April 11, 2011, 02:15:28 PM
I won't see the real drug until the beginning of next year.
I don't think we will see the real drug until the summer - at the earliest. They won't be done with the regular Phase 3 study until March of 2012. Then they have to analyze the data, re-enroll all the study sites again, ship out all the products, etc... though the learning curve is passed from phase 3, so maybe it won't take as long. It's hard to know - but I don't think it will be before 1 year from now. It's just insane that we could've basically been done now... but we won't even
start for a year. I can't believe I got Peyronies Disease to begin with and ended up in the placebo group. <1% chance of both happening to the same person... amazing.
Glass half-empty or half-full guys? Some of us didn't even make it into the study. We are sitting on the sidelines, watching and waiting, sometimes impatiently.
Quote from: MikeSmith0 on April 12, 2011, 10:25:10 PM
Quote from: Chopsuey on April 11, 2011, 02:15:28 PM
I won't see the real drug until the beginning of next year.
It's just insane that we could've basically been done now... but we won't even start for a year. I can't believe I got Peyronies Disease to begin with and ended up in the placebo group. <1% chance of both happening to the same person... amazing.
Quote from: MikeSmith0 on April 12, 2011, 10:25:10 PM
Quote from: Chopsuey on April 11, 2011, 02:15:28 PM
I won't see the real drug until the beginning of next year.
I don't think we will see the real drug until the summer - at the earliest. They won't be done with the regular Phase 3 study until March of 2012. Then they have to analyze the data, re-enroll all the study sites again, ship out all the products, etc... though the learning curve is passed from phase 3, so maybe it won't take as long. It's hard to know - but I don't think it will be before 1 year from now. It's just insane that we could've basically been done now... but we won't even start for a year. I can't believe I got Peyronies Disease to begin with and ended up in the placebo group. <1% chance of both happening to the same person... amazing.
Don't want to sound like a broken record, but are you sure there will be another open label study after 03/2012? I know phase III officially ends then, but recruitment has already begun for an open label study, and it looks to possibly be a sub-segment of phase III from what I saw.
Quote from: BSSS on April 13, 2011, 03:10:06 PM
Don't want to sound like a broken record, but are you sure there will be another open label study after 03/2012? I know phase III officially ends then, but recruitment has already begun for an open label study, and it looks to possibly be a sub-segment of phase III from what I saw.
Recruitment for an open label study for people who had the placebo in Phase 2 was going on for a while. It is considered its own "study" for FDA purposes and you will see it on clinicaltrials.gov. That's not related to phase 3. People in phase 3 are not finished yet. The last patients were injected for the first time in March. It is a 1 year study. Therefore, the study ends in March of 2012. Participants in phase 3 have been told that they will get the real drug after the study ends which will be sometime after March of 2012.
Quote from: BrooksBro on April 13, 2011, 06:08:10 AM
Glass half-empty or half-full guys? Some of us didn't even make it into the study. We are sitting on the sidelines, watching and waiting, sometimes impatiently.
I would be frustrated to be in your position too.
The main difference is that I can't be on any treatments right now (for a full year + then for the open label study - you cannot be on anything). No traction, pentox, etc... so we are all giving this all up for 2 years, roughly. I personally have only gotten worse since I stopped pentox and traction. I have had no reaction to the injected substance in the study (no swelling) and no change in curve. Also, its like 14 penile injections and a total of 17 doctor visits - for nothing other than the promise that in a year from today (most likely June) - I can START to get the real drug. The FDA will probably have it on the open market shortly after that anyway. With good enough insurance, it wouldn't be that expensive & the doctors can target more areas once it is on the market - and you can use traction and pentox. In the trial, they can only target 1 area (one plaque) - and you can't take any drugs or use traction.
So, the placebo group lost more (time, hope, painful penile injections, disease progression) than people are giving them credit for.
Rather than seeing a positive outcome by now, we've seen nothing and will not see a positive outcome until December of 2012. What do I do between now and December of 2012? I can't do anything but watch it get worse. I
could take pentox and traction, etc...and they'd never know, in theory - but then if I happen to go under 30 degrees from all that, I'm excluded from the open label trial anyway...or I could just drop out entirely now. It's just a bad situation. I wouldn't care if I had a placebo pill - but I am getting like 14 shots in my dick... and some people get more if their erection doesn't go down or if they want to numb the area more ,etc. And it's been discussed on other threads that needles in the tunica are not the safest thing...unless they actually contain some kind of medicine.
It is really crap for you mike. When you do get the real thing that should help and once it is certified the insurance can pay for your other plaques to finish off the job. It will go quicker than you think. It seems like a long way off now but it will soon come around.
Does anyone know Doctors in the San Francisco Bay Area that are doing these xiaflex trials? I talked to my uro and he said that since xiaflex is FDA approved for DC that I might find a doc that would use it for Peyronies off lable. Anyone working this?
Not sure about that! I can imagine it costing a lot of money?
Quote from: Cisco Kid on April 13, 2011, 06:21:07 PM
Does anyone know Doctors in the San Francisco Bay Area that are doing these xiaflex trials? I talked to my uro and he said that since xiaflex is FDA approved for DC that I might find a doc that would use it for Peyronies off lable. Anyone working this?
The trial locations are on clinicaltrials.gov. They are finished enrolling people now since they reached their capacity. Urologists will not be able to purchase it for you since the distribution channel for the drug is controlled. It would also cost 5k per cycle, roughly, if you were able to buy it based on what OldMan's doc told him about purchasing it for Duputreyn's...it is not reimbursable by insurance since it is not FDA approved for peyronie's.
It sucks sitting around waiting for this drug ... I can imagine it also sucks if you're in the trials and getting the placebo ... but we are where we are ... I might be way off, but my understanding is that once phase 3 trials are over there are no further trials planned - placebo participants just get the real drug as and when and the results are released to the relevant authorities for consideration.
There are open label trials going on at the moment for individuals in the EU (UK included) and I think Australia and some in the US - This will be finished before or at the same time as the closed label study (i.e. March 2012) ...
In all honesty Mike, if I was you, I would resume your previous treatments for the time being. I think concerns about dropping below 30% curvature are unfounded and you will get the drug anyhow - and even if Auxilium refused, as you've stated, if the drug works it will be on the open market a short while later ... clearly doing something will make you feel better emotionally at least ...
On a different topic, back to pricing - Xiapex has just been launched in the UK for Dupuytrens:
http://www.pjonline.com/news/new_dupuytren's_contracture_therapy
according to this article it will be sold for £650 per vial ($1050) ... It's not clear to me if this is the price to the consumer but it does indicate that there could be different pricing structures between Auxilium and Pfizer for this drug given the cost of the drug to physicians in the US is $3250 per vial for dupuytrens currently.
That should give people hope that we will see an affordable and realistic pricing structure for this treatment depending on the country and healthcare systems in place as opposed to shelling out $50k - $100k as some on this thread have suggested.
Lastly, in case people aren't aware there are some interesting reports coming back from guys in the open label UK trial about improvements / side effects / concerns etc. Worth a read ...
Quote from: ronners on April 13, 2011, 06:51:39 PM
Lastly, in case people aren't aware there are some interesting reports coming back from guys in the open label UK trial about improvements / side effects / concerns etc. Worth a read ...
Really, where are these posted?
The pricing in the UK will probably be cheaper...like Canada... the government buying / negotiation power works in your favor. Though that is the extent of my international health system knowledge.
Are the open label trials in the EU and UK from phase 2 placebo patients? I don't understand why anyone would sign up for a randomized trial when there is an open label one available. In the USA, via clinicaltrials.gov, it's just very clear you cannot sign up for the open label trial (running now) w/o having been in phase 2.
Update: oh i see no placebo is being given in the UK...well i am forced to conclude the brutish have more common sense then? In the USA for some reason, the FDA believes that we can think the plaque away. That is truly amazing that one country's standards are in line with rational (and ethical) reasoning... and the USA is just typical FDA red tape nonsense...that a placebo is necessary even though there is no chance it will do anything based on 100s of years of Peyronies Disease research.
http://www.peyronies-disease.co.uk/2011/02/xiaflex.html
https://www.peyroniesforum.net/index.php/topic,1558.msg30734.html#msg30734
Quote from: Worried Guy on April 13, 2011, 07:06:48 PM
https://www.peyroniesforum.net/index.php/topic,1558.msg30734.html#msg30734
wow - that was scary to read, though it wasn't that different from my verapamil experience w/ the pain, swelling, and brusing. The doc doesn't pull that hard on the penis during modeling - in my case - he said there's a risk of hurting the tunica. Also the informed consent even says the modeling is "gently" done.
Well, i am definitely getting the placebo...after reading that reaction description.
I will be interested to read their updates for sure.
Quote from: MikeSmith0 on April 13, 2011, 05:28:25 PM
Quote from: BSSS on April 13, 2011, 03:10:06 PM
Don't want to sound like a broken record, but are you sure there will be another open label study after 03/2012? I know phase III officially ends then, but recruitment has already begun for an open label study, and it looks to possibly be a sub-segment of phase III from what I saw.
Recruitment for an open label study for people who had the placebo in Phase 2 was going on for a while. It is considered its own "study" for FDA purposes and you will see it on clinicaltrials.gov. That's not related to phase 3. People in phase 3 are not finished yet. The last patients were injected for the first time in March. It is a 1 year study. Therefore, the study ends in March of 2012. Participants in phase 3 have been told that they will get the real drug after the study ends which will be sometime after March of 2012.
well perhaps this link will explain it since I evidently didn't do a well enough job? :) I hope that there are more studies to follow, but can't help but wonder if Auxillium has changed its mind re: open label study? The open label study explained here clearly shows it's part of phase III. I hope that there will be another for those who are counting on it.
http://clinicaltrials.gov/ct2/show/NCT01243411?term=peyronie%27s&rank=1 (http://clinicaltrials.gov/ct2/show/NCT01243411?term=peyronie%27s&rank=1)
Quote from: BSSS on April 14, 2011, 10:56:19 AM
well perhaps this link will explain it since I evidently didn't do a well enough job? :) I hope that there are more studies to follow, but can't help but wonder if Auxillium has changed its mind re: open label study? The open label study explained here clearly shows it's part of phase III. I hope that there will be another for those who are counting on it.
http://clinicaltrials.gov/ct2/show/NCT01243411?term=peyronie%27s&rank=1 (http://clinicaltrials.gov/ct2/show/NCT01243411?term=peyronie%27s&rank=1)
This is very confusing...
"Study Start Date: November 2010"
Why does it say that? that was the start date of the people in phase 2 i believe...i dont see why theyd offer an open label study alongside a placebo controlled study -- someone would have to call one of these places to find out who is enrolling in these studies. its very confusing online.
"Subjects who receive placebo in a previous Auxilium-sponsored study may enroll in this study provided they continue to meet the eligibility requirements."
but it doesn't say "
only subjects who received a placebo" .... strange.
Quote from: MikeSmith0 on April 14, 2011, 08:22:21 PM
This is very confusing...
"Study Start Date: November 2010"
Why does it say that? that was the start date of the people in phase 2 i believe...i dont see why theyd offer an open label study alongside a placebo controlled study -- someone would have to call one of these places to find out who is enrolling in these studies. its very confusing online.
"Subjects who receive placebo in a previous Auxilium-sponsored study may enroll in this study provided they continue to meet the eligibility requirements."
but it doesn't say "only subjects who received a placebo" .... strange.
I recall reading that the participants in the phase III study are "eligible for any subsequent open label studies", but it is not a promise that absolutly no matter what the placebo group will eventually get the real thing. It might not be a bad idea to talk to your urologist and ask that he find out whether or not there really will be a follow-on open label study that you can participate in. I would make it clear to the urologist that you intend to drop out of the study if there is no promise of a follow-on open label study. If there is no promise that you will eventually be able to enroll in an open label study, then there would be no reason what-so-ever for you to complete the study. If they want good data with valid results for the placebo group, then they need to step up and promise that you will eventually get the real thing. And if they are unwilling to do that, then if it were me, I would be tempted to wave the middle finger and say "I'm done"!
Quote from: bigk on April 14, 2011, 09:42:45 PM
I recall reading that the participants in the phase III study are "eligible for any subsequent open label studies", but it is not a promise that absolutly no matter what the placebo group will eventually get the real thing. It might not be a bad idea to talk to your urologist and ask that he find out whether or not there really will be a follow-on open label study that you can participate in. I would make it clear to the urologist that you intend to drop out of the study if there is no promise of a follow-on open label study. If there is no promise that you will eventually be able to enroll in an open label study, then there would be no reason what-so-ever for you to complete the study. If they want good data with valid results for the placebo group, then they need to step up and promise that you will eventually get the real thing. And if they are unwilling to do that, then if it were me, I would be tempted to wave the middle finger and say "I'm done"!
I agree. It's not right at all - but they set it up so that if you no longer meet the criteria (develop an isolated hourglass, are not in a relationship, curve under 30 degrees, stop responding to trimix, develop calcifications) they will not let you in. Zero guarantee...despite the fact that all their freaking needles may cause more calcifications - and you spent 17 days of your life having your penis manipulated & placebo injected into it. They could care less... it's cheaper for them if you don't qualify for the open label drug study. They can also pull the plug on the whole thing if the results are bad. Patents let some drug companies be total pieces of sh*t. There is zero reason they should exclude anyone (unless there is a danger from xiaflex in a particular peron's case) from the open label study if they wasted a year of their time in the placebo...but they will, I am sure.
The urologist at the study center has no power in the situation. One person complaining to 1 doctor will do nothing except potentially get the patient excluded for being difficult. It's the classic "one person can't step on the tracks and stop a train" problem. The study has already been designed with great effort between AUX and the FDA...and now it's on the tracks.. going along.
To AUX's defense though, the reason that single people and gay people were excluded was bc the FDA made them do it. This was not their idea. The FDA really wants details about vaginal sex...I have no idea why. If any other part of your body were deformed, I don't see why you need to put it in a vagina to validate that it is doing better. (ok sorry i have a sick sense of humor rarely displayed here) but seriously... if you had some skin disease that required collagenase...and it was just a "cosmetic" disease really...is the FDA not going to approve it? Any of the rosacea or acne drugs that went through the FDA were purely for cosmetic purposes and insurance pays on all of these... so it baffles me that you have to have a regular vaginal sex partner to be in the study. Who knows what will be a year from now...especially with the sh*t peyronie's creates for one's sex life and relationship. Maybe I'll hire a hooker if things go south so I can stay in the study.
Why are you guy's assuming that Xiaflex for ex-placebo patients will have to be administered in a open label trial environment?? I can't recall reading or seeing this anywhere ... It seems pretty clear that the trials (open and closed label) have all started and will all finish in March 2012 ... If you are concerned about whether or not you will recieve Xiaflex as a placebo patient after March 2012 then I would suggest a simple email to the Auxilium contacts on the Trial's website might clear things up ... I would certainly be inclined to do this before pulling out of a trial ...
Quote from: ronners on April 15, 2011, 07:03:35 AM
Why are you guy's assuming that Xiaflex for ex-placebo patients will have to be administered in a open label trial environment?? I can't recall reading or seeing this anywhere ... It seems pretty clear that the trials (open and closed label) have all started and will all finish in March 2012 ... If you are concerned about whether or not you will recieve Xiaflex as a placebo patient after March 2012 then I would suggest a simple email to the Auxilium contacts on the Trial's website might clear things up ... I would certainly be inclined to do this before pulling out of a trial ...
I agree with your suggestion.
Quote from: ronners on April 15, 2011, 07:03:35 AM
Why are you guy's assuming that Xiaflex for ex-placebo patients will have to be administered in a open label trial environment?? I can't recall reading or seeing this anywhere ... It seems pretty clear that the trials (open and closed label) have all started and will all finish in March 2012 ... If you are concerned about whether or not you will recieve Xiaflex as a placebo patient after March 2012 then I would suggest a simple email to the Auxilium contacts on the Trial's website might clear things up ... I would certainly be inclined to do this before pulling out of a trial ...
It is written on the paper based informed consent... "if you receive a placebo in this study, you
may be eligible to receive AA4500 in a follow up study after the completion of this study" is the exact wording.
This doesn't mean the FDA will be waiting for this data. They might be - but it's not clear. They can probably go ahead and submit the FDA application all their data from March 2012 and the official end of phase 3... however, the additional 100~ guys who get the placebo will also ultimately go into the prescribing information in the end (65% experienced swelling, etc...) Also, it is again a "study" because the FDA will not have approved it yet... they can take a long time to approve things - and they can't just say it's a "freebie drug we're gonna give out" ... they have to do it under the provisions of a study (informed consent, not FDA approved, investigational drug, no promise of anything, etc..)
Also, the people who got the placebo in phase 2 had to re-qualify for the open label drug. They will not give it to anyone who doesn't meet the criteria. Maybe it'll be different for post-phase 3 open-label... who knows.
The phase 3 placebo guys are by far the most screwed group...they just opened an open label study of 300 men with NO placebo...concluding in 36 weeks (which is 3-4 months shorter than the placebo group). So, we have to waste more time, we don't get the real drug, and we MAY get the real drug in a year. I realize not qualifying at all is unfortunate but I am just comparing the people in the different studies.
Quotet is written on the paper based informed consent... "if you receive a placebo in this study, you may be eligible to receive AA4500 in a follow up study after the completion of this study" is the exact wording.
Ah ... fair! Thanks for clarifying - From reading previous posts it seemed that placebo participants were guaranteed the study drug post trial. Realistically if the drug works the drug company will want to bring it to market ASAP to generate revenue. I think we can all agree on that. This would not involve waiting another 6-12 months for another open label study to be completed.
QuoteAlso, it is again a "study" because the FDA will not have approved it yet... they can take a long time to approve things - and they can't just say it's a "freebie drug we're gonna give out" ... they have to do it under the provisions of a study (informed consent, not FDA approved, investigational drug, no promise of anything, etc..)
Do you know these things for sure? If I was you (i.e. convinced I was in Placebo group) I would be doing what I could to ascertain whether or not I would receive the xiaflex post trial. This would involve speaking to my urologist and the contacts at Auxilium. At least that you should give you some basis to make a decision to continue with the trial.
QuoteThe phase 3 placebo guys are by far the most screwed group...they just opened an open label study of 300 men with NO placebo...concluding in 36 weeks (which is 3-4 months shorter than the placebo group). So, we have to waste more time, we don't get the real drug, and we MAY get the real drug in a year. I realize not qualifying at all is unfortunate but I am just comparing the people in the different studies.
Mike, at the moment we are all screwed here ... That is why we go onto a website to post stories about our bent willies! There are approximately 80,000 men in the UK with Peyronie's ... I would hazard a guess that alot of those people are as unhappy about their condition as you and I. However,
only 10 have been allowed onto the open label London trial ... So at the moment you are certainly not on your own in missing out on a drug that might offer some relief. However, it is possible that you will have access to Xiaflex a lot sooner than the rest of us .. You should look at the bigger picture and appreciate that we are all screaming out for a solution here!
Quote from: ronners on April 15, 2011, 10:19:35 PM
If I was you (i.e. convinced I was in Placebo group) I would be doing what I could to ascertain whether or not I would receive the xiaflex post trial. This would involve speaking to my urologist and the contacts at Auxilium. At least that you should give you some basis to make a decision to continue with the trial.
I already asked everyone. They won't say anything concretely at this point. It's a year away. My doctor does not know the details and AUX is not providing details yet - either because they don't know or because they were told not to provide them. What is really amazing is that the open label trial application was processed in november of 2010 (per the website) but when I asked an AUX representative on the phone if there would ever be an open label trial, her response was "no - the FDA requires a placebo group". Either she lied, didn't understand the question, or didn't know... but even aside from that, the fact that the timing of the open label trial ended up right after everyone in the placebo study enrolled is more than convenient. I dont think honesty is high on the priority list there...and so I would not believe anything they say anyway. Until I am sitting in a room w/ a syringe of xiaflex, I will not believe that I am getting it. If I don't respond well to trimix in a year, have more calcification, develop an hourlglass, or whatever else... I am 99% sure they will exclude me from the study. I can't confirm this concern because they won't confirm it. They just have not published the exclusion criteria yet. However, they already did this with the phase 2 placebo subjects so I don't see why they'd change it now. With that group, it was a 36 week study (with the standard exclusion criteria) so at least I won't have to go through another full year...and will be done at the end of 2012 if all goes well. Given my luck this far, I don't foresee all going well.
well all these reasons/concerns about placebo vs open label, etc. are why I posted what I did. I'd rather be informed about what's going on and not be given some empty promise about getting the real thing. My second round of injections are coming up in the not too distant future and if I feel afterwards as if I am receiving the placebo, I think I'll have to have some definitive answers re: open label to continue.
For those of you not enrolled yet, it looks like one of the doctors participating and currently recruiting in the open label part of phase III is the well known Dr. Levine.
Sign up while you can!! :)
Quote from: BSSS on April 16, 2011, 01:07:10 AM
I'd rather be informed about what's going on and not be given some empty promise about getting the real thing. My second round of injections are coming up in the not too distant future and if I feel afterwards as if I am receiving the placebo, I think I'll have to have some definitive answers re: open label to continue.
Great - please post what you find out if you can get any information.
If you had no reaction to your first cycle, you're getting the placebo. It's 100% guaranteed to create swelling...as evidenced by xiaflex for duputreyn's prescribing information (100% have swelling) and by the UK open label guys...all had swelling - if not to the first shot than at least to the 2nd.
I think the urologists & nurses are counseled by Auxilium to deal with patients who suspect they are in the placebo group - to keep repeating the same line "well some people have swelling and some don't - and it doesn't even correlate to their curve reduction" verbatim. When something is a script, it becomes obvious (we're not dealing with trained actors). They know who the placebo patients are by reactions from cycle 2. "Double blind" would have to be "double blind-folded" for anyone to believe that the doctors don't know 100% who is getting placebo. They're not told by AUX but they know if someone penis doubles in size and turns red from swelling - that's not a placebo patient. Someone who has no reaction & never has curve reduction - well, let's take a wild guess.
Hi Chaps
I have been through the cycle of injections for the trial in Australia (Sydney) and now the first followup to check progress.
My results show an improvement in the bend by 8 degrees (with a starting angle of 50 degrees) so assume I am not getting the placebo.
No increase in length reported yet.
Start 2nd round of injections this week.
Thanks
Saramon
It's heartening to see positive results from people all over the world (UK, US, Australis etc). Of course all treatment types have their benefits, but to see improvements so fast really is very positive. Maybe future rounds of treatment will result in the curvature becoming almost unnoticable? Either that or new multi pronged treatment regimens will start to appear (xiaflex then ved/traction, with oral treatments throughout the whole process etc). Exciting times ahead. Keep posting guys!
Question for the guys in the study: How often and for how many weeks to you perform modeling after the 2nd injection?
Quote from: saramon on April 17, 2011, 09:19:12 PM
Hi Chaps
I have been through the cycle of injections for the trial in Australia (Sydney) and now the first followup to check progress.
My results show an improvement in the bend by 8 degrees (with a starting angle of 50 degrees) so assume I am not getting the placebo.
No increase in length reported yet.
Start 2nd round of injections this week.
Thanks
Saramon
Saramon,
Good to hear of your improvement. Did you have any reaction (swelling, bruising, etc.) to the first series of shots?
After this next series, please post your reaction to those shots also. Thanks and good luck.
By the way, I had similar results after my first series of shots. I started with a 60 degree curve and had a 10 degree improvement at the end of Phase 1/beginning of Phase 2.
Humorous
Quote from: bigk on April 18, 2011, 08:55:35 AM
Question for the guys in the study: How often and for how many weeks to you perform modeling after the 2nd injection?
bigk,
My understanding is we are supposed to start after the swelling goes away and do it until the next injection.
Humorous
Quote from: Humorous3 on April 18, 2011, 04:31:54 PM
Quote from: bigk on April 18, 2011, 08:55:35 AM
Question for the guys in the study: How often and for how many weeks to you perform modeling after the 2nd injection?
bigk,
My understanding is we are supposed to start after the swelling goes away and do it until the next injection.
Humorous
How many times per day do you perform modeling, and how many repetitions each time?
Hi Humorous
No swelling, just some minor bruising at the injection site, I get more bruising from the modelling.
Hi Bigk
Modelling done at least once per day (stretching when flaccid, bending against the curve when erect), I don't think you stop from here on until end of trial, the Doc wants me to do it at least 75% of the time.
Just some general observations:
During my modelling demo from the doc a snap was felt by him and me when he was bending against the curve, the plague appears to be broken in half which is what he expected as he described the injection as a chemical scalpel.
The curve is remeasured so that the next round of injections are placed at the next greatest point of curve.
I don't find the injections to bad but it tends to sting for a couple of minutes after.
The trial goes for 4 cycles with about 1 month between cycles plus some followup stuff later (haven't checked into this yet).
Thanks
Quote from: saramon on April 19, 2011, 12:03:26 AM
Hi Humorous
No swelling, just some minor bruising at the injection site, I get more bruising from the modelling.
Saramon,
Doesn't your modeling card say "
Gently stretch..."? and "
Gently attempt to straighten..."? I don't think gentle modeling should produce more bruising. You may want to check with the study nurse or doctor about that.
For your information, I have been through the first four cycles of the Phase 3 study which includes modeling.
Humorous
saramon, you are expected to bend your erection? I'm not sure I like the sound of that! Could this not cause another injury? Just gently I assume?
Your dick stretches on its own during the night. Regardless of any protocol.how much modeling can make a difference? You are already altered for now?
Fubar
Hi Worried Guy
Yes - it is bent against your erection but as Humorous states it is done gently.
I can say that I am far less "vigorous" than the Doctor was and the bruising occurred on the head of the penis so have adjusted my technique (he managed to snap the plaque during the first modelling demonstration).
Hi Fubar, I think the stretching is to "model" the reforming scare tissue to a more normal shape but will ask for more information about this tomorrow when I have my next session.
I did ask what replaces the dissolved scare tissue and his answer was "hopefully less scare tissue".
Quote from: ohno on April 20, 2011, 08:44:52 AM
Saramon - Are you saying that your doctor manipulated (bent) your penis while erect? If so, did they give you another shot of trimex? This does not sound right at all.
ohno,
It is proper to model/bend an erect penis. Here is what the Home Modeling Instruction sheet says: "If you obtain a spontaneous erection,
gently attempt to straighten the penis during spontaneous erections; hold for 30 seconds in a more straightened position, but not so forcefully as to produce any pain or discomfort."
Having done it during the Phase 3 study, it's not as bad as it sounds, so there's no need for papaverine/trimix, etc., IMO.
Humorous
2nd cycle completed which includes:
1. Remeasure curvature of erect penis
2. 2 rounds of injections (around .5 mils each)
3. 1 modelling session
Some bruising at the injection site was still visible the day after the injections.
I asked what the modelling was expected to achieve and the response was that the injections make the plague pliable so the modelling is to attempt to reshape the penis to a more normal shape. During this modelling you could experience plague rupture.
All modelling done by the doctor is in the flaccid state and is a little bit uncomfortable (both stretching and bending 3 x 30 seconds each).
I find the injections sting quite a bit and more uncomfortable than the erection injection.
Cycle 3 due first week of June.
I think that modelling is less dangerous and more efficient with a stretcher. The stretching force can be soft but within a few hours could for sure do the job.
I remember a friend was aggravated by a urologist who pulled his penis forcefully.
Handling a medium tension for one or two hours sounds wiser to me than do it manually.
Quote from: Ben on April 21, 2011, 07:14:52 AM
I think that modelling is less dangerous and more efficient with a stretcher. The stretching force can be soft but within a few hours could for sure do the job.
I remember a friend was aggravated by a urologist who pulled his penis forcefully.
Handling a medium tension for one or two hours sounds wiser to me than do it manually.
I guess they decide on a method in these studies and go with it. It's at least a positive sign that they realise that stretching can be useful. Maybe techniques will develop over time based on what works or doesn't work in conjunction with xiaflex. I'm quite pleased with the reports we're hearing so far. A year or so back, the rumblings seemed to suggest that xiaflex might not be all that useful, but now we're hearing some positiv stuff coming through, which is great. Keep the reports coming guys!
Hello saramon, so after your second cycle how are things looking? Any improvements?
Hi Worried Guy
I think there is some improvement but won't really know until the next set of measurements are taken (at the end of May).
I did ask if the doctor thought the treatment would be effective in my case and he was pretty definite and positive about an improvement, provided I was on the drug and not the placebo.
PS.. I spelt plaque as plague (dangers of spell checking without wearing glasses), sorry for any confusion
Just had my cycle 2 injections. Good bit of swelling after the first injection and to be honest, the 2nd injection hurt like hell.
Good news is that I had a minimum 5% improvement in angle (pretty modest IMO) and gained some length.
Hello BSSS
- If you suffer from venous leakage have you seen an ED improvement ?
- Is there a gain in sensivity considering the plaque is thinning, dissolving ?
- Does the pain subside after injection or does it last for hours (as caverject) ?
Thank you for sharing those encouraging results with us.
Was that 5% in total or from the 1st cycle. I guess you have modelling to come yet so the angle may decrease further!?
Quote from: Ben on April 27, 2011, 12:03:02 PM
Hello BSSS
- If you suffer from venous leakage have you seen an ED improvement ?
- Is there a gain in sensivity considering the plaque is thinning, dissolving ?
- Does the pain subside after injection or does it last for hours (as caverject) ?
Thank you for sharing those encouraging results with us.
No on ED, or at least I wasn't told after the original ultrasound/doppler there was a problem. I will say I've benefitted in the past from drugs like Viagra but think now looking back on it that I was not diagnosed properly. Since then I do androgel for low-T and don't seem to have problems with ED. As a sidenote, I think that my self perceived ED problems are related to a total lack of self confidence caused by Peyronie's.
I have not noticed any sensitivity changes, but that could be due to the location of the plaque, where there's not that much sensitivity anyway.
I don't have lingering pain although I do have soreness where the injections took place. Any soreness or discomfort from that usually disappear in 48 hrs max. The pain otherwise is usually gone right away.
Quote from: Worried Guy on April 27, 2011, 12:51:39 PM
Was that 5% in total or from the 1st cycle. I guess you have modelling to come yet so the angle may decrease further!?
in my case total and 1st cycle are the same. I should've mentioned that they measure before injections and the 5% was basically the improvement after the 1st cycle.
Yes so if you get another 5% on the second cycle that is ok. What degree curvature are you starting off with if you don't mind me asking? If it was say 50 degrees that would be a 5 degree decrease over 2 cycles. That is a lot of pain for 5 degrees but this is not to say you will get 5% on your second cycle as you may get more. Did they mention how other people had been doing?
5% or 5 degrees - its important when reporting? 5 degrees on a 30 degree curve is over 15% improvement. 5% on a 90 degree curve is less than 5 degree improvment.
They seem to do it in percentages as with the phase 2 trials. Their target was a 25% reduction in curvature and all but 1 man had equal to that or better. The other guy got 24%. So if you had a 50 degree curvature and had a 25% improvement that would be a reduction of 12.5 degrees. I'm guessing that may still leave you needing surgery with a 37.5 degree deformity. In reality once the drug is passed you could have more injections than the phase 2 trial provided. I think it was 3 cycles of 3 injections each time. The men started at 50.2 degrees on average. It does not say what the average reduction in angle was.
Some useless information for you chaps to ponder - To type degree sign º in windows use the key combination hold Alt key down and then +0186 on the number pad.
e.g. 52º
I also found the injection fairly painful, not from the needle but from the chemical causing a stinging sensation, the 2nd injection was worse than the first. The 2nd cycle of injections was also more painful than the first.
BSSS I agree that psychological and physical ED are intricated with Peyronies Disease. In my case the softer the scar is (with traction) the harder the erection is.
I wonder when scar tissue is loosen or even dissolved if the shape of the penis will change much because volume and shape of healthy tissue will basically stay the same. Maybe if the corpus cavernosae bound with the scar tissuewill be engorged again, maybe not. After a while without expanding properly it will turn into corporal fibrosis.
While touching it I feel plaque instead of health tissue, not health tissue plus plaque.
As for pain perception my theory is that with the original plaque amount it does not stings a lot, and when the plaque is thinning the underlying tissue may be more affected and more sensitive.
Quote from: Ben on April 28, 2011, 04:32:06 PM
BSSS I agree that psychological and physical ED are intricated with Peyronies Disease. In my case the softer the scar is (with traction) the harder the erection is.
I wonder when scar tissue is loosen or even dissolved if the shape of the penis will change much because volume and shape of healthy tissue will basically stay the same. Maybe if the corpus cavernosae bound with the scar tissuewill be engorged again, maybe not. After a while without expanding properly it will turn into corporal fibrosis.
While touching it I feel plaque instead of health tissue, not health tissue plus plaque.
As for pain perception my theory is that with the original plaque amount it does not stings a lot, and when the plaque is thinning the underlying tissue may be more affected and more sensitive.
no doubt Ben on the mind part of it.
Seems I created some confusion here with my report. I do plan to confirm what I was told, but after thinking about it a little more believe I was told I had an improvement of 5 degrees in curvature. I will find out and post for sure.....sorry for the mix up!
I've completed my Cycle 4 followup visit. I had a 10 degree change. The total is a 35 degree reduction (started at 60 - ended at 25 = 35). So, averaging that over four cycles, that's 9 degrees per cycle. Although I was pretty disappointed with a 0 degree improvement for Cycle 3 (probably because I was concerned that the next cycle would be the same), I am satisfied with the overall result.
It would be nice to get at least 10 more degrees though, which would put me at 15. (That is the point when they stop giving you injections if you are in the current study.) But, as things stand now, that is probably impossible because of the potentially extremely high cost of Xiaflex and with no guarantees of success when the shots are sold commercially in the next year or so.
Humorous
Thanks for the update. Did you have any hourglassing or reduction in girth? If so, has that improved? Or too early maybe.
Great news Humorous,
Glad to hear you improved that much, very impressive.
A 35 degree reduction is really amazing... it certainly gives me some hope. Thanks for the update.
Hi guys,
I am new to this site and saw a lot of xiaflex discussion. I guess I am one of the lucky ones I guess who got in the open label trial. I had my first shot - and within 2 hours, it was very red and swollen. Within 4, it was so black and blue to the point of being pure black in some areas. I have had a reaction like this. I had verapamil before, and it bruised, but not like this. I am not in any major pain. There is dicomfort and the skin feels a little raw. When I walk around - it feels like a rug burn, so I am just laying in bed right now. I read one guy's post who thought his skin was gonna burst...man this stuff is scary.
I don't know how on earth he can inject me again for the second shot of this cycle. The swelling has obscured my natural anatomy greatly.
I urinated ok. There is no issue with that so far. Any advice guys is greatly appreciated! I expected a bruise and some swelling but this is something unusual. I reacted within minutes and worsened over the hours. My vitals are all fine.
I removed the pic... i just don't want it out there indefinitely.
Hello, It is always good to hear from people on the trial be it good or bad aspects. This could be the treatment for peyronies, give it a years or so, and potentially millions of men may have to go through this. I remeber a gentlemen called mattewfamily describing exactly the same as you. He could not believe the entent of the swelling and thought that the skin may actually split because he was so swollen. But he put a pack of peas on it and left it and the next morning the swelling had gone down consderable and then after a day or two he was back to normal.
Posted by mattewfamily
"Well guys, I am officially a member of your club. Pretty harsh entry fee, the shots!
This past Monday about 1 PM I had my first shot. My plaque is towards the tip, centered and the PA entered the needle from the side straight in. The first shot was pretty painless. They wrapped it up so loose that it didn't stay on very long and was just a lump of gauze in my pants. The 1.5 hour drive home was uneventful, then I got home and showed my wife. By this time it was swollen the size of half a chicken egg on the right side only and just starting to get red, this was about 5:30 PM. By 9:30 PM the shaft doubled in size from normal pretty much all the way around and it was very red with splotches of purple. The odd thing was the head was normal in color and size?!? Tuesday the swelling had gone down about half way but the colors were more even between the red and purple. By Weds. morning, the day of the second shot, the selling was almost all gone but the deep purple was more so than the red. My second shot happened at almost 2 PM. This shot hurt bad, burned like a hot knife that lasted about 3 to 5 mins. This time the doctor thought they should wrap the gauze a little tighter. The ride home was uneventful however when I got out of the car and walk four steps my knees hit the ground. It felt like someone was cutting it off right where the plaque is, it was the gauze wrap. I barely got in the house and down the stairs to get scissors to cut the wrap off. The swelling had no where to go so the base was big and swollen and the skin just under the head was swelling fast. Once I got the wrap cut off the swelling went crazy, especially the skin just under the head towards the underside. It looked like the frogs that blow up the underside of the jaw. The swelling was so bad I really was afraid the skin would rupture but it did not, Thank God. Lots of frozen corn and peas with Advil and Benedril. I woke up this morning to less swelling but still pretty severe. The bruising has now turned to an eggplant purple. The skin is SO sensitive that just walking is very uncomfortable. I really didn't think that it would be this bad but in the end, if it works, it will have been worth it. I am only 36 and I have a lot of lovin' to give to my wife"
"Let me tell you about bruising/swelling, my shaft was over three times the normal girth and the color of an eggplant with red swatches on it. I took pics for my nurse and doc and they were quite amazed at the reaction. I could scare little old ladies with these pics. The skin was so stretched it shined and I just kept poking at it just to make sure there was a little more room to swell because I was worried it would rupture my skin. Once the swelling started to go down my skin itched so bad trying to heal. I sure hope the same results do not happen in three weeks."
He has not been on here for a while but you may want to try and message him.
Worried Guy, thanks so much for posting that. Those descriptions are incredibly similar to mine. At the moment I am starting to worry that the black areas are going to break open. They are forming little tunnels in my skin and they are very thin. The nurse said "you may have water blisters" or something like that...so again I guess it's normal - just pretty scary to see happening vs. reading on a consent form or hearing from a nurse. I think mattewfamily is probably right on par with me... my skin is gonna take a long time to heal from this... it's really unusually bad.
Hi,
WFX from the UK open label trial...
Those pictures look pretty normal from what I can see. My penis went deep purple and nearly tripled in size from swelling. The swelling goes down reasonably quickly and takes around 4 days. The bruising takes around 7-10 days to go. It is very disturbing the first time it happens but you get used to it. I found that taking a warm bath really helped with any pain, bruising and swelling - as did taking diclofenac. Thanks for posting the pictures. We could really get a Frankenstein penis comp going on here with these injections. I hope you see good results.
WFX - Thanks so much for your thoughts. Sounds like things are normal for me then...Do you recommend ice after injections? I have ice here but I think the old time "rule" is - ice for the first day and warm thereafter. I am not sure I remember entirely. And, below, I posted a concern about ice harming the enzyme (not sure if it is a valid concern, but who knows).
What is weird about my swelling are the crevices because I was nervous and my penis had shrunk down to like 1" basically. The doc didn't really stretch it before injecting it, and now that it's stretching back out - it's like 3" flaccid but the drug appears to have gotten into "pockets" - it's not uniformly swollen. I'm not sure if that is a bad thing or what, but it just looks like a segmented arthropod or something.
I pray that I do not get an erection overnight. If that happens... I will end up in a hospital. I feel like the skin is gonna tear already in a few spots. When was your first erection after all this fun?
Your Frankenstein penis competition made me laugh...yeah - definitely. I realized there were no pics on the site and I was desperately looking for one earlier to I decided just to take my own...and see what people thought. I wonder if it'll be copied and end up in some xiaflex brochure or wikipedia - lol. I've always wanted to be famous for a deformed penis.
We don't have diclofenac here, as far as I know. I am in the USA. I wonder if we can take steroids (prednisone). Those knock out swelling very well - though not so great with bruising or immunity. Advil is not allowed in the trial due to bleeding. I doubt steroids are allowed - and they'd probably make a big deal about it even though they're pretty benign if used for <7 days.
I developed a very dark blood blister...I removed the pic because I just didn't want it out here forever.
thought about a cold pac?
BTW,
I was pretty similar post 3 hours, but didn't have as severe a reaction as you post 8 hrs. If I felt bad about it I would def call the dr after hrs if needed. They should be fine with that.
Get in touch with the doctors and insist one see you immediately. Don't take no for an answer.
Xtrialguy,
They look like swollen blood vessels.
The treatment made some of my blood vessels more prominent and hard too (which I'm slightly concerned about since treatment) but not like that.
Any improvement today?
When something frightening happens after a procedure, call the doc!
He or she should be available. One hour ago, I got a call from a parent about a fever in their child after a procedure my partner did (I am on call). I was able to answer their concerns and tell them under what conditions they needed to be seen. What good would it have done them to ask about fever after bronchoscopy on the internet??
I didn't mind the call. If I were a urologist and got a call describing what you show us, I would have told you to go to the ER to be seen immediately, and to have the urologist on call paged.
Tim
Wow - did things turn out ok?
Hi everyone
Update on results of cycle 2 and completion of cycle 3.
Measurement of curvature was 40º, which was an improvement of 2º. This was rather disappointing from the initial 8º improvement from cycle 1.
As I indicated in a earlier post, I found the injections to be increasingly painful and the first cycle 3 injection was the most painful yet. Up until this time I had not experienced any of the pain, swelling and bruising reported by other guys, I had only a little bruise around the inject site - well was I in for a shock.
About an hour after leaving I walked up some steps and and found this as very painful particularly within my scrotum (I thought this is strange and had to stop a couple of times). This pain lasted about 3-4 hours before settling down.
During the day I developed the swelling and bruising (black/red colour) which covered about 50% of the penis and about 20% of the scrotum. The Doctor advised that this was to be expected and it should settle down, but it is quite shock at the time. The next day when the bruising was fully developed, the site of the injection was somewhat tender to touch but not painful and I still had a sensation of something inside the penis, this sensation lasted a few days.
Cycle 3 - injection number 2 was something I was not looking forward to. After an inspection of the site the Doctor asked if I wanted to continue with this injection (not sure if this was just in jest). Having agreed to continue with this injection it was surprisingly the most painless yet, apart from the skin prick I didn't have any sensation of the actual injection whereas before I was experiencing a burning sensation when the drug was injected.
The bruising and swelling has taken about 5 - 7 days to disappear but have noticed that a slight bend to the left has developed which I didn't notice before. I have to report back when the bruising has completely gone and I will report this change as well.
The modelling session was completed with no problems and now wait until mid July for cycle 4. Maybe the bruising / swelling means that something major has occurred one way or the other.
Eveyone take care.
Thanks for the update!
Just to update, I saw the doctor - and he said it was normal. However, it is very disconcerting to see something like this on my own penis of all places. It's fairly unchanged since my first photo. I just removed the photos because the internet is a big place, and I don't want it floating around.
I called the doc that night, by the way - I didn't post all of that here. I just wanted to hear opinions of other trial participants because other first hand experiences are helpful since this is still very investigational. I don't know if anyone in the ER would have a clue about what is happening since it is a drug that nobody has really heard of, but he said I didn't need to go there anyway. Retrospectively, there's little they could have done in this situation because I am not in pain, and the blisters should not be lanced - at least, that is the most common belief about blisers. I am concerned about what will happen to the skin if it is not lanced, though...the longer it stays stretched out, the worse - right?
Has anyone else on here had a blood blister? If so, when did it go away? Did the skin look normal again?
Thanks for any advice. The consent form says the blisters should heal within 10-14 days, but it would be nice to hear it from a person if anyone experienced it.
Yes, thanks very much for the update saramon. It's odd too that some injections are painful and leave bad bruising, whereas others appear to be far less troublesome. I don't suppose it's uncommon for this to happen really, but I wonder why such differences come about.
Thanks for posting Xtrialguy. I'm too late to see the image, but the descriptions in the thread are probably sufficient. I suppose it could indicate a reaction to the drug, or perhaps this is not extremely unusual and will be perfectly fine soon. Please do let us know how it pans out for you. Good luck.
Newguy:
I can give you an explanation why some injections sites give more problems than others. My urologist told me that each and every injection site can and will give different symptoms, etc. The main reason she stated was that there was no way of knowing just where all the blood vessels are located - especially the smaller ones. They get punctured sometimes and other times of injection they do not.
So, bottom line, one injection might get a "clear" spot to inject and others may puncture the blood vessels and causes a hematoma condition. Hence, the bruising and discoloration for some shots and not for others. One thing that some doctors fail to tell the patient when giving injections is to hold pressure on the site so that blood flow will be minimized.
Hope this helps.
Old Man
I am going to have to disagree somewhat with Old Man's post and the information he was given by a physician. In the Xiaflex trial, the urologist performs an ultrasound of the penis and this should identify the plaque/injection area. If he is careful with his injection and uses the ultrasound as a map of where to inject, a blood vessel should not be injured.
Of course, this presupposes that the urologist will be careful and not in a rush.
ohjb1:
OK, but does each and every physician giving the shots use the ultrasound? I don't think so, as a lot of doctors do not have ready access to an ultrasound machine.
So, my information from my uro will apply in those cases where no such equipment is available.
Old Man
Quote from: Old Man on June 08, 2011, 03:53:49 PM
ohjb1:
OK, but does each and every physician giving the shots use the ultrasound? I don't think so, as a lot of doctors do not have ready access to an ultrasound machine.
So, my information from my uro will apply in those cases where no such equipment is available.
Old Man
Hi Old Man!!
If you are speaking of the Xiaflex trials, I'm thinking that here, in the states anyway, ultrasound is a requirement of the study, I would imagine that if a doctor can't have one done, he can't participate; but maybe you're talking about uros in general?
Also after my injections, pressure is applied to the injection site for quite some time to prevent bleeding and bruising.
BSSS
BTW, and while I'm here, I just completed cycle three injections. I was told that after two cycles I've had an improvement of 15 degrees. I also have multiple plaques, and some of the non targeted ones have become a little more noticable for some reason.
I was swollen pretty bad after injection 3/1 and not quite as bad after 3/2. Cycle 3 injections were less painful than Cycle 2, but I did have a 'jump off the table' feeling while the doctor was pushing the fluid from the syringe.
I have no complaints about the clinic where I report, the people there are excellent. But I will say that I don't think the science (injections) is very exact yet. All an ultrasound does is provide a road map for the doctor and my plaque was pretty hard to locate just from palpating. I feel that injecting experience of the doctor and a little guesswork on where to guide the needle play a larger part than they should, but I'm certainly not sure how the process could be improved.
I do plan to complete the study, but did have doubts after the second cycle injections were really painful, and I didn't think I'd seen that much improvement.
Will report after fourth cycle towards the end of July.
BSSS
My understanding of ultrasound and injection sites.
I only had the ultrasound on the initial consultation, I asked if further ultrasounds were needed and the doctor said no, only done to confirm the size/location of the plague.
Injections are located by (in my case) the mid point of the curve, this is remeasured before each cycle to provide a new location for the injection if the midpoint has moved.
So the aim in my opinion would appear to be to decrease the size of the curve (not necessarily to remove the greatest amount of plaque). The ultrasound would be of assistance if you wanted to target the largest/densest plaque formation each time.
Thanks
Hi Guys,
Just finished Cycle 3 injections. On day 1 of the cycle I didn't get an erection from 10 ml prostaglandin, so the urologist couldn't measure my curvature 1st attempt. He had to have another go the next day, this time using 20ml - worked well at that dose. Results - I started with 50 degree bend at baseline, now down to 20 degrees, so i'm happy with results so far. Had no adverse effects except purple bruising that took several days to dissipate. Main problem is finding a park near the clinic. The urologist says he can feel that the plaque has got softer. If I can get down to 10 degrees I'll be very happy. best luck to you all!
I'm finding it hard to believe that guys are having major changes with xiaflex. They post and go on scooters, all issue good with 20° change and are happy with it, I am not satisfied. I have yet to receive an injection.
Anyone participating as a farm animal and brave enough to speak anonymous, please do.Not that big of a deal as we know none of us are..Please share the experience as many of us can not.Yet we finmd ourselves willing to particapate
Fubar
Fubar
I am in the Xiaflex phase 3 double blind study and just received my third round of injections. If you have multiple plaques they will only treat the one that caused the greatest bend of the shaft. After the second round of injections I noticed a reduction in the size of the plaque. That second round was also more painful than the first and the bruising and swelling lasted almost 3 weeks. I was not able to do the modeling during that time as it hurt to stretch the shaft. The curvature has changed from 37% to 31%. It could be more but the other plaque which is close makes it hard to measure.
So far the bruising and swelling is less than the second round of injections but hurts just as much. I will post my results after the next measurement.
I am in the Xiaflex phase 3 double blind study and just received my third round of injections. If you have multiple plaques they will only treat the one that caused the greatest bend of the shaft. After the second round of injections I noticed a reduction in the size of the plaque. That second round was also more painful than the first and the bruising and swelling lasted almost 3 weeks. I was not able to do the modeling during that time as it hurt to stretch the shaft. The curvature has changed from 37% to 31%. It could be more but the other plaque which is close makes it hard to measure.
So far the bruising and swelling is less than the second round of injections but hurts just as much. I will post my results after the next measurement.
I am in the trial as well and just finished my third round of injections. I got swollen and black and blue each time. When Auxulium did the Dupuytren trials the common side effect was swelling with bruising. My doctor said that this has happened to about 50% of his patients in the current trial although two thirds of the patients in the phase 3 trial are supposed to be getting the medication and one third placebo. As such it seems some people don't experience bruising.
How serious swelling and bruising are we talking about!? Some guys seem to paint a pretty terrible picture! I'm asking because I'm concerned that it could actually create more scar tissue. Any improvements with girth? Cheers.
Just had my first two shots on the first round in the open-label study and everything went swimmingly. No change in curvature though. It's been a week. Will keep everyone posted.
I also just started the modeling procedure. Three times a day certainly doesn't sound like much. When I asked the urologist he said to just keep it to that but am tempted to do more modleing plus my FastSize extender along with it. Is anyone doing anything extra like VED or Pentos besides what they tell you to do? (Don't want to do my Pentox because don't want it showing up if they do blood work at the end of this.) Also, do you guys try to do the modeling in an erect or semi-erect state?
Thanks for the help! :)
N.
Just had my first two shots on the first round in the open-label study and everything went swimmingly. No change in curvature though. It's been a week. Will keep everyone posted.
I also just started the modeling procedure. Three times a day certainly doesn't sound like much. When I asked the urologist he said to just keep it to that but am tempted to do more modleing plus my FastSize extender along with it. Is anyone doing anything extra like VED or Pentos besides what they tell you to do? (Don't want to do my Pentox because don't want it showing up if they do blood work at the end of this.) Also, do you guys try to do the modeling in an erect or semi-erect state?
Thanks for the help! :)
N.
Hi nycsurfer
According to the instructions I was given stretching is done while flaccid and bending is done while erect
Regards
NYCSurfer,
I wouldn't take the pentox, first of all you want to effectively evaluate if your shots are working and evaluate if the xiaflex is working. Second of all pentox is a blood thinner, and could be a bad idea to take while getting shots, I would highly recommend avoiding this.
Good Luck,
Comebackid
Just curious, it seems like most people are getting some reduction in curvature, but is anyone getting a better erection?
Has it helped at all with hourglassing?
I ha e only gotten one round of shots but it hasn't helped with curvature or hourglassing yet. Stay tuned....
Quote from: nycsurfer on June 27, 2011, 02:18:26 PM
Just had my first two shots on the first round in the open-label study and everything went swimmingly. No change in curvature though. It's been a week. Will keep everyone posted.
I also just started the modeling procedure. Three times a day certainly doesn't sound like much. When I asked the urologist he said to just keep it to that but am tempted to do more modleing plus my FastSize extender along with it. Is anyone doing anything extra like VED or Pentos besides what they tell you to do? (Don't want to do my Pentox because don't want it showing up if they do blood work at the end of this.) Also, do you guys try to do the modeling in an erect or semi-erect state?
Thanks for the help! :)
N.
nycsurfer,
You asked if anyone is doing anything extra like a VED or Pentox. As far as we know, none of us in the study have done so because every one of us signed a contract stating that we wouldn't. In addition, to do so would probably change the study results whether you are getting Xiaflex or the placebo.
I'm in the followup part of the study now. It takes more than a week or two to get results. The nurse will give you the "official results" at your next visit and it will be in degrees. Since you didn't mention it, what is your starting curvature?
You didn't mention if you had swelling and/or severe discoloration (purple/eggplant color) so I assume you didn't have that.
Modeling is normally done in the flaccid state although it can also be done if you get a spontaneous erection. You should have received a card with modeling instructions.
I hope you will rethink doing anything extra.
Humorous
I can understand one putting there's own logic behind study and wanting to do more.However to be fare to the clinical study and its results.One should follow it by the letter, so to prove its worth in a resolve to this deformity.
Look as time goes on damage is done! We have all had broken bones, cuts, and infection.To see is what truly an effective remedy, could be following the guidelines to a study.Do not mess around!
Fubar
NYCSurfer,
One round of shots may not be sufficient enough to do anything. More importantly you want to finish out all the shots of xiaflex, then you can determine if you got the real drug or not, and if you did, if the drug worked or not. I would then take a month off to let your penis heal and then start pentox. I would highly recomend following the doc's protocol, you don't want to mess around with this, this isn't a gambling game, there will be plenty of time to take pentox or do the VED, peyronies doesn't move to fast, its a very slow progression, so slow you can't notice it, so its not an extreme emergency to start pentox. I had peryonies for more than 5 years before I started pentox and still saw reversal of damage.
comeBACKid
I just completed the four injection cycles and first follow-up appointment in the double-blind study. I live in northern California but because there are no test centers here, I commuted to southern California for the study. Before entering the trial, I had Peyronies Disease for three years. I'm now 64 years old. The only therapy I had tried was a cycle of verapamil injections which had no effect whatsoever. I was offered surgery by one urologist but didn't consider it. As a result of the AA4500 trial, my flaccid stretched length increased from 13.5 cm to 15 cm. My angle of (upward) deviation decreased from 44 degrees to 14 degrees, a very good result. The first cycle reduced the angle from 44 to 29, the second cycle had no measurable effect, the third cycle reduced from 29 to 19, and the fourth and final cycle, reduced from 19 to 14 degrees. There was the usual bruising and discoloration on three of the four injections cycles. I did all the modeling as instructed. Of course I am very pleased with the result and conclude I lucked out and got the real drug, not the placebo.
Wow that's awesome and thank you so much for sharing that with us! It gives hope to the guys on the trial who have had an injection and have seen no improvement. They should not assume that the following cycle will not help. In the UK there is no placebo and a few of the guys have noticed none to little change. The improvement in length is a bonus. Does this improvement in stretched length translate directly into improvement in erect length? Any help with girth or dents? Great news once again you must be so happy!!!
I am guessing that an increase in stretched length (measured in the flaccid state) must go hand in hand with decreased angle of deviation since both must be the good result of increased elasticity where the plaque is/was. No measurements were made in the erect state, and indeed it would be difficult to standardize such a measurement, but I would have to say that, subjectively, the length has increased. I didn't have any problem with girth or dents (no "hourglass") so can't comment on that. I do remain puzzled why there was the second cycle of injections had no effect while the others did, but perhaps it was a function of exactly where the injections were made. Anyways, good luck ahead - I hope it works out for you in the subsequent injections.
I have completed Follow-Up Visit 2, which is at week 33. This was the "simplest/easiest" visit since no blood was drawn and no injections were given. All the Dr does during this visit is check the hardness of the primary plaque. He indicated there was no change.
The next visit is in nine weeks. There will be an injection and curvature measurement.
Humorous
I was in the peyronie study and did not have a positive experience. One thing I noticed in the Auxillium literature is that they state there has not been any long term adverse events from treatment -and then they qualify it by adding to the statment - not due to the drug.
This is not clear and I don't know exactly what they really mean.
Quote from: ohjb1 on July 16, 2011, 12:55:50 PM
I was in the peyronie study and did not have a positive experience. One thing I noticed in the Auxillium literature is that they state there has not been any long term adverse events from treatment -and then they qualify it by adding to the statment - not due to the drug.
This is not clear and I don't know exactly what they really mean.
The Xiaflex prescribing information (on the market) also has vague comments about the creation of antibodies to collagenase and possibly other MMPs...and the long term effect of these antibodies is unknown.
"Since the protein components in Xiaflex (AUX-1 and AUX-II) have some sequence homology with human matrix metalloproteinases (MMPs), anti-product antibodies could theoretically interfere with human MMPs"
I assume this isn't a big deal since it was approved? But what will happen to people with antibodies to
their own collagenase. Wouldn't they be worse off long term? Nobody really knows what ALL the MMPs do - and they are very complicated... so... it's really a vague / grey area.
Have just completed cycle 4, surprisingly the injections for this cycle were virtually painless which was a pleasant surprise.
Again some bruising and swelling but only about half as severe as last time.
As reported earlier, my cycle 3 injections resulted in a large amount of bruising and swelling which took about 10 days to subside.
The measurements after cycle 3 were 10° improvement in curve but no increase in length.
So starting from a 50° bend:
Cycle 1: 8° change, no change in length
Cycle 2: 2° change, no change in length
Cycle 3: 10° change, no change in length
So curvature down from 50° to 30° but no change in length although I think I have developed a slight twist to the left but this just may be more apparent with the reduced curve.
Cycle 4 measurements due in about 6 weeks.
My personal perspective on the process thus far is:
Initially I found the injections painfull when the drug was being introduced into the plaque (a stinging sensation) which was getting worse each time until the bruising and swelling occurred after the 1st injection of cycle 3. Since that time the last 3 injections have been virtually painless.
The bruising and swelling would appear to be a tipping point in the procedure where major change occurs (in my case) so with this 2nd round of bruising I am optimistic that I may get another largish change from this cycle.
I have developed a sensation within my penis when it is erect, like something is in there and is a little tender from certain angles, the doctor did not seems to be to concerned about this when I reported it.
Not sure how effective the modelling is but I have found it to become a bit painful, particularly the bending against the curve so it might be doing something or is a result of the internal sensation (see above).
As I appear to be getting the real thing I can only recommend this treatmeant as a very viable alternative to surgery, this is only very early days for this drug and the results for me have been excellent and hoping to get further treatment if it is viable at the end of this trial to see if I can improve further.
Might be worth buying shares in this company although burned by biotech investments in the past.
Will provide another update after the next measurement session.
Thanks
A corporeal rupture has been reported from the xiaflex trial. Additionally, serious cases of blistering have also been reported that have taken months to heal (unlike the 2 weeks in the original consent). This was told to me as I was asked to sign a new consent form in the study - even though I had all my shots, they are telling us this now...I suppose it is necessary to tell us since we are staying in the study to get the real drug eventually.
The man with the tunical / corporeal rupture had to undergo surgery (lucky him) - I didn't get the details about who did the surgery - but I am sure Auxilium paid (per the consent). The scary thing is that I would only want a very select few docs to do the surgery - and I'm not sure my study doctor knows about the extensive complicated surgery that people like Levine, Mulhall, and Lue, can do with grafts. I doubt AUX gave this patient a huge choice of surgeons. The sad thing is this patient now probably has a worse deformity and significant healing process, than he did before the trial. The other thing is that I really think this should NOT have happened. Collagenase, when injected properly, shouldn't cause this. I suspect this was due to poor injection technique, but this was not something I was told. I do know someone in the Xiaflex trial whose doctor is terrible and just injects under the skin - not into the plaques. He's had no results except very very bad side effects. There's really no way to tell AUX what is going on at this study doctor's site because their view on patients is basically "what do they know"? So, some doctors are not following the protocol and not injecting plaques directly or following other procedures. I'd love to name names but I can't. PM me if your doctor is like this. I am curious if the same offender is doing this to multiple people.
Mike
This sucks, but someone is going to throw the dart.However giving injections one can make a mistake.My docs send me to the lab and have blood drawn all the time.Some blow a vein amd i have huge bruises to show for weeks.So you are rolling dice with Any injection .There are going to be causality no matter the procedure.
Fubar
when they give you the injections for xiaflex do they give you the injection in a erect state or a flaccid state?
Quote from: agent0 on July 29, 2011, 06:42:22 AM
when they give you the injections for xiaflex do they give you the injection in a erect state or a flaccid state?
flaccid
Just had my cycle #2 shots of xiaflex over the weekend... one each day.
The shots were MUCH more painful than cycle #1 and the bruising swelling is MUCH worse (me penis today looks like an eggplant, jeesh...).
Will let everyone know once the swelling goes down whether things have improved. They did not improve much at all (if any) after the first cycle of shots.
More to come...
Is Xiaflex being used on those who are stable only? any one in the acute stage involved in the test?
In the UK study you have to have had peyronies for 1 year or more.
Hey nycsurfer
I think the eggplant look is maybe a good thing, you might be pleasantly surprised with the next result.
regards
s
I would like to say that there is hope and there are miracles. I would like to state that my experience and condition is my own and as we know each man has a condition unique to them. Also any statements are of my experience and opinion and may not apply to others. Many have been waiting for reports on the phase III trial using Xiaflex. I have waited until I finished my trial to share my results. I was diagnosed with Peyronies at the beginning of 2006. Due to the condition I was offered surgery as a way of treating my condition. I might have gone that route, but my financial situation would not make that possible. I did try some of the oral supplements and the ved, but did not receive any improvement. I became aware of the Phase IIb trial starting up and my doctor was one on the list for the trial. I was accepted for the IIb trial and finished it. I was one that received the placebo, but was told from the beginning that if I did I would be offered the open label ( real drug ) when the Phase III trial started. I started the Phase III open label trial in Oct. 2010 and have finished the trial as of Aug. 2011.
When I started the Phase III open label trial my bend was at 78 deg. to the left. This made sex impossible for me. At the end of my trial I was at 10 deg. I gained back 4 cm in length and I feel my girth is back to my normal.
I have know idea when the drug will be approved or any idea of the cost. If anyone would like to send me a PM I will try to answer the best I can. I will make a post to the improvement section of the forum and give a few more details.
I would like to thank my doctor, his trial assistant and Auxilium for my miracle. Musicman
Congratulation Musicman, your final results are outstanding.
Your experience really demonstrates the effectiveness of this drug and should provide a viable non surgical alternative for other sufferers.
Regards
S
MUSICMAN,
This is exactly what what this forum has needed; significant improvement of a really severe curvature. Going from 78d to 10d is OUTSTANDING, not to mention gaining back some length and girth.
Please stay with us here on the forum and keep us updated. You have given us hope for a brighter future when all we typically hear is more bad news.
GS
I agree GS - this is Music to my ears Musicman and good for you for sticking the whole process out ... lot's of sad stories and negativity on the blog sometimes and great news to read about a drug that is working - and a man that has persevered ... now get out and enjoy that new toy!!
Woo hoo! Thanks for sharing!
Congrats musicman! Good news for sure!
Great news Musicman! Your post is a ray of hope to all of us out here suffering from this largely hidden condition.
I too considered surgery, but decided against it. This news makes me think I might have made the right decision.
Please make sure you keep us informed of how things go from here.
little bit of an update:
over the past few weeks I've had my cycle 4 injections and my first follow up visit.
My cycle 4 injections did not go well. I had a delayed reaction to the first cycle 4 injection and the reaction was bad enough that I wasn't able to receive the second one. I wasn't really happy with that, but I had little choice in it.
A couple weeks ago I had my first follow up and learned that I've had a total up to this point 15 degree improvement in curvature and a small gain in length. I also did notice a little hourglassing I hadn't seen before which I feel was due to the extreme reaction I suffered from the cycle 4 injection. I do feel that this might resolve though because I've seen healing from that experience. I thought I had suffered a ruptured vein then and to be honest still feel that's a possibility.
As to my curvature reduction, I absolutely see the improvement when erect. I'm really not far from where I was before Peyronie's curve-wise. I did have some congenital curve...prob 25-30 degrees pre-peyronies, and am back to that level after the 15 degree help.
I honestly do not know what I received. From my reaction to it, I suspect I received the drug, but also saw that some placebo patients received 15 degree improvements just from the swiss cheese effect. Not sure when I'll find out, but the nurse seemed to think that an open label study might still be available for placebo receivers in this phase. We'll see....
I've talk about xiaflex with a girl from a pharmacy. She was nice enough to call Pfizer and ask them when the drug will be available in France. According to the lab, in march 2012 the Xiapex (french name of xiaflex) will be available for Dupuytren. But nothing about peyronie's disease.
I plan to have an appointement with my uro and talk about him about off label use of it.
Ben
I wonder if your urologist will have access to xiaflex sense it is not approved for Peyronie's. Worth a try though. It would be great if he would help you, good luck.
Fubar
Fubar
If I discuss with him about evidences that xiaflex can by worth to try I'm quite sure it will be ok for him.
I don't know the legal status in other countries, but in France a med. doctor can prescribe almost anything.
The only restriction I know is "primo prescription", which means that the prescription needs the be initiate by a hospital practionner, then can be followed by a generalist. Ritalin and metadone are example of it.
A demand for temporary autorisation of use (ATU) can be done too. It can allow a doctor to administrate to his patient a drug that has been withdrawed of the market, but in this particular case will be less bad than doing nothing.
Yes maybe 2012 will be the end of the world and the start of a new one who knows ?
well, have a nice day !
Auxilium have taken specific steps to try to prevent the use of Xiaflex off-label for Peyronie's. Dont recall the exact details but it includes making it only available to certain groups of specialists that treat Dupuytrens and only after undergoing certified training. They appear to be taking precautions as part of the Peyronies trials to ensure no bad experiences come to the surface before full licensing.
Have now completed all cycles and 6 week followup.
So starting from a 50° bend:
Cycle 1: 8° change, no change in length
Cycle 2: 2° change, no change in length
Cycle 3: 10° change, no change in length
Cycle 4: 0° change, no change in length
So curvature down from 50° to 30° but no change in length. I have developed a noticeable twist to the left as I now think the plague was pulling to the right (and keeping the penis somewhat straight).
Although I experienced a major improvement I am a bit disappointed that I didn't gain a greater improvement.
The Doctor said that he could not feel any plaque so he was successful in targeting that. The remaining curve and twist must be caused by something other than a large detectable mass of plaque. He does not use any ultrasound in the examination.
Next followup at 52 weeks I think.
Overall, erection strength is greatly improved, curvature reduced but the twist has developed. I would rate my result as a 60 / 40 success (personally) as the twist is a disappointing development and I am still missing about 2 - 3 Cm's of length.
I would recommend this treatment because as reported in other threads this is a fantastic non surgical alternative which can produce stunning results.
Thanks
S
saramoon:
Good news about your results of the Xiaflex trials. Now might be a good time to add in the VED therapy since you seem to have been relieved of the plaque.
The stretching of the VED therapy should give you good results as the erectile tissue would be in a flexible state. However, I would wait a few weeks before starting the therapy. And, also I would suggest checking in with your uro to make sure he would agree with it.
Old Man
Old Man
Thanks for that, I will definitely look into the VED therapy. Your suggestion as a followup would seem to be a sensible continuation.
I was wondering what the next steps would be as the doctor did not seem to have any other options or opinions at this time.
I find a reluctance for any imaginative alternatives to be offered by the medical profession a bit disappointing at times.
S
There is something I don't understand with the xiaflex trial. It was said that the men with calcified plaque were excluded, and for me if someone could feel an hard plaque in the penis it has to be calcified isn't it ?
Xiaflex is designed to break collagen, and plaque are made of collagen, so i don't understand the inclusion critera of this study.
The collagen buildup is also referred to as plaque and this can be felt. It is during this time period that Xiaflex is more apt to work and break down the collagen.
After 12 months or so the plaque can calcify. There are several theories on whether anything other than surgical removal can be done on calcified tissue. Men with calcification were excluded from the trials as Xiaflex is less likely to help in this situation. And of course the people running the trial would like to prove its efficacy and therefore want the "best" candidates.
I completed Follow-Up Visit 3 earlier is month, which was at week 42. There was an injection and curvature measurement which was 30 degrees. Since this was 5 degrees less than the last measurement (May 2011), I have to revise my totals. The total now is a 30 degree reduction (started at 60 - ended at 30 = 30). So, averaging that over four cycles, that's 7-8 degrees per cycle (although in reality, there was one cycle where there was no change).
The next visit is in ten weeks (week 52) and is the last one in the study. They will draw a blood sample, there will be an injection and measurement, and I will complete three questionnaires. After that visit I will be discharged from the study.
Humorous
Well that is very positive! How do you feel about that? Are you at a point where you can live with it?
Worriedguy
The man is living with it, and giving revue.I think that says it all.
Fubar
great news humorous! Glad to hear you've had more improvement!
Quote from: Worried Guy on September 24, 2011, 06:28:43 PM
Well that is very positive! How do you feel about that? Are you at a point where you can live with it?
Worried Guy,
It is positive - 30 degrees certainly is much better than 60 and I am living with it. However, it would be nice to get at least 15 degrees more. They haven't announced the criteria for the next study yet. (The one that everybody in this study who received the placebo will be able to participate in which I believe will start around next spring.) If I meet the criteria I'll try to enroll.
I strongly encourage any of you to enroll in that upcoming study (if you qualify) even if you have to go far from your home. (There are a couple of people that drive several hours (one way) to participate in this study.) Xiaflex really works IMO.
Humorous
H3
I hope you are able to participate in the next study that would be great.The chance of further improvement. I wonder I'd they will include my area this time. I don't think I will be able to travel anytime soon.
Still worth looking into!
Fubar
I want to comment on Ben's comment on the calcification, we heard this before, that if your penis is "hard" then its calcified and can't be reversed. However, after about 7 years I went on pentox and my hard penis totally went soft again after 7 months of pentox. Since getting off pentox my penis slowly hardened again and got worse over the course of 2 years, now I'm on pentox again, I will keep all updated with my progress. I don't believe that calcification can't be reversed, cause I believe mine was, so I'm not sure if I agree with the premise of the xiaflex study.
Comebackid
Quote from: ComeBacKid on September 30, 2011, 03:11:55 AM
I want to comment on Ben's comment on the calcification, we heard this before, that if your penis is "hard" then its calcified and can't be reversed. However, after about 7 years I went on pentox and my hard penis totally went soft again after 7 months of pentox. Since getting off pentox my penis slowly hardened again and got worse over the course of 2 years, now I'm on pentox again, I will keep all updated with my progress. I don't believe that calcification can't be reversed, cause I believe mine was, so I'm not sure if I agree with the premise of the xiaflex study.
Comebackid
Scar tissue in the penis is hard. My plaques are very hard but do not show calcium on the ultrasound. Some are nearly as hard as bone, though there is no calcium in there...yet. How much pentox were you on for 7 months? I wish I could stay on that stuff but I get side effects. Did you get any?
Mike,
I can't imagine I just had scar tissue, I had the hard stuff in my penis for 7 years before I started pentox! Yes I get side effects which are: Dry Mouth, headaches, increased sweating, delayed ejaculation time, difficulty breathing when walking up hills or steps, blurred vision etc... Did you get any of those? None of them are so overwhelming I want to quit the drug.
When I was on pentox before I was on it 2 pills per day, and then 3 pills per day for about 90 days, then back to 2 pills per day, I saw significant improvement, like 80% improvement.
Comebackid
Quote from: ComeBacKid on September 30, 2011, 07:05:56 PM
Mike,
I can't imagine I just had scar tissue, I had the hard stuff in my penis for 7 years before I started pentox! Yes I get side effects which are: Dry Mouth, headaches, increased sweating, delayed ejaculation time, difficulty breathing when walking up hills or steps, blurred vision etc... Did you get any of those? None of them are so overwhelming I want to quit the drug.
When I was on pentox before I was on it 2 pills per day, and then 3 pills per day for about 90 days, then back to 2 pills per day, I saw significant improvement, like 80% improvement.
Comebackid
That's great... I had sleep issues (which turned into mood issues) and some headaches. So, it was hard to stay on it. I didn't get any results from a few months of it. If i knew it would work 100% i'd just deal w the side effects, but there wasn't much change. I didn't take it that long, though.
Lets say pentox and xiaflex can break down collagen. What repairs the the dead tissue ( scarred) elastic fibers of the tunica ?It has to come from a cellular level.A healthy stem cell culture from that body part or what Dr. Alata is working on a printable organ.
I know its crazy but if you look on the net he started out wanting to conquer Peyronie's? Know he has grown bladders that are in humans and created urethra s for some.
He is probably the foremost urologist that would have interest in our disease and finding a cure.Blowing a balloon up every day wont rid the wall of the gum stuck to it.
Fubar
Fubar,
Did you send that letter to him, keep us updated.
Mike,
I have sleep issues to, it takes some time to get used to the side effects, thats why you dont start out on three pills per day in my opinion. The thing is with the sleep issues, I can't say its all from pentox, sinc eI've been staying up until 4-5am before I was taking it.
Comebackid
There are plenty of other pages to discuss pentox on.
Worriedguy
You have made the only post today on the forum.Congratulations on your positive post!Yes it would be nice if everything was perfect I was there too at one time.The last year or so people have been posting everywhere. However I did try to get it back on topic mentioning xiaflex and collagen. Boath words relating to this very thread.
Fubar
Fubar,
Worriedguy actually brings up a good point, it seems that our forum has grown a bit like a spider web, or the tax code... okay maybe not that bad :D I think the forum would benefit from some more volunteer moderators since hawk, myself, and the others can't do it all. How does the forum feel about this? Does anyone else feel like we have to many topics? I've gotten a few emails from people saying they belive there is to many topics.
Comebackid
All,
I log in pretty much every morning and read all the new posts. If I know anything about any of the posts, I respond with my opinion. If I don't, I garner whatever information I can from the posts and log in again the next morning. If there is a particular drug or therapy mentioned, I go to whatever website I can find and research the item.
I've been doing this for close to 3 years; I've become comfortable with my VED; I've switched from COQ10 to Ubiquinol; I'm taking Vitamin D, low dose Viagra and L-arginine everyday along with my regular vitamins and prescriptions, including Pentox.
Other than getting the Xiaflex injections, I don't know what else I can do or can be done or said. I think our Forum has been extremely valuable to me and to all the others; how else would we all know about all the new information. But, we are talking about a disease with no known cure and there is very little that can actually be done.
I also think there is a lot of good done by talking about it and knowing we are not alone in our struggles. As they say, "misery loves company".
These are just my initial thoughts on the efficacy of our forum and I will continue on as long as the forum is here. I look forward to hearing others' thoughts and ideas.
GS
Quote from: GS on October 05, 2011, 09:35:03 AM
All,
I log in pretty much every morning and read all the new posts. If I know anything about any of the posts, I respond with my opinion. If I don't, I garner whatever information I can from the posts and log in again the next morning. If there is a particular drug or therapy mentioned, I go to whatever website I can find and research the item.
I've been doing this for close to 3 years; I've become comfortable with my VED; I've switched from COQ10 to Ubiquinol; I'm taking Vitamin D, low dose Viagra and L-arginine everyday along with my regular vitamins and prescriptions, including Pentox.
Other than getting the Xiaflex injections, I don't know what else I can do or can be done or said. I think our Forum has been extremely valuable to me and to all the others; how else would we all know about all the new information. But, we are talking about a disease with no known cure and there is very little that can actually be done.
I also think there is a lot of good done by talking about it and knowing we are not alone in our struggles. As they say, "misery loves company".
These are just my initial thoughts on the efficacy of our forum and I will continue on as long as the forum is here. I look forward to hearing others' thoughts and ideas.
GS
That sums up how I feel about using the forum very nicely. Additionally, I really like how the icons light up next to the different forum sections when a new post is posted within any the threads. Maybe some of the threads could be combined.
Such as, combining Progression of peyronies, congenital curvature or Peyronies Disease and causes of Peyronies Disease. Also, On the light side and open questions or general comments could go together. Maybe the off topic section could be in the open discussion as well. Doing these changes wouldn't help me or someone that's been around for awhile but it might with newbies and not feeling overwelmed.
I agree with the latest statements made here in this thread.Most importantly I agree with worriedguy. .Come back yes we need more moderators , not my job.
I would however nominate worriedguy? He is honest and true in nature.I like those attributes in a person.
Please consider him as a moderator. I think he would be a wise choice.Or maybe newguy personally I think the best choice as moderator.Have much respect for newguy, knows how to handle the challenge.
Just my two cents if you are looking for leaders in tactic moderation then newguy is your man.Will he except the challenge do not know. He definately stands out from the crowd.
Fubar
Fubar, thanks for the compliment. I did not mean to be rude before and have been guilty of posting off topic myself. I believe this trial is important and I like to know as much about it as I can. That was my gripe.
I would be interested in helping out, but have never really done anything like this. This forum helped me so much in the early stages when I felt very down and people like yourself, Newguy, George, GS, Oldman and so many others helped me realise that my life was not over and there is light at the end of the tunnel. I want to help others now. I've still not had this blasted disease for a year yet.
I'm also short on time at the moment with staying away for work. wifi can be very expensive in hotels so I don't have access during the week. This staying away is playing havoc with my VED routine. I'm having to share a room some weeks to keep cost down during these hard times and I don't feel comfortable taking the VED with me. I'm not sure how much time I will have and this is one of the reasons why I've not been on here much.
I will have a chat with comebackid to see what it entails
Worriedguy
Dont sweat the small stuff.Yes this whole ordeal can be tough finding time to use the ved and time just to put things in perspective. I'm having a bit of turmoil this week with it all.You are absolutely right about topic and where it should be.But it did take time to relize we can not change outcome.And brothers need to make that connection and they do not think all the time.I like to pm mostly that way I'm not desturbimg the forum.But like you said we all make that mistake.Dealing with this dish we did not order.
I'm in it a year and a half I have ups I have Downs.I have times when everything I have learned I question over and over again.I am sure the guys long standing have felt the same.speacialy when half of their post answer the same questions over and over.
This Peyronie's is definatley a hard road , newguy once told me it is our particular challenge. I can't tell you exactly how I felt about his statement but it is much better than challenging a missle to the face.
Fubar
when is this drug coming out! im tired of waiting. this drug seems to be the only thing thats keeping me move foward. im tired of my penis being numb, and im tired of this hard lump being in my penis. please if anybody hears when the drug is coming out please post it here.
I listened to the last conference call. They said final data from phase 3 trial will be out the beginning of the second quarter of 2012. My guess is that the drug would be out after that if there are no insoluble problems.
JW1441
Thanks for giving us this info. From what you know , when it is finally introduced, would it be Global ( US / Canada / U.K . Pacific Rim , Europe etc etc for example) or would each country require their own Food & Drug authorities to approve it for distribution before we can all take advantage of it? That could take awhile.
Mike67
The FDA still has to review it...which could take a long time. I have looked up the Dupuytren's trials to get an idea, below. Also, I saw a youtube video of a trial participant who reported her last injection was in August of 2008 (in a phase 3 trial). more on her below.
Here's some of the study info:
Joint I (Phase 3)
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Cord II (Phase 3 - non US)
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
The "primary completion date" (when patients have their last visits) is estimated to be March of 2012 for the Peyronies Disease studies, and for some reason the study completion date is supposed to also be in March, though it looks like it usually gets delayed based on the above. It appears that patients were done with their trials in the fall of 2008 (which coincides with the woman in the youtube video who finished in August 2008) and the FDA approved in in Feb of 2010. This is very fast (17 months)...and we can hope that it may be even faster given that the drug is already on the market. Then again, with this being in unknown territory (not many approved penis injections out there) - who knows.
So, my guess is that it will be on the market 12-18 months after March of 2012, which would be March of 2013 - September 2013.
Then, let's see the fun begin with insurance companies covering each 4k injection + doctor's fees... easily $30-40,000 per patient.
As for the woman who recorded her trial experience... the cord came back a year later. I don't know if this means anything that serious - it could have been another cord, or it might have returned after the NA procedure... but its not a good sign. I don't think it will affect approval, but in 2020, we'll know if it actually works in the long term:
http://www.youtube.com/watch?v=_hJHVsl9nzw
just had my second follow up visit; no injections, only an exam by the doctor. Not much to report, seems there's no change since the last report, but there were no measurements taken either.
Hello all,
I haven't posted in a while, but I've had Peyronie's Disease for almost 4 years now. I'm pretty much just waiting for the final results and an FDA approval of Xiaflex before I go back to any doctor in the hopes for a successful treatment. I don't know if you guys have seen, but they're advertising Xiaflex like it's Viagra now for Dupuytren's Contracture. Anyway, I was just wondering for the guys that have been through the trials, and who have had success or at least partial success, if they could give up some names of Doctors that treated them (preferably in the NY/NJ area). I'd like to go see a doctor that has had success in doing this procedure, as I suspect that the drug itself as well as the doctor injecting it are equally important. I myself had a doctor inject my penis with something that caused the majority of my problem now, so I'm very cautious. My plaques seem very hard so I'm really not even sure if I'd be eligible, but speaking with a doctor who has experience, might help me figure things out. So thanks in advance for anyone that can give me a reference. In the mean time though, I get to disappoint the girl I'm seeing this week as I'm probably going to have to explain all this crap to her. I wonder if she'll stick around?
bummed
I know a lot of women who prefer oral sex to penetration. I was aware of it before Peyronie. There is a lot to do to please a woman, touching, kissing... Give her pleasure, don't depreciate what you can do. Sex is 80 % emotionnal 20 % physical.
As for xiaflex and good uro, can't help.
Try Dr. Gilbert in Great Neck Long Island on Northern Blvd.
Hey all. I've been travelling for about 3 weeks and have been off the boards during this time. So trying to catch up on all the activity.
I had my annual check with Dr. Levine yesterday. We had conversation about the Xiaflex trials (among other things). Just wanted to share that he did mention that for the men who did respond to Xiaflex that thy have seen good improvement. But it seems that the percentage of men who do respond is smaller than expected. He also said it would take time to compile the data and that it would be the end of next year before anything conclusive.
I know many would like something more positive and sooner than this, but just wanted to share this with the group.
Quote from: lwillisjr on November 17, 2011, 09:54:22 PM. We had conversation about the Xiaflex trials (among other things). Just wanted to share that he did mention that for the men who did respond to Xiaflex that thy have seen good improvement. But it seems that the percentage of men who do respond is smaller than expected.
I think this is because of the highly restrictive study design. Instead of injecting all plaque or all the way along a distributed plaque, they would only put it in one spot. So, this won't dissolve the plaque. When doctors are free to do things how they want - and target multiple plaques or entire plaques, results will probably be better. I just hope this doesnt force the company to do an entirely new study...which will delay this 2 yrs.
I have participated in the open-label Xiaflex Phase 3 trial. I´m not convinced that this is the solution to Peyronies disease. At the screening I had a deviation of 70° to the left. Last week I had my FU2 meeting -examination. The doctor found the deviation approx 60°. The accuracy of the measurement could be questioned.
I have come to the conclusion that the drug must be modified. The "half-life" of the drug must be extended to at least 7-10 days and the capability to diffuse in the plaque-tissue must be much better.
Thiswontwork.
Are you in the US or UK trials?
How do you know you are not in the placebo group?
Is this after all cycles of the trials?
Quote from: UK on December 02, 2011, 12:43:37 PM
Thiswontwork.
Are you in the US or UK trials?
How do you know you are not in the placebo group?
Is this after all cycles of the trials?
Read my post - I participated in the OPEN_LABEL trial - that means I got the real stuff. This is after all 4 cycles. I´m not in US or UK - I´m in another EU-country - that´s enough.
Sorry if I get you all disappointed but why should I hide the truth. Remember that this drug is not new. In the early 80-ties "Gelbard" performed some trials and after that nothing happend until now. Why? I think you all know what this about ..... $$$$$$$$$
Quote from: thiswontwork on December 02, 2011, 01:43:09 PM
Quote from: UK on December 02, 2011, 12:43:37 PM
Thiswontwork.
Are you in the US or UK trials?
How do you know you are not in the placebo group?
Is this after all cycles of the trials?
Read my post - I participated in the OPEN_LABEL trial - that means I got the real stuff. This is after all 4 cycles. I´m not in US or UK - I´m in another EU-country - that´s enough.
Sorry if I get you all disappointed but why should I hide the truth. Remember that this drug is not new. In the early 80-ties "Gelbard" performed some trials and after that nothing happend until now. Why? I think you all know what this about ..... $$$$$$$$$
These are the reasons why I've heard it hasn't worked that well so far:
1. Need to use it with traction in the weeks between injection to force the scar to break apart more (similar to the snapping done in the dupuytren's patients...too dangerous to "snap" the penis in Peyronies Disease since the scar is not separate from the tendon)
2. Plaques can be extensive and in multiple locations, but the study will only allow 1 injection in 1 location of 1 specific dose. (was this the case with you?)
3. The body might just make more scar tissue over time (we need better drugs to suppress this)...long after the study is over
4. Injection might not be deep enough bc doctor is worried to cause a penile fracture. This would injure the skin quite a bit..which has happened to some people... does nothing to the plaque. What happened during your injections? Any skin damage / blistering?
Also, I found it interesting to hear that elastin is irrelevant...that just causes a counter-force on the erection. You just need to dissolve the collagen to cure peyronie's. Collagen lets the skin stretch, elastin brings it back - but you don't "need" elastin in the same way.
It's very expensive for a pharmaceutical company to take a drug to market for a non-life-threatening disease...that's partly why it took 30 years since Gelbard first started. There is no money in it - with only a small % of men having Peyronies Disease. It probably only became profitable after the invention of viagra - since many more men in older ages are noticing Peyronies Disease with their cured ED.
Not disappointed. In fact I don't believe a word you say. You are new poster turned up out of the blue so you have your own agenda. But that's just my opinion.
In fact I have heard really positive stuff about this round of trials, not just on this forum. There have been some immense improvements and some not so good. Don't worry Auxilium will know exactly why - they will even know if it was a particular doctor being better than another, from their averages being better than others across their pool of patients and learn and adapt techniques from that. A ton of data is gathered from each participant.
Read my post - I participated in the OPEN_LABEL trial - that means I got the real stuff. This is after all 4 cycles. I´m not in US or UK - I´m in another EU-country - that´s enough.
Sorry if I get you all disappointed but why should I hide the truth. Remember that this drug is not new. In the early 80-ties "Gelbard" performed some trials and after that nothing happend until now. Why? I think you all know what this about ..... $$$$$$$$$
[/quote]
No need to be patronising - The majority of posters here are considered and not stupid enough to blindly think that a drug in testing is going to solve all their problems. Drugs companies make drugs and sell them ... big deal ... if it's proven to be effective I'll buy it
Disappointed? Disappointed that the drug did nothing for you ... probably not as disappointed as you - glad that several other posters here have seen positive results and happy for them. Looking forward to seeing the full trial results which should be available sometime in the next 6 months
I completed my final followup visit last month, which was at week 52. There was an injection and curvature measurement which was 28 degrees. This was only 2 degrees less than the last measurement (May 2011), so I won't revise my totals. The goniometer, (a ruler that measures angles, which allows the study doctor to measure the degree of curvature in your penis), is far more subjective than objective IMO. Therefore, I will discount the 28 degrees and stick with the earlier readings of 30 degrees.
To recap, the total was a 30 degree reduction (started at 60 - ended at 30 = 30). So, averaging over four cycles, that's 7-8 degrees per cycle (although in reality, there was one cycle where there was no change).
I am pleased with the reduction, of course, but would have liked to end below 15 degrees. (Who wouldn't, right?)
Humorous
Thiswontwork,
In your first post you stated "Last week I had my FU2 meeting -examination." (I'm assuming "FU2" means 'followup #2'.) Your second post said "This is after all 4 cycles." Please clarify for those of us in the USA. Thanks.
Humorous
Quote from: Humorous3 on December 05, 2011, 12:02:49 PM
Thiswontwork,
In your first post you stated "Last week I had my FU2 meeting -examination." (I'm assuming "FU2" means 'followup #2'.) Your second post said "This is after all 4 cycles." Please clarify for those of us in the USA. Thanks.
Humorous
Quote2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)
add 3W. in front of > clinicaltrials.gov/ct2/show/NCT01243411?term=Peyronie%E2%80%99s&rank=1
look under Assigned Interventions
I hope I made it clear the meaning of "cycles".
Do you have any information of any other current trails taking place within the UK?
Quote from: Humorous3 on December 05, 2011, 11:49:40 AM
To recap, the total was a 30 degree reduction (started at 60 - ended at 30 = 30). So, averaging over four cycles, that's 7-8 degrees per cycle (although in reality, there was one cycle where there was no change).
Did you have any size increase in length or girth? Was this an issue when Peyronies Disease progressed for you? Or was size never a problem? Peyronies Disease has caused worse size issues than curve issues for me...so any insight would be great. Thank you.
This is a test to see if my posts go through. I have had some computer problems. It seems that some are a little disapointed in the "Xiaflex" results. Have you read my story under the "Improvement" board under the heading "Suscess"??? Musicman
Hi Everyone
Have just completed my penultimate followup prior to Christmas which involved a measurement, I'll never get used to those injections.
Just to recap from my previous post back in September where I reported the following changes over the course of the trial:
Cycle 1: 8° change, no change in length
Cycle 2: 2° change, no change in length
Cycle 3: 10° change, no change in length
Cycle 4: 0° change, no change in length
This time the Doc measured a further 2° improvement and mentioned that he was seeing ongoing improvement in a number of other patients in the followup period.
The measurement process is not a precise science but hopefully he has enough practice to be consistent.
He also reiterated that he could no longer detect any plaque which he seemed to think was significant.
So overall improvement now at 22° leaving me with a 28° curvature.
One more follow up in 6 weeks so will report the conclusion of my experience after that.
Thanks
S.
Hope someone can help and advise.
I contacted David Ralph's clinic in Harley Street at the end of September. I was absolutely over the moon when I received a telephone call from one of the nurses almost straight away saying that it was my lucky day as there were a few spaces that had become available on a trial which was to begin the first or second week of October. She said she would get back to be with a date and time for a screening appointment.
I heard nothing so emailed her. She called me to say the trial dates had been delayed a bit but would contact me with an appointment very soon.
A month went by and I contacted her by email for an update.
I received an email asking me to answer five screening questions which I replied to with answers.
I heard nothing and emailed again to check that they had received my answers. They said they had. This was early November.
Since then I have heard absolutely nothing. I am frustrated because time is ticking by and am scared of calcification. Also having a demo of a VED pump at my hospital, I was advised to await using it until I had this trial as they thought Dr Ralph would not like me having alternative treatment.
Does anyone here know what is going on? Any advice how I should proceed?
Hey there. My piece of not-so-good news is I just got through with the Xiaflex trial last month and I came out looking even WORSE (!) than when I went in both with the hourglassing and curvature. Had high hopes and now not too sure WHAT to do...
to nycsurfer. where you in the clinical trial where you may have received the placebo?
My impression from reading the informed consent is that Auxillium's position is that any significant or long term adverse events are not due to the drug, but from improper administration of the drug.
unfortunately, I also had a negative experience with the clinical trial.
Quote from: MikeSmith0 on December 06, 2011, 12:41:28 AM
Quote from: Humorous3 on December 05, 2011, 11:49:40 AM
To recap, the total was a 30 degree reduction (started at 60 - ended at 30 = 30). So, averaging over four cycles, that's 7-8 degrees per cycle (although in reality, there was one cycle where there was no change).
Did you have any size increase in length or girth? Was this an issue when Peyronies Disease progressed for you? Or was size never a problem? Peyronies Disease has caused worse size issues than curve issues for me...so any insight would be great. Thank you.
Mike,
I never measured girth, nor did the study, so I can't answer concerning that. I did have a 4.5-5.0 cm increase in length. As the curve decreased, the length increased, which I think was a natural process.
Humorous
Humorous
Thank you for the encouraging answer. 4.5 to 5 cm is what I have lost to Peyronie's
James
You say that you have come off worse due to the trial. Could you explain your before and after situation and what process you went through?
I've lost size as well from this mess. Before my foreskin only covered half the head of my penis, I lost so much size that it covered it completely. Now that I'm on pentox my penis has regained size, straightened out, I have more "full" erections, and better erections, and my penis overall is softer, this stuff really works, I'd advise people to try it before trying other permanent stuff. My penis lost a lot of girth, and the pentox has restored this, to the point that it looks pumped all the time, like pumped with a VED, except I'm not using one currently. I notice with the pentox is makes it hard to go to the bathroom right away, and reaching orgasm is more challening, although the feeling is slightly numbed, but when you quit pentox it goes away. I'm going to stay on this stuff, and reload with another prescription, I'm getting ready to go from two pills a day to three, I've taken three a day a few times, but then I feel hot and sweaty all the time, you can tell the side effects really go up from 2-3 pills, I may push it to 4 a day at some point , but I haven't decided. Either way, the pentox has restored my size, this drug is awesome!
Comebackid
ComeBacKid
I would like to ask you: how long time on Pentox until some improvement can be seen.
James
Hi guys,
Is pentox readily available via a UK GP ?
Almost immediately I had better "fuller" erections, and a bigger flaccid hang. The softening of the penis, takes time, at least two months before you start to notice that, I imagine getting rid of the plaque, or doing whatever it is doing takes time on the drug. The side effects start immediately unfortunately, but they aren't so bad you want to quit taking it, but you do notice them.
Comebackid
Comebackid, I can attest to the same results you have described for myself on pentox. I can't even feel the plaque lump anymore in my flaccid penis. My hourglass has completely gone away, and my girth has returned. There is still a slight upward turn in my erection, but not a problem. At the base of a hard erection, there are two small noticeable "impressions". They are are two lines along the shaft that are about 2mm long, side by side. I hope they too will eventually go away. I think that is the only thing that is keeping me from being straight out as I used to be before peyronies.
My pain has gone away, but have to say I still have some pain when during missionary intercourse my wife begins to move her pelvic area forwards and backwards when she approaches climax. It really helps her be fulfilled and I do not begruge her that. She is worried she shouldn't do it, because it might be doing harm to me. But, I just immediately after sex, go into my bathroom and take about 3 Advils to hopefully ward off anymore damage.
My only treatment is pentox 3 times a day, and low-dose Cialis 2mg daily.
Combackid and restore
Thank you for the input, very encouraging
James
Restore,
Do you notice like I a different kind of pain. The peyronies pain is like an ache, I had that for years. Now that I'm on pentox a second time I feel a sharp pinpoint pain, but it coincides with my peyronies getting better. I only feel it when on the pentox and felt it before. Its random and not daily. I believe it is the plaque breaking down, or changing, or something. The "worsening" peyronies pain is more of a dull ache, I had that before I went on pentox the first time and then it stopped when I started the pentox. Hell, I don't know whats going on but my condition is improving, so thats good enough for me! I got bottles of this stuff, I'm going to "take it like candy," as Iceman would say!
Comebackid
Comebackid,
yes, your experience sounds like mine.
I wonder if the pentox will be a maintenance thing from now on. That is, I don't want to feel like I beat this thing, and then it return again at 55, or 60, or 70.
If it is a maintenance procress from now on, I'm okay with that. It's inexpensive and relatively safe.
Could participants on the Xiaflex Trial give some input to the forum on they progress, good or bad?
Thanks
James
Yeah the Xiaflex trial seems to have gone very quiet!? Any news guys? The Trial in UCHL London must have finished. There were a few guys on here participating!
I have finsihed my Xiaflex Trial III as I am sure most other in that phase have. You can read my story under "Improvement", "Suscess" Musicman. I wish more would report how they did. I did hear that there will be some kind of trial about how long the drug remains in a persons body, but don't know much about that. I do feel that the drug will come to market but have no idea when that will be.
Musicman
Thank you for the post. Your results are amazing. Hope the Xiaflex will be available soon and not cost too much.
James
Musicman,
Great to hear about your success!!
Who was the doctor that injected you?
i completed the xiaflex trial last month and the condition did not improve. Might have even gotten worse. Wish i had better news to report. Thanks guys.
After reading again carefully the topic I begin to believe and hope I am right that the successes or failures cases in the Xiaflex trial are connected to how the Xiaflex was injected and the stretching done.
I hope we will get more input from friends that participated in the trials, not too many are active on the forum.
Have somebody knowledge about when the trial results will be released?
James
Quote from: james1947 on January 30, 2012, 03:18:32 AM
After reading again carefully the topic I begin to believe and hope I am right that the successes or failures cases in the Xiaflex trial are connected to how the Xiaflex was injected and the stretching done.
I hope we will get more input from friends that participated in the trials, not too many are active on the forum.
Have somebody knowledge about when the trial results will be released?
James
Jan 2013
" Armando Anido, Chief Executive Officer and President of Auxilium. "We believe completing the enrollment of over 600 patients at sites in the U.S. and Australia in less than six months speaks to the enthusiasm in the urology community and their prospective patients for a non-surgical treatment alternative. We anticipate reporting top-line results in the first half of 2012."
I received an email from somebody asking me if there are any new xiaflex trial opportunity in New York or Chicago, cleveland areas? Any idea? I guess it's a bit of a longshot. Should the current trial be a resounding success, what's the timeframe we're looking at for availability to the general public?
Quote from: newguy on February 08, 2012, 04:39:54 AM
I received an email from somebody asking me if there are any new xiaflex trial opportunity in New York or Chicago, cleveland areas? Any idea? I guess it's a bit of a longshot. Should the current trial be a resounding success, what's the timeframe we're looking at for availability to the general public?
There are no trials open at this point. They're about to end, actually.
There's no way to know for sure about the approval date - but I tried to calculate it based on the dupuytren's contracture study. Maybe the summer of 2013...give or take 3 mos.
This morning I had an appointment with the David Ralph's number 2 (Andrology in UK) who was actually in charge of the Xiaflex Trial in London.
He said that the results of the trial were "very good" and he is certain Xiaflex will be on the market in the UK "next year".
The bad news is that he said it definitely would not be available on the NHS and when I hesitated a guess at treatment costing between one and two thousand pounds his response was "something like that yes"!
Oh and the other thing he told me was that it is not true that Xiaflex is not effective against all calcified plaque. He referred to "bone" against which Xiaflex could not be administered but that did not represent all calcification. He said subjects with any form of calcified plaque were ruled out of a trial but that did not mean they could not be treated when the drug is on the market.
Kempenstein
Thank you for the update. Encouraging that he says:
Quotethe results of the trial were "very good"
I like specially that your doctor says that Xiaflex will help calcified scar tissues also, as mine are calcified.
You have participated in this trial? If yes, what are your personal gains?
James
Hi James
No I didn't get on the trial. In fact I was very unlucky and was on it but the Ethics Committee forbade Auxilium to take on any extra trialists at the last minute.
Thanks for the info Kempenstein
James
Had my next to last visit last month w/injection for erection and exam. Not much change to report. Still @ about 15 degree improvement. Started at 45* and am down to around 30*.
The examiner reports he can't find the plaque via palpitation now.
I have noticed less of a 'crimp' in the unit when erect, but not where I'd like it to be. Guess any improvement is worthwhile.
Final visit coming up soon. Hope to find out if I received drug or placebo soon after.
BSSS
Sounds worthwhile to me BSSS.
15 degrees, or a reduction of a third, is very good surely?
I'm sure it'll be approved...even if it gives less than 100% improvement - it's better than anything on the market now. As long as the risks are made clear, like they were in the study (penile fracture, swelling, etc.) the FDA shouldn't have a problem. Actually, I think they will need to be very clear about who had certain side effects because people in the trial did have penile fractures and other problems - the FDA will know this - so it better be clear in the prescribing information. I wonder if the FDA will make them investigate why this happened. Was it the doctor's fault, something about the dose, the plaque being too thin, etc?
If we're going to end up using this, we need to be more informed & everyone's situation (i.e., penis and plaque size, plaque location) is different. The universal approach to dosing and administration was probably necessary for the FDA - but I do not think it's going to be the right approach long term to maximize benefits while minimizing side effects. A guy with a small dorsal plaque on a 4 inch penis should not get the same injection as a guy with a huge circumferential plaque on an 8 inch penis. I think part of the supposed mystery why this didn't work so well for everyone (while fracturing the penises of others). I'm not saying this is the whole reason - but I got the sense that nobody wants to talk about penis size in detail. Yes - it's a sensitive subject, but it's better than dealing with major side effects from injecting gangrenous toxins into your penis.
For example, the entire volume (not just the length) of the penis should be calculated - in tandem with the estimated size of the plaque - to create a dose. These things are so obvious in any other area of medicine. You don't give the same anesthesia to a person who weighs 100 lbs vs. someone who is 200 lbs. Actually, these things are obvious to a hair stylist. Could you imagine a study where 600 grey-haired men got the same amount of hair dye - regardless of how much hair they had or how big their heads were? And then, a bunch of scientists being shocked why some people's scalp burned and others were left with grey hair? That's how the results are sounding from this study (based on the board posts)...with people pondering why. Well, gee I wonder what the missing variable(s) could be.
Quote from: MikeSmith0 on February 29, 2012, 02:08:24 PM
Well, gee I wonder what the missing variable(s) could be.
Without having been in the study, I suppose one of the obvious variables would be the injection skill (method) of the doctor
Quote from: Luciano on February 29, 2012, 04:22:47 PM
Quote from: MikeSmith0 on February 29, 2012, 02:08:24 PM
Well, gee I wonder what the missing variable(s) could be.
Without having been in the study, I suppose one of the obvious variables would be the injection skill (method) of the doctor
Yeah that is probably an issue but unfortunately even the top docs had patients with bad side effects. It could have been a slightly misplaced injection - even from a top doc. I think the margin for error is very small - and also I forgot to mention another thing I was thinking about. A flaccid penis shrinks from cold or from anxiety & other factors - so after the injection, the penis needs to be held in a way so that the contraction doesn't cause the collagenase to affect more tissue than it should because the enzyme was injected into a stretched penis which just shrank down after the injection.
The main reasons I am talking about these issues is that I anticipate having this treatment at some point, but the side effects that are public knowledge (told to all study participants) and/or posted here - are pretty scary. There should really be a way to minimize the side effects...even if they are only less than 5% or whatever. The fact that 1 (or 2?) men had penile fractures makes me think it is reasonable to ask them to do a thorough investigation into why it happened and publish that information as well.
Quote from: MikeSmith0 on February 29, 2012, 05:16:37 PM
The fact that 1 (or 2?) men had penile fractures makes me think it is reasonable to ask them to do a thorough investigation into why it happened and publish that information as well.
Where did you read about the fractures , yes I know its listed as a potential side effect, but has it actually happened?
I remember hearing about that. Very few though.
I thought there was an updated consent form they made us sign that told us about it.... but I just looked and it only says says "of 1082 subjects who received study drug in the Duputreyn's contracture clinical trials, 3 subjects had flexor tendon rupture"
I cant find the penile fracture part... though it says it is a risk in 3 different places on the form. I think the study coordinator said there was a fracture verbally. But that's surprising bc i think everything has to be in writing. I'm not sure now...or if I am not looking at the latest form. I re-signed the consent forms about 3 times due to updates.
Quote from: Kempenstein on February 24, 2012, 01:47:08 PM
Sounds worthwhile to me BSSS.
15 degrees, or a reduction of a third, is very good surely?
I'd say it was nice to have improvement, that's for sure, but some receiving placebo in previous trials had a 15 degree improvement due to swiss cheese effect. But I, like most, endured much for that and some didn't get any improvement at all.
Had my last visit last week, no change reported. Still won't find out if I received drug or placebo yet, but office seemd to indicate there could be one more trial segment. Have no idea how accurate that is.
I think I posted this before but will again. I know many are looking forward to Xiaflex in the hopes that this is the holy grail for those who suffer from Peyronies. I had a follow up appointment with Dr. Levine a few months ago. And I asked him if he had any insight into the result of the Xiaflex study. He indicated that Xiaflex would be another form of treatment, but that it was not the answer for everyone. Like other treatments, it works for some and not for others. Levine indicated that of the study about 30% of the men who did respond to treatments responded favorably. But that the other 70% didn't see any change at all.
It will be interesting see the actual study results.
Makes you wonder if it is the swiss cheese affect ,more than the medicine?
How Levine explained it 30% working and 70% not working sounds worse then the percentages they pitched to me when I had the VIs. I believe Dr Lipshultzs pitch the VIs for 40% working and 60% not working. I know all the percentages are just talk and a perception of the individuals opinion in the end. I have to admit though its the only thing I have to look forward to that might help once this avenue is exhausted I pretty much have ran out of all options. There really isn't many options to begin with at all. I think they can tell us all the projections and percentages but in the end we will just have to see how many of us here it really helps just like we all learned over time with the VIs. I really hope and wish the very best for it because I don't see others putting this much time or resources in to a treatment for Peyronies Disease in the near future. If it is a success and it makes good revenue it will make other interested in developing treatments for us too. That would be wonderful and can only wish it to be come a reality.
Final followup visit completed, only bloods and urine this time (finally no injections).
Will be advised if I had drug or placebo in the near future, if I received placebo then I can have another course of injections with drug. (but a with a 22° improvement I am fairly certain I had the drug) and doctor reports that he cant detect any plaque (which will mean that there is no injection site ????).
Will post further information as received.
Thanks
S
saramon
Thanks for the update.
James
Saramon, what do you mean when you say that there is no injection site?
Quote from: saramon on March 05, 2012, 07:05:24 PM
Will be advised if I had drug or placebo in the near future, if I received placebo then I can have another course of injections with drug.
Saramon, did you have any size changes?
If you had swelling and/or bruising (or similar), you had the drug most likely. It is virtually impossible to have a xiaflex injection without any reaction. Swelling and bruising occurs in 73% (in the hand...the penis is probably more susceptible). Negative reactions occur in 98% of cases https://www.xiaflex.com/docs/pi_medguide_combo.pdf - page 7.
It seemed a little suspect when nurses and doctors say "some people have reactions and some don't" - in almost identical ways to me when I questioned them about the lack of any swelling...and they avoided my follow up questions with subject changes or shrugs because they only had one line rehearsed. They are not formally told who is getting the placebo, but I think they know - based on the reactions (which is one other reason the double blind is sort of stupid, because the doctors know who is getting the drug based on the reaction). Collagenase is highly toxic usually just found in gangrene...you'll get a reaction if it is injected in your penis, hand, or probably even left on your skin too long.
Fubar - with the tiny needle and brief injection technique, the placebo does nothing. There is no real "swiss cheese effect" because there is no real swiss cheese approach. The needle just goes in, releases a tiny amount of saline & comes out (making the placebo group that I wasted a year of my life in even more absurd and unnecessary). If anyone had an improvement from the placebo, it was a coincidence...due to natural resolution of the disease, I would suspect. And this is already known from other research - and again, there was no reason to waste people's lives in the placebo group (comment made for those reading from Auxilium - unless this design was forced by the FDA). Lab rats don't have busy and complex lives...people do. Going through nearly 20 visits to a urologist for penile injections during working hours for some tiny sum of money was quite frustrating to say the least, particularly since no placebo group is truly necessary here. There are also other statistical methods to analyze the data to determine how xiaflex is working - against itself - instead of vs. a placebo (e.g., hierarchical regression). Whatever, they don't care.
MikeSmith0 I agree with you 100%. We are not lab rats and your observation that in this case the placebo group was unnecessary is right.
James
I have to disagree with the statement that virtually anyone who gets Xiaflex has a significant reaction. The first injection of Xiaflex I received resulted in only the mildest reaction. No swelling, no pain and only minimal bruising.
I was also in the Open Label Trial and received 4 cycles (8 Xiaflex injections), and had no bruising, pain or swelling after 5 of the injections. The 3 in which I had bruising, I believe were due to me not holding pressure on the injection site for long enough, as each time I held pressure up until the first blood pressure check (at 15 minutes), there was no bruising.
For the guys who have gone through the Xiaflex trials and experienced there plaque(s) disappear to both there eye and touch, has any one had a ultrasound to check and see how the plaque locations show up on the ultrasound results. For instance is the plaque completely gone, is it still there but the scar just changed characteristics, or has it became so small and or thin it doen't effect the deminsions anymore etc.
Quote from: ohjb1 on March 11, 2012, 07:08:35 PM
I have to disagree with the statement that virtually anyone who gets Xiaflex has a significant reaction. The first injection of Xiaflex I received resulted in only the mildest reaction. No swelling, no pain and only minimal bruising.
My post was based on the xiaflex prescribing information on the website published by the manufacturer..stating 73% have a swelling or bruising reaction from injection into the finger. 98% have "some" negative reaction (see the link). Does the penis have less susceptibility to swelling for some reason that would make you think this will be lower than the Duputreyn's group? I am not a urologist - so I don't know. And, I had VIs - so I had some serious penile swelling and bruising (which did dissipate faster than other bruising or swelling elsewhere on the body, interestingly)
The numbers in the PDF are from a trial of thousands of injections. Your experience vary based on a number of factors like most drugs... but I also think that there are some misunderstandings how this particular drug is precisely supposed to be injected, based on the negative reactions that people have had & some have posted about.
Quote from: loyalty on March 11, 2012, 11:13:23 PM
I was also in the Open Label Trial and received 4 cycles (8 Xiaflex injections), and had no bruising, pain or swelling after 5 of the injections. The 3 in which I had bruising, I believe were due to me not holding pressure on the injection site for long enough, as each time I held pressure up until the first blood pressure check (at 15 minutes), there was no bruising.
Somehow, less than 24 hours after I made a negative post about xiaflex side effects - someone who never posted here before about anything - despite being in the open label trial - just
happened to come across my thread and was so motivated by it that he had to
create a new account respond to it. What are the odds? Pretty low, I'd imagine.
They get even lower that you claim that you only had bruising and swelling because it was
your own fault. Just too perfect... I am sure the manufacturers of Vioxx wished they could have pawned all the fault onto the patients too.
Quote from: james1947 on March 11, 2012, 03:49:09 PM
MikeSmith0 I agree with you 100%. We are not lab rats and your observation that in this case the placebo group was unnecessary is right.
James
Thanks James. I appreciate it.
loyalty
Thanks for joining the forum. Your experience is interesting.
Could you give us some more details regarding the procedure in the Open Label Trial?
Could you give us some details regarding your Peyronie's before and after the Xiaflex trial and the time table for improvement if any?
James
Response to Mike Smith - I was responding to a statment that essentially stated that any injection of Xiaflex would most likely cause a significant reaction. My first injection resulted in only a very mild action.
I was not saying that Xiaflex is w/o risk. In fact, in my case, my 2nd injection caused such a dramatic adverse event that I had to drop out of the trial.
Quote from: ohjb1 on March 12, 2012, 08:37:05 PM
Response to Mike Smith - I was responding to a statment that essentially stated that any injection of Xiaflex would most likely cause a significant reaction. My first injection resulted in only a very mild action.
I was not saying that Xiaflex is w/o risk. In fact, in my case, my 2nd injection caused such a dramatic adverse event that I had to drop out of the trial.
Oh yeah I thought your username looked familiar. I think I remember reading you dropped out - or it might have been someone else. I think a few other people in the trial had to drop out due to adverse reactions. There have also been a handful of posts by unhappy participants like "thiswontwork" and others. Are you doing better now?
Just my opinion.
What for someone is significant reaction may be to someone else mild reaction. It is more personal feeling.
I read everything on the forum and loyalty is the only one that had no any reaction. He was on the Open Label Trial so he get the medicine for sure.
Loyalty
I hope you are reading the topic and will jump in to give us some more details regarding your own experience.
James
My experience with the Open Label Trial is this -
I barely made it into the study with a 30 degree curve (as that was the minimum cut off). I recently had my final follow-up visit, and had a measurement of 18 degrees, for a 12 degree improvement (after 4 cycles). I followed all instructions, such as modelling, exactly as directed, so I was surprised that I didn't get more of an improvement (Auxillium is hoping for an overall average improvement of greater than 50% - so I would be one who will not help their stats).
Regarding Mike Smith's comments about my first post. I did not just create a new account. In fact, Mike, I sent you a PM about my Xiaflex experience on 07/29/2011, and sent a PM to another member around that time. I would have posted and sent more PM's but I was not able to get the character recognition feature to work from August until just the other day. Regarding my statement about the bruising. The Urologist and Nurse each instructed me to hold pressure on the injection site for "a few minutes", and I developed a significant bruise after that first shot. The next day I held pressure for the full 15 minutes up until the first blood pressure check (I decided to try this on my own), and found that I didn't bruise. I followed this strategy of prolonged pressure on the injection site for each subsequent shot but still had two that bruised.
Loyalty
Thank you for the answer and clarification. It makes things more understandable. As I say, "significant bruise" can be different for everyone.
You have to understand that people on this forum are very sensitive to posts and some, doing a big work to keep out spams and promotions of medications and med. manufacturers.
Regarding your improvement, you have now 18 degree, it sounds good to me. I am ready to sign with two hands for any treatment to get down to 18 degree.
How about other improvements like length and girth?
James
It's still a 40% improvement, not fantastic but not bad either. I'd be interested to know if there were any other improvements too.
I fully expect Auxilium will know whether some doctors performed better than others (obviously each Peyronies Disease case is different) but I am of the opinion in the hands of another doctor and his technique its possible this patient may have had a greater improvement over 4 cycles and same dose.
That's fine - sometimes certain things on message boards just seem suspicious to me. I wouldn't take it personally...it's just my own view of what I see on message boards, broadly...based on some past experiences. I doubt that any employee there could ever post here...or that person would be in serious trouble. Then again, what has happened with other drugs (neurontin, avandia, phen-fen, rimonabant, vioxx, etc...) makes me wonder. But anyway, I assume it'll be approved & people will be running to their urologists for it. There is no other promising treatment - even if this only provides a % improvement, it's better than verapamil or traction... and would probably work better with traction in between cycles (which wasnt allowed in the study... "modeling" isn't that effective in my opinion...since it takes about 5 minutes)
If the new forum members will read the "Off Topic Discussion Area" from the first post (August 26, 2005) forward will understand how difficult and hard work was and it is to keep this forum free of negative things.
I am new member but from reading those posts I understand the sensitivity of the forum members and it makes me sensitive also.
James
In response to questions about other changes after the Xiaflex injections -
I believe length measurements were taken, as the goniometer (the device used to measure the angle) was made of stainless steel and had ruler type markings on the arms, but I was not told what the length measurements (if any) were. I did not measure myself before or after, although it does seem there was a minor increase in length. I had no loss in girth with the Peyronies Disease and therefore no increase in girth with the Xiaflex was to be expected.
The most noticeable effect is that now I can just barely feel the plaque, which according to the pre-Xiaflex Ultrasound was something like 1.3 x 0.5 x 0.3 cm. If I didn't know exactly where the plaque was, I would have a hard time finding it now (the Urologist also said he had a hard time finding it at the last visit). After dealing with this for 10 years, I knew exactly where it was and what it felt like, and now it just feels like a slight thickening of the part of the septum where I used have what felt like a piece of matchstick.
I would have liked to use traction during the trial, but I did not as it was prohibited. I have since started traction, and hope that it will have some beneficial effect, even though it likely would have been more beneficial during the treatment.
Loyalty
Thanks for the update. Again, your results are encouraging.
Be carefull with the traction device not to make some damage. Moderate usage is the best for Peyronie's.
James
Hi Bummedout
Quote from: bummedout on March 06, 2012, 07:05:00 AM
Saramon, what do you mean when you say that there is no injection site?
Doctor told me that Xiaflex needs to be injected into the plaque to dissolve it, therefore with no identifiable plaque then there is nowhere to inject.
Probably means that I received the real thing (no placebo).
Regards
S
Quote from: MikeSmith0 on March 10, 2012, 11:08:19 PM
Quote from: saramon on March 05, 2012, 07:05:24 PM
Will be advised if I had drug or placebo in the near future, if I received placebo then I can have another course of injections with drug.
Saramon, did you have any size changes?
If you had swelling and/or bruising (or similar), you had the drug most likely. It is virtually impossible to have a xiaflex injection without any reaction. Swelling and bruising occurs in 73% (in the hand...the penis is probably more susceptible). Negative reactions occur in 98% of cases https://www.xiaflex.com/docs/pi_medguide_combo.pdf - page 7.
It seemed a little suspect when nurses and doctors say "some people have reactions and some don't" - in almost identical ways to me when I questioned them about the lack of any swelling...and they avoided my follow up questions with subject changes or shrugs because they only had one line rehearsed. They are not formally told who is getting the placebo, but I think they know - based on the reactions (which is one other reason the double blind is sort of stupid, because the doctors know who is getting the drug based on the reaction). Collagenase is highly toxic usually just found in gangrene...you'll get a reaction if it is injected in your penis, hand, or probably even left on your skin too long.
Hi Mike - I had a massive reaction from the first injection of the 2nd round, (looked like the elephant man and probably similar colour). Injections were continued. No change in length but width appeared to be better, though could have been due to the reduction in curvature)
I'm fairly certain that I received the drug, especially as the plaque disappeared.
Thanks
S
saramon with the injections did u have any changes in feeling or sensation with the plaque gone?
Quote from: agent0 on March 19, 2012, 09:51:08 AM
saramon with the injections did u have any changes in feeling or sensation with the plaque gone?
Hi Agent0
No changes in feeling or sensation.
I would disagree that there is no swiss cheese effect.
I think the research points to up to a 15 degree improvement in some who only received placebo. If that is the case, what causes imporvement? Imagination? Saline? The point of injecting is to get the needle/solution into the plaque, not in the general area.
With my latest developments, I may be one of those cases....not sure yet. But I def noticed some regression this week upon taking a levitra and getting a good erection. The curve looked much more than 30* and looked to be more back towards 45* which was my starting point.
I'll be glad to hear the results whenever we are 'unblinded.'
To All,
Here is a link to a breaking story this morning - Auxilium Soars on Solid Trial Results.
http://www.gaininggreen.com/auxilium-soars-on-solid-trial-results-auxl-aria-fm-conn/121021/
Additionally, there is a new topic on the boards. Rather than spell out all the "higher" boards to direct you there, just use this link to get there:
https://www.peyroniesforum.net/index.php/topic,2500.0.html
Humorous
from Auxilium websit - investor relations, supporting materials from webcast
potential Xiaflex release for use for Peyronies 3rd or 4th quarter 2013
Quote from: jw1441 on June 04, 2012, 02:11:48 PM
from Auxilium websit - investor relations, supporting materials from webcast
potential Xiaflex release for use for Peyronies 3rd or 4th quarter 2013
Dreams ....
Recently, there was an article in the Journal of Urology which was mentioned on this forum. The article was published in May/June 2012, but discussed results of Phase II of the Xiaflex study which ended approximately 2 years ago. Doesn't this seem somewhat odd or am I the only one suspicious about the timing?
Additionally, there is a new topic on the boards. Rather than spell out all the "higher" boards to direct you there, just use this link to get there.
I saw my urologist about a month ago and I asked him about if he thinks xiaflex could help. He began telling me how he actually was one of the doctors participating in clinical trials and he said it definitley works and completely dissolves the scar tissue. But then he mentioned how if the xiaflex is injected in anywhere else but the scar tissue it will mess up healthy tissue in the penis. Anyway i guess its just a waiting game now
omg i hope your not trolling jackwert, and i seriously hope this works with my numbness. PLEASE GOD PLEASE!
Quote from: jackwert on November 06, 2012, 12:03:47 AM
I saw my urologist about a month ago and I asked him about if he thinks xiaflex could help. He began telling me how he actually was one of the doctors participating in clinical trials and he said it definitley works and completely dissolves the scar tissue. But then he mentioned how if the xiaflex is injected in anywhere else but the scar tissue it will mess up healthy tissue in the penis. Anyway i guess its just a waiting game now
Starting to sound like it would carry as much risk as surgery (albeit with more reward). I cannot remember that coming up in the dupuytren's trial though.
No im not trolling I have peyronies disease too im 20 years old. I've had it since i was 18 and i hate it just as much as you do
I would be cautious of your doctor's statment about "Xiaflex definitely works". This could lead to the perception that Xiaflex is the cure all drug. Did it help some men in the trials.... yes. Did it help everyone... no. I had a recent discussion with my doctor and Xiaflex results. I posted them here:
https://www.peyroniesforum.net/index.php/topic,903.msg40614.html#msg40614 (https://www.peyroniesforum.net/index.php/topic,903.msg40614.html#msg40614)
underdog peyronies patient of the year call me rocky
Quote from: jackwert on November 06, 2012, 12:03:47 AM
I saw my urologist about a month ago and I asked him about if he thinks xiaflex could help. He began telling me how he actually was one of the doctors participating in clinical trials and he said it definitley works and completely dissolves the scar tissue. But then he mentioned how if the xiaflex is injected in anywhere else but the scar tissue it will mess up healthy tissue in the penis. Anyway i guess its just a waiting game now
My Uro said the same thing. He needs to locate the plaque before he can administer Xiaflex. He said it should be available within the nexts couple months though.
Did xiaflex help anyone gain back length or girth?
Quote from: jackwert on November 28, 2012, 01:13:16 AM
Did xiaflex help anyone gain back length or girth?
Not me :(
well what did it do for you?
Quote from: jackwert on November 28, 2012, 02:49:32 PM
well what did it do for you?
Nothing ! it didn´t gain neider girth or length or curvature. I think it´s as good as placebo! Xiaflex is bogus! Auxilium wants in next step rob your wife on some $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ for here cellulites. 98% of all women have cellulites that they hate. They will pay Auxilium some billion dollars to get rid of these nasty wrinkles. It´s all about money nothing else.
Sorry it has not worked for you ThisWontWork. I believe that the doctor capability have a lot to do with the improvement on the placebo group also.
I just read the article on the link posted by Doksoul, maybe we will now in a very few month if it helps or not.
Regarding:
Quoterob your wife on some $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ for here cellulites
It will not happening with my wife, I don't like skin and bones woman configuration. Like also my stake with some fat 8) ;D
James
This WILL work.
30% is not great...but they have to just figure out the best way to inject it. And, the doctor who injects it must do a good job. The FDA trial was one-size-fits all...same dose for everyone, same injection for everyone....yet penises vary and plaques vary. And, collagenase may not be good for huge plaques - and it may not be great for super thin plaques (spilling out into the area under the skin). And why did they just make 1 injection - not 2 or 3? With verapamil, the needle passed through the plaque a dozen times. I don't think they even know the best way ... it hasn't been studied. It's not easy to study.
Injection techniques will be at physician discretion in some ways, once this drug is approved...though dose unfortunately will probably be constant. Also, in the real world, we can use traction in between - which will help more.
The trial had to be restricted and prove the concept of collagenase in Peyronies Disease vs a placebo. They did that. Now it's time to refine the technique and see the academic publications come out with empirical studies about injection technique trials. I think the 30% improvement is only the beginning. The problem is that Peyronies Disease research labs have very little money (with a dead NIH too) and MDs are too busy, unless paid by AUXL. IF they had any cash, I'd throw it at improving the xiaflex injection technique...because all of their future revenue is going to depend on that.
Does anyone know how I can get into one of these trials? I live in SF bay area CA area and I have severe hourglassing in the base of my penis.
I am desperate, please help.
The trials are over. My understanding is that we are now waiting for the FDA to approve it for Peyronie's. Then, let the games begin.
By the way, I'm in the Bay Area as well.
Hi all,
I haven't posted on here in quite awhile due to frustration. I waited so long to get into a trial, only to be given the placebo. Then I had to wait almost another year before getting the real drug. I just started the first cycle with the real drug. I can definitely tell the difference in pain, swelling and bruising. There was even a "crack" during my first modeling with the urologist. My doc told me these are all good signs. He said the drug work well on about 70% of the guys in the study. Now I just have to be good about about doing my own modeling at home. I'll let you know in a bout a month or so if I show any significant improvements. I am 40 degrees bent and lost about an inch or so in length.
chop is the pain better or worse with the xiaflex ? thanks.
Chopsuey, what do you mean by "crack" and "modeling"?
Quote from: MattFoley on January 27, 2013, 02:02:05 PM
Chopsuey, what do you mean by "crack" and "modeling"?
He means when after they have injected the Xiaflex the specialist manipulates/stretches the penis. Sometimes the plaque cracks audibly. Remodelling is the term used for stretching or relocating the plaque so that it doesn't cause such a significant bend.
This may explain why many of the placebo patients saw improvement, but raises question about the effectiveness of xiaflex, since it was not alot better than the placebo.
OK, so the placebo is saline and then they manipulate the penis. And they got results like the ones in the study? OK, forget the Xiaflex, just shoot me up with saline and manipulate my penis. How much is that gonna cost?
My urologist got me into the practice's research physician and I'm now in line to get the xiaflex. My first injection is March 31 with 2nd injection and modeling the next two days.
I really want to hear from other people who have started and what I can expect. My Urologist is Dr. Bailen at FirstUrology in Louisville KY
JohnG
You may find the answers at:
Thread for Guys in Xiaflex Trial - Currently or Previously - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,1458.0.html)
James
JohnG,
My assumption is that Xiaflex injections are identical or at least VERY similar to Verapamil injections. You can search a bit on VI's (Verapamil Injections on this site and find exp erenice from several members (including myself) how have experienced these. I would suggest taking an ice pack with you to place between your legs on the way home and expect a lot of bruising for several days.
I used to use an icepack after my Verapimil injections and my PA who was administering told me not to. If I remember correctly, he said that the cold causes any excess fluid to leave the area - including the drug itself. I would check with your doc on that...
I asked my dr, Coy Carson at unc if the injections were about the same, and if i remember correctly, he said the needle was much smaller.....
did any of you guys acutally LOOK while getting your VERAPAMIL?
i sure didn't...
I had verapamil shots a year ago. No luck. I just finished my first week of Xia-Flex shots. I can tell you they are DEFINITELY not the same. Xia-Flex is far more virulent or potent. The swelling and bruising is far more extensive. Not much direct pain afterwards unless touched or handled. Ice packs, 20 min's on and 20-30 min's off for a couple hours after the wrap is removed and laying on the couch with your feet up (gravity is the enemy here) is recommended and I found helped a lot after the second shot of the week. Don't be surprised if your package turns deep purple or even black. I developed a blood blister at then injection site as well that broke on it's own. Pretty standard, I'm told. I am a survivor of terminal cancer of 12 years ago. That was very painful but nothing compares to the pain I experienced during "modeling" yesterday. Do yourself a favor and ask for a pain block before modeling. It is an option. I will definitely ask for it next time. Modeling is when the doctor takes the scare tissue and tries to break it up by hand. Oh, man! Three- 30 second manipulations. Excruciating does not adequately describe it.
For those of you who don't believe it, yes the entire treatment protocol runs about $25-30K. You get shots 2x/week separated by 4-6 weeks (for recuperation) for a total of 4 sets. I read the study. Average improvement is about 35 degrees or so. While not typical my doctor had one patient that went from 90 degrees to 10 degrees. Xia-Flex is for dorsal (plaque on top) problems. A picture in the study of what they call a 35 degree bend looks almost straight to me so I am hopeful. I am probably at 65 degrees to start. Improvement doesn't come until nearer the end of the treatment. I don't check this site at all so if you have a question you can email me at paulmrt57@gmail.com. I will try to answer.
PMRT
Even you don't check this site at all, thank you for the update.
Maybe you will find time to give us an update regarding the results when finished the Xiaflex sessions?
It will help other Peyronies sufferers to chose this way.
James
PMRT I wish you they best. Please keep us posted on your progress.
Dear Carbonlib
I have an appointment with Dr. Carson tomorrow. How do you like him?
I have a nice story about recovering from Peyronie's mostly from alternative approaches. I shared it on the list a few years back. . a combination of Bill Zarick, email deleted by moderator, a bodyworker, siddha yoga healer--60%, chris spivey (VED and iontophoresis--verapamil)---Birmingham urological --20%, and Paul St. John, body worker in St. Petersburg, FL--10%.
I still have the curve and wondering whether to try to improve that. Erectile Function not only came back from the dead but really improved even compared to pre-peyronie's. Also lots of good exploration of sexual-emotional satisfaction has happened. Is there a peyronie's club in the triangle? I'm new to the area. Gnosis
I see Dr Carson as well. I have seen him for some time. I enjoy him as a person. I have great respect for him as a healer. I am sure you will do well with him also.
gnosis & chapel hill
This topic is for Xiaflex trials.
Why you are hijacking the topic?
James
It has been about three hours since my first Xiaflex injection. Compared to the 8 ml injected for each of 12 Verapamil injections, this 0.25 ml was nothing. And, unlike with the Verapamil, it was not necessary to precede the Xiaflex with lidocaine for pain reduction. It was only slightly uncomfortable when he pushed the needle into the thickest part of the plaque.
I was not expecting the extensive preliminary examination. There was the usual physical exam by the doctor, followed by a trimix injection to produce an erection (it helped to look at soft porn books), and then an ultrasound exam (by an attractive female tech!). I needed another trimix injection before they could get a good angular measurement (50 degrees upward) and mark the point of maximum curvature. Then there was another injection to make the erection go down. Finally, the Xiaflex was injected. Today, I felt a bit like a human pin cushion!
I left wearing a snug wrap of self-clinging elastic bandage (co ban). That is becoming a little uncomfortable. I am unsure how long I will have to wear it. Perhaps the take home material has some information.
My next injection, without the extensive work-up, is in two days (Wednesday), with modeling two days after that (Friday).
I will try to scan the take home materials and post them here later this week.
My insurance (BCBS PPO) covered the procedure at 80%. My co-pay for today was $85.
Thanks for the update, Brooksbro. How long did it take for your insurance to be sorted out? I was told 4-5 weeks and I'm nearing two months now waiting for the okay.
It started in mid-February. See this post for more information.
$28,000.00 for Xiaflex injections... - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,4714.msg54870.html#msg54870)
The Xiaflex provided patient instruction sheet is attached.
Thanks, Brooksbro.
Interesting that they have manual penis stretching as part of the treatment in the handbook.
It's helped me tremendously, though it's no cure, but what is?
NeoV
BrooksBro posted the patient instruction sheet, two posts bellow.
Maybe is written there something regarding manual stretching.
James
SECOND XIAFLEX INJECTION on April 9 2014
I had my second injection late yesterday afternoon. The urologist quickly examined me and said the bruising and swelling were typical. He then said "it is working." I suppose he could feel the plaque softening from the first injection. I was extra tender at the site of the plaque.
The second injection was a little more painful than was the first, but it was tolerable. They use a 25 gauge needle, and the injection is only 0.25 ml, so it does not take long or require pain medicine. They again applied gauze and wrapped it with co-ban, telling me it was OK to remove it after 2 hours. When I removed it about three hours later, it was much more painful than I remember it being after the first injection. It was painful enough that I took some Vicodin that I had previously been prescribed. That let me get through the night well enough. I took more this morning and applied an ice pack for a while. It is still very swollen and uncomfortable, but the pain level is low enough that I expect to make it through a day of work. I will apply ice more tonight.
I go back late Friday for my first modeling. The docs said they have another handout on modeling that they will give me to follow for the next six weeks. When I get that, I will post it here.
I am beginning to understand why they administer this in "divided doses." If it is as potent as it appears, giving all of it at one time would be more than most men could tolerate.
BrooksBro
Thanks for the detailed update.
Let us know how the modeling was Friday.
Wish you a very successful treatment.
James
Ouch! Hoping this is all worth it for you! The modeling sounds awful if I'm understanding the process correctly.
Sending hope and God's speed in you complete recovery!
Good luck and thanks for sharing!
Wishing you the best. KAC
The first modeling procedure was free of discomfort. It was nothing. I was reassured again (is that redundant?) that I got "the real thing" and not a placebo, based on the swelling, discoloration, and pain that I have been feeling. Not everyone has pain (I do!), but the swelling and discoloration are characteristic of the medicine working.
If you want to know a whole lot more about the injection procedure, go to the website that Xiaflex has developed to help train physicians - Xiaflex REMS - Xiaflex - collagenase clostridium histolyticum (http://www.xiaflexrems.com/)
As for the cost, Friday I was told that the medication is distributed as a "kit" which contains two vials of the medicine, and two vials of the diluent. The full price for one kit (two injections) is $3,000 (US). Each person is different, and they may require 1-4 injection series (two injections per series). The doctor's fee for performing the injection is highly variable, and I don't have any data for my own experience yet. I did have an $85 co-pay for each of three visits last week. Depending on the physician, they may or may not, perform an induced erection and ultrasound before each series. This helps them to identify the plaque location, and the point of maximum bend. If they do this before each injection series (6 weeks apart), then there will likely be higher costs for these procedures and the medicines used.
I received a letter from BCBS (TX) saying that pre-approval was not necessary, although this was done by the medication distributor (one of several regional distributors in the U.S.) before shipping the medicine to my physician. It further said, injections for Peyronies are a covered procedure.
BrooksBro
Again, thank you for the update.
Let us know if you see some improvements.
James
I was diagnosed with peyronies 2 1/2 years ago. I had verapamil injections a year ago with no Improvement. I began xiaflex injections last Thursday. Had the second injection today. I was very surprised that the swelling and bruising was so severe. Currently I have a 90 degree bend -
Timdvm
Thanks for the update and keep us updated.
Let us know also where you got the injections.
I am not surprised regarding the bruising. Read down the topic, you will have many posts mentioning bruising.
James
The swelling is much improved today, but still very sore. Entire length of the shaft is black and blue. I got the injections from a urologist in Edmonds Washington - he is part of the drug release program.
Update. Swelling is going away, the bruising resolving. I started the remodeling three times a day. Does anyone have any advice on how much traction tension should be applied? Or what has worked for them?
Timdvm
Good to read that you are better.
Regarding traction, do not increase tension over comfortable feeling!!!
James
I received my Xiaflex treatment this week. It was set up to start on Monday and Thursday for the injections with modeling to occur the following Monday. Today is Saturday, and I go for modeling on Monday.
First of all, the first injection was painful, but I powered through it. It caused swelling and caused my foreskin to completely close off the end of my penis where I had to forcefully had to pull back the skin just to uninate. Additionally, I received heavy bruising just above my penis in the fat pad. I was unable to do the required pulling/modeling due to my penis being trapped within my foreskin.
I contacted my Doctor on Tuesday afternoon about the swelling, and he said to use warm moist heat on the affected areas. He said to not use ice as it would affect the drug. So a heating pad felt good to the painful areas along with a hot shower. Additionally, I took Ibuprophen which helped dull the pain.
By Thursday the swelling had gone down somewhat. I went back to my Doctor who said the side effects were normal. He then examined the plaque area and said if felt softer than before. He began to do some modeling (breaking up the plaque). Afterwards, he did the second injection. I had the same symptoms as Monday, but I was more prepared for the pain and inconvenience this time. Again, struggled to try and urinate through a very closed foreskin hole.
By Saturday, the swelling has subsided, and i am able to try to model the plaque area somewhat. Will let you know how Monday goes.
As far as approval, My insurance company (United Heathcare) approved, and I paid my copay of $40.00. I will have to wait until the claim is processed to see if there are any additional costs. They sent me a letter saying pre-approval had been granted, but they did not have a physician in my area (Atlanta, GA) on their list who administered the drug. US Bioservices is company who sent the drug. I had to do a phone pre-screen with them. They also told me I was pre-approved by my insurance company, and I would not have any costs for the drug from their perspective.
Lastly, my physician is Dr. Steven Morganstern. He has been wonderful and has done several treatments to help allieviate my Peyronnies Disease. We tried Endo (CO2) treatments along with changing drugs/vitamins and diet. He has monitored the Xiaflex trials and felt it would hopefully correct my problems which is mostly at the top with a 35% to 40% curve.
tlyle0
Thanks for the information.
Could you give us some more information regarding Dr. Steven Morganstern?
I would like to add him to our doctors list.
Information like:
Address, organization (clinic, hospital).
Expertise.
Contact info.
James
Hey TlyleO
Can you describe more about how the doctor did your remodeling. It sounds like he did more than simple traction and stretching.
Timdvm
Below are the links to Dr. Steven Morganstern's practice. Dr. Morganstern has published several books, been on CNN, done several television shows, and provides training to other physicians on Urological and men's health issues.
Morganstern Urology, P.C. & Men's Health Center - Atlanta, GA (http://morgansternhealth.com/)
Atlanta GA Urologist | Atlanta Urology | Urology in Atlanta GA |404-352-8220 | MorganStern (http://morganstern.com/atlanta-urologist-md/)
Peyronie's Disease: Treatments, Penis Curvature |Atlanta Urology | MorganStern (http://morganstern.com/peyronies-disease-treatments/)
For Timdvm, he basically did what you said which was simple traction and stretching. But I did notice that he used his fingers to squeeze the plaque section to somewhat break it up. He did not apply a lot of pressure. It was more like softening it up gently with his fingers. However, the main modeling will occur on Monday. Not sure yet on what to expect other than more temporary pain. At this point, I am ready to see if this works and move on with my life as most of us are.
tlyle0
Thanks for the info regarding Dr. Steven Morganstern
James
Thanks for sharing everyone. As more and more people are getting this done every day it is great to hear. I should be getting this done within the month now that the 3+ months wait on insurance is over.
This does not seem pleasant but I really don't care at this point since it seems like it's working.
Today marks two weeks since my first Xiaflex injection. The "bruising" (not painful, just ugly) is all but completely gone, as is the swelling. Two spots continue to be tender to touching, one of them is where my plaque USED TO BE. I can no longer feel the same plaque in that area, but it is still a little bit painful when I feel there for the plaque. I continue the 3X daily stretching. Just two more days until I can decide if the pain has decreased sufficiently to see how it works. ;D Just last night "the wife" was asking me how I was feeling.
If all goes well with sex later this week, I am going to think seriously about cancelling my scheduled second injection series (mid-May), before they order the medicine from the distribution pharmacy.
BrooksBro
What about the symptoms?
What you had and if, all gone? (like shortening, girth lost, bend, ED)
James
[Full quote removed]
Yeah this what we all want to hear about haha
Update on my third visit with Dr. Morganstern. We did the modeling today which bacially was what he did last week after the injection. He spent about 5 minutes simply pulling my penis length wise numerous times with gentle pulls. Dr. Morganstern again said we don't want to over do the modeling exercises to prevent any possible hemorrhaging. He also said that the plaque is softer than before down the length of my penis, but he did observe that plaque at the base was still there. He is thinking that the next treatement in 6 weeks will address that plaque as the injections last week focused on the plaque down the length of my penis (my plaque is at the top of my penis).
I did share that over the last week since the 1st injection, I did get a morning erection just as I did when I was younger. This had not been occuring since the Peyronnies started.
He then reviewed my blood work and advised me that the bruising and swellwing will continue to subide. Lastly, he did say he wanted to see me again in 2 weeks. He wanted me to continue doing the modeling exercises over the 2 week period. He wants me to try sex again in 2 weeks to see if there are any improvements.
I shared that I posted his information on this blog. He was happy and would welcome any calls/questions to his practice about Peyronnies. He did tell me that his approach is to do Endo Stimilation treatment/drugs at first before moving to the injections and sonic treatment. The Endo Stimiliation did help me by reducing my fat pad and opening up my urethra for better urine/stream distrubution. It did help with reducing some of the curvature, but he decided that Xiaflex would be the next best course of treatment. Again, I am doing this to get past all the problems I have faced with Peyronnies.
tlyle0
Your results are encouraging.
Let us know how was the sex also.
James
Is anyone taking Neprinol AFD along with the xiaflex injections? I have starting taking 4 capsules twice again after starting the xiaflex injections.
My bruising is gone and I can feel the "stretch" and pull in the plaque area as I do the stretching exercises 4-5 times a day for 30-60 seconds. Have a remoldeling office visited next Tuesday.
I posted six weeks ago after having my first set of injections. Last Friday I finished my second set....injections Tuesday and Thursday, and modeling on Friday. So that's four shots total so far. Before posting this I read several of the posts below it. Many people report similar things I am going to report. One or two are different. First, my doctor is not against cold packs after the shots but I will ask him more about this next time. I did not apply a cold pack on the very first shot. I work from home. I came home after the very first shot with the tight wrap on. After three hours I removed it but continued to sit in a chair and work. The bruising and swelling that occurred a few hours after the wrap came off was very significant. It took a few weeks for it to go away completely. THIS time after the first shot on Tuesday I came home, laid on the couch and used a cold pack on for 20 minutes, off for 20 minutes for three hours. Next day? No bruising or swelling whatsoever. I did the same thing two days later on Thursday. There was some bruising and swelling but when the doctor looked at it on Friday he said: "ok, I'm a believer in the cold packs". Elevating your legs is important. Side issue: When the doctor applies the tight wrap, if he does not wrap the head of penis it will swell tightly with blood and every minute you wear that damn wrap after the anesthesia wears off will be very painful. TELL HIM TO WRAP THE HEAD AS WELL and the 2-3 hours you have to wear the wrap will be literally comfortable. No question about this. Don't forget. You will regret it. Modeling: I found modeling (the first time) without the anesthetic block to as painful as having a tooth pulled without Novocain. Never again. This time I had the block. Aside from no pain the doctor was able to perform the modeling substantially longer than the first time, which I take as a good thing. I swelled very, very significantly within an hour after the modeling and the bruising was also very significant. Tender to the touch as well. I came home and laid on the couch again and iced it on and off as above all day. That helped a lot. Now three days later I am still swollen but frankly I couldn't care less. I cannot say I had any improvement after the first round......ok, maybe a little bit but insignificant. My doctor was not surprised and said most improvement happens towards the end. I have about a 65 degree bend. He says there is better than a 90% chance we will improve that by half.....good enough I suppose. I saw a picture of a 35 degree bend and it looked more or less straight to me. More: Doctors are required to follow a strict protocol with administering this drug but later they are usually given more latitude to try different things. There is an excellent chance "down the road" that the FDA may open this up to additional "trials" during which doctors can experiment a bit with different techniques. Free medicine will be made available. I am already on the doctor's list for that time whether it is 6 months or 6 years from now. I will probably post after my 3rd round in 6 more weeks but I will not be on this site before then. Email if you wish to paulmrt57@gmail.com
A few question for those using the Xiaflex injections:
How long are you supposed to refrain from sex after receiving your injections and modeling?
Have any of you had sex since you went through the procedure?
Can you describe what it was like? I am fearful that the Xiaflex might weaken the penis and make it more at risk to further injury?
I can tell you that Dr. Gelbard, my doctor in Burbank and one of the main doctors in the trials, told me that of the 3 men who suffered a penile fracture two admitted to having sex before the two week waiting period post injection was up. So I guess you should wait at least two weeks. But I'll probably wait a month just to be safe.
Three weeks after my first Xiaflex injection, all the "bruising" and swelling is gone. If there is any of my plaque remaining, I have great difficulty feeling it. There is a small tender and red area where the plaque used to be, but the plaque itself is no longer there. The curve that I had has been reduced. I still have some hour glass effect. I will continue the 3-times daily stretching and holding for 30 seconds for at least the next three weeks.
I have used the smallest cylinder of a 3-cylinder VED to produce a pull (as in the VED protocol), and that seems to be more effective than manually stretching.
I still have ED, in my case, primarily venous leakage. Blood inflow is good enough to produce an erection, but retaining it firm and long enough for satisfactory sex is the challenge. I don't know if, or how much, that may improve in the future. I will continue taking 100 mg viagra, and then using a vacuum pump and constricting band for penetrative sex. I don't seem to need that for masturbation, either by myself or when my wife does it for me.
Overall, I am pleased with the result. Xiaflex may not be a magic bullet for everyone, but it surely seems to be the medicine that I have been waiting to get for my Peyronie's since 2009.
I called my doctor this week and cancelled the appointment for a second injection series, because I don't need it.
When I get the final benefits statement from my insurance company (BCBS TX PPO), I will provide that information.
BrooksBro, if you can no longer feel a plaque after the Xiaflex shot - that is tremendous! Have you ever had a scan done to show the plaque? Or do you plan to have one done to show it (perhaps gone) now?
Really excited for you. This is good to hear.
Nemo
I had no swelling or bruising after first an second injection, which were 3 days apart. After about a month of modelling there may be some subtle improvement but it is hard to quantify/measure. My second cycle with Xiaflex starts next week. This will be 2 more injections 3 days apart. Hoping to see some more notable results. Good luck to all.
Over the past five years, I have had at least three color Doppler ultrasound scans. The last one was the day of my first Xiaflex injection, so the docs could visualize the plaque. Since I can no longer feel the plaque, I do not think there is any need to have another one done.
The ultrasound itself was not uncomfortable at all. That is, if you are comfortable with a 20-something year old, attractive, female ultrasound tech, and four male doctors looking at your cock. In some ways, it reminded me of working my way through college as a male stripper. ;)
The most uncomfortable part is the multiple injections to produce a rock hard erection and to reduce it after the scan. Laying on a table with your pants off and looking at porn books, trying to get an erection was not uncomfortable, just a little awkward. That would have been better if they had turned the lights down. ;D
BrooksBro
Sounds a real Peyronies treatment. Not to feel the plaque anymore is great.
QuoteThat would have been better if they had turned the lights down.
They will have to change the book to a movie. 8)
James
Update - I am about three weeks post xiaflex injection. The plaque where the xiaflex was injected is soft and it almost feels "normal". My plaque is quite long down the length of the shaft so I will need more injections further down the plaque.
During erections I see much less of an hour glass at the original site and the bend is definitely less when I stand up. It is still "weak" at the point of the bend still giving me a "floppy head" if you will but I am seeing improvement.
I know the xiaflex is removing the scar tissue but will not replace the elastic part of the tissue that was damaged so I am curious as to how much length and girth I will restore - if any.
I am also taking neprinol daily which is designed to control scar tissue and fibrin. Doing stretching and straightening multiple times a day for between 30 seconds and a minute.
This is very good news, guys. An injection that is actually reducing/softening/shrinking scar tissue is what we're all looking for. Your point about not restoring elasticity is well taken though. Still, seeing an hourglass reduced - to any degree - must be very exciting and give you a good feeling.
Best,
Nemo
I made the topic sticky that it will remain on the top so we can follow more easy the Xiaflex injections results.
James
I'm currently a few weeks post-Xiaflex injection and so far the treatment seems kind of benign. There hasn't been a huge change IMO. There seem to be two major areas of plague (or whatever). One is on the topside of the penis and I call it the flying saucer as it seems round. This is where the injection was placed and there is maybe a slight reduction in size.
The 2nd and the culprit of most of my problems is on the underside and feels like a piece of cartilage and is about 1 inch long. It bends inward fairly easily but not backwards. It's the location where my curvature is and seems to be the point where blood stops flowing as well. My penis has shrunk from about 8.5 to about 7.5 and only gets fully engorged if I'm taking Cialis or something, which I hate due to the headaches.
My urologist says he can't treat what is underneath but I wonder if others have this same issue and have a way to treat? Does applications of lavender oil help? Are there other topical or oral solutions I can use?
Thanks,
John
JohnG
Regarding:
QuoteMy urologist says he can't treat what is underneath
You need a second opinion.
James
I believe the deal with Xiaflex is that it doesn't work well on plaques on the bottom side of the penis - my guess is this is so close to the urethra, it makes puncture a danger, but I don't know this for a fact, am only surmising.
Nemo
I recently went to the mayo clinic to get reevaluated. If anyone lives in MN Dr Landon trost is the guy to see and the only one in state that does the injections as he was part of the trials. My current curvature is 20 deg right, 10 deg down, and rotation of 25 deg. Dr trost is willing to give it to me off label and my insurance approved it. My question is how he described the injections. He calls the procedure a chemical knife. He said it's not actually injected into the plaque but above and below. This injection is supposed to create small tears in healthy tissue near the plaque so that the tissue can stretch more and straighten the erection. This tearing is replaced by new healing that could turn into new plaques. If the injection was into the plaque then this area would have to be replaced with a graft possibly. He is not against injecting into the scar, as mine is not calcified, but described the procedure as above. He also thinks the rate of fracture is 2-3% and there will be a lot of lawsuits down the road from side effects including possible new scars from the procedure making peyronies worse. (*&()*&)(*&)(*&)(*&. Can't post the link cause the forum keeps renaming the letters P D to peyronies disease. Here is how to find it. Google "xiaflex rems training guide" and its the second link. Look at pg 16 and 19 question 6.
-has anyone had a similar explanation given to them?
-aren't the injections suppose to be in the plaque?
Thanks jesse
I had 8 injections of Xiaflex as part of the Auxilium phase 3 trial. The Urologist who gave each of my injections, pushed the needle deep into the thickest part of the plaque and injected the Xiaflex slowly along the needle tract as the needle was withdrawn. He injected from different angles and even different sides through the course of injections. He described the effect of the Xiaflex on the plaque as being like "battery acid" and is meant to dissolve the abnormal collagen that makes up the plaque. I would be very reluctant to allow a doctor to inject the Xiaflex into the normal tissue above and below the plaque as you describe.
Got my injection 1 of cycle 1 today.
The Urology Center of Colorado (TUCC) in Denver.
Fully covered by Cigna. Approval process took about 6 weeks. Auxilum Advantage worked with Cigna, and US Bioservices provided the drugs (they are the sole pharamceutical distributor, is my understanding).
About 6 weeks ago, they did ultrasound to assess calcification (very minor). Also measured blood flow to penis, which was healthy. Measured curvature at 80 degrees, upward. Large placque area.
Administration of xiaflex is quite uncomfortable but not painful. About 4 hours after injection, started to develop minor bruise. Now, about 8 hours after, appearance is very bruised, and it feels like it. This is what the doc told me to expect. And a sign that the right things are happening regarding placque breakdown.
Injection 2 / cycle 1 on friday.
Then a session to practice modeling (manipulating penis to further break up placques) on monday.
Then cycle 2 in 6 weeks, etc.
TUCC was part of clinical trials. Had very good results in trials, and very good results since drug was approved.
Very excited. I'm 46 years old, have suffered from Peyronies for 5 years. I want my pecker back.
(I took a pic, for the record, but can't figure out how to include.)
Are there any residents of California who have been approved and begun Xiaflex injections? If so what part of the state, when did your Dr. Submit the paperwork to Auxilium and the insurance companies and how long did the process take?
Dr. Gelbard's office in Burbank submitted my paperwork on Feb 12 or the Monday after. I'm nearing three months and the Dr.'s office tells me it's still pending. Their reasoning is that one rep in southern California is handling hundreds of cases. I'm happy to hear some guys in the forum are getting approval in as little as three weeks. But I m frustrated my process is taking so long.
Colorado
Thanks for the update and keep updating us.
I merged your topic with this one that all the Xiaflex experience will be concentrated in one place.
Wish you very good outcome.
James
Has anyone had Xiaflex with the plack/scar being located on the underside of the shaft?
I have a string-like scar 1 millimeter from the urethra and therefore probably not a Xiaflex candidate.
Anyone see my question regarding injections on reply #527 besides loyalty? Thanks for the response though. I thought about starting a new thread but they seem to get merged and lost here.
thanks jesse
I continue to post because I think I am probably one of the first to be this far along in Xia Flex treatments. Again, my doctor participated in the study trials with 13 patients. I am near Boston.
Tomorrow marks two weeks since the end of my second weekly session with Xia flex so I am half way through. As mentioned in my last post the modeling was quite rigorous and I swelled and bruised a lot. I got off my feet within a few hours of the modeling and spent the day on the couch icing it on and off for several hours which helped with the swelling and bruising. However now two weeks later I still have a lump that is best described as the top 25% of a golf ball on the top of the shaft, slightly off center to the right that isn't going down. It is not particularly painful but it can be a bit sore at times. It is a bit smaller in the morning and larger at night obviously due to blood pressure, gravity, etc. The size and the fact that it is not going down was very concerning to me. Since I am going away for a couple of weeks starting next week I decided to see the doctor yesterday. He examine me thoroughly and said it was perfectly normal. He has 42 men going through Xia Flex treatments right now and several have lumps larger than mine. He said the lump would probably be there a long time....perhaps even through the next treatment but with time it will go away.
And no, I don't see any marked improvement in curvature but with a lump like this A) erections aren't exactly what I want right now and B) one wouldn't expect it to straighten with a big lump anyway. However it does seem as though the massive plaque scar is now soft sponge....or something akin to that. It is hard to tell because the lump is big and pressing into it causes a pinching-type pain. The doctor says "let it be".
I wish he had told me about this lump possibility so I would not have experienced such angst.....again, another reason for my post. Also, some posts say their doctors are against cold packs. I asked my doctor about that and he said he could see why some doctors would say that....medicine should be within certain temperature ranges. However he does not see a problem with the Xia Flex. Still, there is a national conference next week he is attending and he plans to bring up the question. I told him to leave my last name off his Power Point Slides.
Down below someone posted pictures of Xia flex gone wrong.....or something like that. I refuse to look at those pictures and I suggest you don't either. What good does it serve? Either we stay bent or we take the chance, right? email me at paulmrt57@aol.com if you wish. I will try to answer.
PMRT
Thanks for the update. If other forum members will have similar problems at least they will now that they are not alone.
I suppose also that the doctor know what he is saying as you have written that he had 13 people in the trial and now 42 man.
We all hope that this treatment will give back length, girth, solve ED problems and straiten out the curves and dents.
Regarding the pictures showing that something gone wrong, I think it is good that people posted them, we can know that not everything is perfect.
Keep updated us, I wish you excellent results from Xiaflex.
James
To Loyalty.
I apparently did not work this web site correctly and did nothing more than return your original comments. My doctor does not have me apply pressure to the injection site but immediately wraps the entire length of the shaft tightly in stretch gauze and an ace bandage for no less than 3 hours. Would you be so kind as to email me at paulmrt57@gmail.com? Thanks in advance.
When I received my first series of injections the doctor didn't apply pressure or wrap the shaft. The first injection I had severe swelling and bruising which he said was normal. It was almost gone by my second injection 4 days later. My second injection resulted in minimal swelling and bruising.
I will have to ask him why he doesn't wrap the shaft afterward. I am seeing some improvement. The plaque at the injection site is gone - I can't wait to start the second series on the remaining area of plaque and see what happens.
In my first series of Xiaflex injections I felt nothing, no bruising and no swelling. Also little or no improvement, although plaque appeared to be softer. This week started second series. First injection had small bruise, but most notable the next dayI felt plaque beginning to break up, no longer a solid mass. Second injection resulted in significant bruising and swelling, but not very painful. I think this stuff is working. I will report progress as noted. Good luck to all.
Most of these updates are very encouraging, although a little frightening with the bruising, swelling and remodeling! Yikes!
Thank you all for sharing and all the best to all of you!
My Doc actually told me that the guys in clinical trial with most bruising actually showed greatest improvement. No pain no gain I guess. My swelling is practically gone after 24 hours but purpulish bruise covering the area above the plaque site. I am not concerned at this point but if it gets worse I might be. This is an anticipated side effect.
Wish to all the Xiaflex guys excellent outcome and keep updating us.
Can update us how the results are regarding ED?
Also my question remain what is helping most:
The stretching/modeling or the injected Xiaflex itself.
We will never know I suppose.
James
9 days after completing first set of injections for me. No improvement in erectile quality or curvature yet. Disappointed, but still a long way to go, I guess.
Am currently in line with Dr. Lue for Xiaflex treatment -- and have been pre-approved through insurance (his office seemed to be in a rush to "get me in now!" and I had to back them off so that I could talk about it beforehand). I am seeking others who have already had this treatment (actual injections) specifically with Dr. Lue -- so have you, and if yes, what have been your results so far? I see him tomorrow for a lengthy discussion on what I can expect, and what all is involved.
I don't know about any forum member that made Xiaflex injections with Dr. Lue but:
*He is one of the best Peyronies specialist so you are in good hands.
*You have time to read this topic (11 pages) until tomorrow to understand what and how Xiaflex helped other forum members. :)
James
Just back from my visit with Dr. Lue (just a visit, not the actual procedure yet, not by a long shot) and a few things I should point out (which I also pointed out to him, and he appreciated):
1) I have an undergrad degree in molecular biophysics and biochemistry from Yale, so am NOT a medical doctor, but was well qualified to become one if I chose that path, and as such, was able to understand to a much greater degree the science behind Xiaflex
2) I am NOT in my 20s or 30s, and so my desire (pun intended) to get this fixed is not as strong as it would be in that demographic, and
3) My wife of 19 years died suddenly without any warnings ~ 3 1/2 months ago, so I have more pressing things to attend to, physically and mentally, than this at this exact moment in time -- and can afford to wait, having been pre-approved through insurance, so it's totally up to me as to when to have this
That said, I would rather (selfishly) have others go ahead of me and allow folks like Lue "practice their craft" and evolve the entire protocol surrounding this procedure (Do we use wraps or not? Do we use cold packs or not?...you get the picture, as they will continue to learn what details add value, and which do not, or detract) -- so feel free to step ahead of me in the line.
Lue shared with me his technique: use small amounts of the collagenase, injected with the smallest needle that won't break off (which is a good thing, I think) to essentially "chip away" at the plaque body, rather than try to cut through it -- which makes sense, "less is more", "err on the side of caution", "take incremental steps" -- and then use modeling (aka physical manipulation) to "snap" through the plaque body at the weakened areas, much like (my analogy) one finds it easier (and more precise) to tear through a piece of paper that has been pre-perforated.
He confirmed that he is injecting into what I would describe as a black box (he knows with general intelligence where the plaque is based on ultrasound, etc., but can't get real time feedback or visual confirmation that the needle is exactly where he wants it to be) -- which also lends credence to the use of small amounts.
I have read elsewhere that the type of collagen plaque that forms in the penis is biochemically different from more general, naturally expected collagen in the human body, and that the collagenase that is Xiaflex targets only that type of collagen, so if true, that would be another safeguard.
I intend to bring up to him through e-mail follow-up whether there is any work being done to "robotize" the technique of injection, since that appears to be the Achilles heel (again, pun intended) of this procedure -- the need to take your best shot (another pun) and jab where you think the plaque body is.
With a robot, one could conceivably chemically induce (and sustain for some time) an erection, strap the penis in a fixed, immobile harness, use real-time ultrasound/imaging with external markers to calibrate for on-going, minute movement, and see the target in real-time, instructing the robot to insert the needle along a programmed path precisely to the target area and deliver the goods in a desired sequence.
After all, they do that for hair transplants now, why not drugs?
Old Grey Guy
oldgreyguy
Thank you for your deep inside regarding Xiaflex.
It may help others to decide if, when ad from whom to get this treatment.
James
Hey everyone
I started my second round of Xiaflex injections today. My second of the series is on Friday. Not nearly as much bruising or swelling this time and I am 9 hours post injection. The pain during the injection was intense.
I have seen some reduction in my curve and the hour glass shape since starting 6 weeks ago. My erections seem firmer and I am happy with things so far. I am just hoping to regain some of what I lost and had before getting this awful disease. I am still taking anti oxidants, omega three fatty acids, acetyl-L-carnitine and neprinol every day. The doctor told me to stop the stretching and straightening exercises for until a few days after the second injection
Now in process of scheduling my third round of injections. I previously mentioned swelling and bruising after 2nd injection of second round. Swelling was gone in 1 to 2 days. Bruising went from dark purple at day 2 and gradually faded to red and was gone by day 7. Like Timdvm I believe I am seeing some reduction in my plaque, hourglassing, and angle of curvature. Good luck to all with their treatment!
Question for all the guys here-
In terms of pain and discomfort, do you feel it's possible to return to work after your appointments? For example, if you have a round of injections in the morning can you then head into work?
Thanks,
Roy
My age is 64 male
Dr. Lue at UCSF has scheduled me for 4 sessions to be treated by Xiaflex starting in July 2014
Peyronies Disease
Tried Pentoxifylline Tabs 400mg for a year or more
Have insurance
Not dealing with any of the psychological effects but there are some
I am married but no intimacy
Reading the post seems to make me uncertain of moving ahead with this process
CVA California
Dr. Lue is one of the leading Peyronies experts in the world.
From this point of view, you are in the best hands possible.
Regarding Xiaflex treatment results, I think that the majority has/had good results.
In any case, this is the only FDA approved treatment for Peyronies.
James
Hello Roy,
I can only speak to my experience - but the actual injections were extremely painful but went to a dull ache after a few minutes. I was able to go to work and even the gym later that night without any issues and only Tylenol
I will say this - they give you an injection to cause an artificial erection to identify the point of maximum curve and find the spot they want to inject the xiaflex. I had engorgment and was basically erect for a few hours after the treatment once the pain subsided. That was me of course, but depending on your work, make sure you are able to sport an erection while working without causing yourself any issues
First, many thanks to the creators and moderators of this forum. My Doctor didn't do much to prepare me for the potential post injection effects, and I was freaking out last night until I found posts here regarding the swelling that turns out is pretty normal.
I am 53, with 45% curvature on top caused by trauma around 2 years ago. I am able to function sexually, but it is sometimes uncomfortable and can be painful if the erection is too full. After oral medications and time didn't make it go away, I decided to take xiaflex injection treatment. I am in Florida.
I had my first xiaflex injection last week, after which everything felt and looked normal. My Doctor told me I could have sex if I wanted to. Thankfully for a number of unrelated reasons I was unable to, as the Drug Rep told me before my second injection that having sex afterward could be very dangerous.
I got the second injection yesterday. The Doctor was more aggressive, really pushing the needle into the plaque area and with considerably more pain than the last time. He did not wrap, model or do anything other than giving me a brochure outlining stretching exercises I am to do 3 times a day until my next series in 6 weeks or so. Nothing about keeping feet up, ice packs, etc.
So I went about my normal day, sat at my desk, worked, ate dinner, feeling a bit of soreness but nothing remarkable, then I went to pee and discovered what looked like my penis trying to swallow a golf ball. The swelling was on the right side and below the injection area, dis colored, and scary looking. Needless to say I freaked, especially after all of the warnings the drug rep gave me about ruptures caused by sex. Even though I hadn't had sex, I wasn't sure if this was one of those ruptures or hematoma or whatever.
The on-call Doctor was worthless, and I was seriously considering the emergency room, when I discovered this site. I'm not sure how I missed it during my previous research, but it was a HUGE relief to read the posts of others (especially PMRT's posts, which were right on point and very concise and helpful, thank you!), and to find out the swelling was normal and could even have been avoided somewhat with proper coaching from my medical team.
I calmed down, put my feet up, slapped a bag of peas on the swelling, and it went down considerably in a matter of less than an hour.
I don't want to irritate the area, but since the only "modeling" my Doctor provided was self-stretching exercises, I'm planning to begin them today. 3 times a day, stretching by holding the head extended forward for 30 seconds. If I get erect I'm to do some moderate counter-bending exercises, too.
Do these exercises appear to be enough? Should I go back and ask him about the wrapping and modeling stuff? My guy has not done a lot of these, so he may not be up on all of that. I suppose that should freak me out to, but he's a very smart, knowledgeable guy and a great a Doc, so maybe the latest guidance is not to do all the wrapping/modeling?
I'll keep posting, as I now know how helpful that can be for the right person in need. The ice pack didn't seem to hurt anything, but now that I know it's just standard swelling I will forego icing unless it gets really bad, just in case.
Cheers,
Greg
Thanks, Timdvm that's very helpful. Unfortunately I work in a business that is not of the adult entertainment variety so I will have to be strategic with my choice of pants.
Greg099-
Did you experience the same- an erection lasting for a few hours post injection?
Quote from: RoyHobbs on June 05, 2014, 03:37:45 PM
In terms of pain and discomfort, do you feel it's possible to return to work after your appointments? For example, if you have a round of injections in the morning can you then head into work?
Depends on the type of job. For a desk job I would say OK, but I wouldn't want to do anything strenuous.
Quote from: Greg099 on June 06, 2014, 06:25:04 AM
First, many thanks to the creators and moderators of this forum. My Doctor didn't do much to prepare me for the potential post injection effects, and I was freaking out last night until I found posts here regarding the swelling that turns out is pretty normal.
Greg
Greg,
Thanks for joining. We can only learn from each other by sharing our experiences.
Hey guys
My doctor recommended I wait 4-5 days after the second injection to start remodeling again. I noticed that quite a few of you are starting remodeling right away --- has anyone had any complications by starting right away? i.e tearing, more bruising etc. and how much pain is there given the amount of swelling and bruising.
I will say this is my second round of injections and the bruising and swelling is half of what it was first time around.
No erection after injection, though I woke with the 'morning wood' at about half mast the day after. I did some mild reverse bend exercise as instructed, but didn't push too hard due to the extreme swelling (not to be dramatic, but twice the normal size is a pretty shocking sight the first time you see it....not in the good way. Lol)
I did the stretching 3 times a day from day 1. No real pain, but the swelling seemed to increase a bit. I had a 2 hour flight on day 2, and found the swelling was still large and bruised looking. I play lead guitar in a band and had a 2 hour concert that night (Friday) probably standing for 4 hours with sound checks and all. I realized that my normal boxer shorts might be exacerbating the problem (gravity and all), so I switched to boxer briefs which held things much better and was pleasantly surprised to find the swelling almost gone the next morning. Today is day 4 and though the entire unit is still a bit larger and tender and a bit bruised looking, it is symmetric and looks mostly normal again.
I think the biggest swelling was some sort of fluid buildup, because it seemd to move around, one day on the side, next day on the bottom. Maybe that is why the tighter boxers helped, as it held things higher allowing the fluid to drain out.
Just guessing, of course. Could be just time passing, but I think it's worth considering.
Didn't do ice again after that first night, as I was relaxed about the swelling and it seems opinion isn't firm on the benefit/risk.
Cheers,
Greg
Greg099
What about straitening? Can see improvement?
James
Day 6, all normal. This morning wood looked like some improvement in the bend. Maybe 5-10 degrees, but definite improvement.
Does Medicare cover Xiaflex ??
I am a patient of Dr Lue and have had several Xiaflex treatments. I've posted elsewhere on this forum regarding some of my experience. If anyone has any questions, feel free to ask. I don't have any issues answering any question in the open forum. I'm happy to share my experiences and help any way I can!
I am seeing great improvement in my condition after 3rd round of injections with xiaflex. Prior to initial treatment I had hourglass deformity and 38degree curve to left. Plaque was hard, and showing signs of calcification. Now, plaque is very soft and smaller. Best news is that hour glassing is gone and curve to left is less than 20 degrees. This is very exciting!. Actually my penis always curved slightly to left. I will probably go another cycle, but already consider this a success. Very happy.
That is excellent news!
I was told they did not allow guys with hour glassing in the trial sessions so it is very refreshing to read progress in that area from at least 2 board members that I know of now.
Hopefully as many of you as possible will continue to keep us updated on your progress and experience as there are many of us hanging in the balance on what to do next.
How about discomfort during and after the injections. How bad is it? Some of the pictures I have seen are horrendous looking.
And what about traction? Is everyone doing Xiaflex injections also doing traction?
Knight
I'm not doing traction, but Dr Lue wants me to start using a vacuum device. It's ordered and on the way! I'll let everyone know how that goes.
As far as the Xiaflex injection, the first time I had a lot of swelling, black and blue (to be expected), and a couple of blisters. He was not happy to see the blisters. I was very sensitive to Xiaflex. The next dose I was given was a third of the normal dose and everything was fine.
Injection stings a bit but not bad. Post injection is variable. So far I have received 6 injections (3 cycles of two injections) an in 2 cases I had swelling and some pain (5 on a scale of 1-10), which was gone in 24 hours. In these two cases penis bruised on entire top surface of shaft, but not on head of penis. Bruise did not hurt and faded from purple to red to pink, and cleared completely in about 1 week. My Doctor said that swelling and bruising is a good sign that drug is working. I have not used traction, just daily modelling for 5 minutes.
In the other 4 injections, little or no visible side effect and no pain. I don't really understand this, but I am happy with results. I hope others have such success.
It is my understanding that the FDA license permitting the use of xiaflex for treatment of peyronies is specific to 15 degrees of curvature or greater. Any coincidental hour-glassing is just that, coincidental to the reason for treatment, which is the 15 degrees of curve. If your presenting condition is only hour-glassing, without over 15 degrees of curve, the doctor treating you may be doing so "off label" for xiaflex. Just my $0.02.
I had my greater than 15 degrees of curvature nearly completely resolved by two Xiaflex injections. A much smaller plaque remains, as does the hour-glassing.
BrooksBro,
Very glad to hear that two shots of Xiaflex resolved your 15 degree curvature (Since I started out at 39 degrees, I'll consider *getting to* 15 degrees a very acceptable end result).
I'm curious about your comment that your hour-glassing remains. Two questions:
1) Does the hour-glassing cause you any erection rigidity or stability issues (ie, hinging)?
2) Did your injects target the locations of the hour-glassing, and they just never resolved? Or were the injection locations not at the site of the hour-glassing?
Thanks!
Mending
One of the problems with the hourglass issue and Xiaflex, is the fact that you can't inject too close to the urethra. The Xiaflex can dissolve a hole in the urethra which is problematic to say the least!
My original bend was 90 degrees down and now it's about 20 degrees...Maybe a little less now. Xiaflex can inadvertently help with the hourglass issue. When the scar tissue dissolves and / or breaks, depending where that strand of scar tissue is running, it can relieve some of the hourglass shape.
Hi everyone
Received a PM from another member about my current status, thought I would post it as it gives my perspective 2 years after the Xiaflex trial, hope it gives some help / hope to others who have this disease.
Here's the text from my original post on the results:
Have just completed my penultimate followup prior to Christmas which involved a measurement, I'll never get used to those injections.
Just to recap from my previous post back in September where I reported the following changes over the course of the trial:
Cycle 1: 8° change, no change in length
Cycle 2: 2° change, no change in length
Cycle 3: 10° change, no change in length
Cycle 4: 0° change, no change in length
This time the Doc measured a further 2° improvement and mentioned that he was seeing ongoing improvement in a number of other patients in the followup period.
The measurement process is not a precise science but hopefully he has enough practice to be consistent.
He also reiterated that he could no longer detect any plaque which he seemed to think was significant.
So overall improvement now at 22° leaving me with a 28° curvature.
One more follow up in 6 weeks so will report the conclusion of my experience after that.
Thanks
S.
The drug didn't fix the curvature totally but my partner reports no difference in sensations or feeling for her, I now need to use viagara to maintain an erection ( I get the cheap stuff online from aumeds.com) but that could be my age as well (57) but I don't think so.
I have had some loss of sensation so takes a lot to achieve orgasm (compared to prior Peyronnies which my partner does not mind - she gets a longer experience). I just have to be a bit careful as the erection is not that strong but adequate to do the job so to speak.
I have lost some length but girth is ok I think.
The doctor did suggest surgery to resolve the bend entirely but I didn't think any benefit would compensate for the loss of further length and it appears to be working quite adequately anyway
Can't tell if there is any further change in the curve over time but it does not impact on our sex life, in fact I would suggest that it has improved a bit from my comments above.
I don't think I would consider another course at this stage, I did ask the question at the time but as he could not locate any further plague at the time there would have been not target for the Xiaflex anyway.
I will probably post my reply to you on the forum, just to give a perspective from someone 2 years down the road so to speak.
Thanks for your interest and the information,hope my observations and experience can't be of some use to you and others in making decisions to use the drug.
Regards
S.
First time posting. I started my Xiaflex injections Monday after a year of a 60degree curvature. Injections were fairly painful. Swelling was out of this world. Penis swollen to about 3x normal size after 12 hours post injections. Swelling went down after 24-36 hours but my Dr decided to wait an extra day to do the second injection set. Originally scheduled for 48 hours after first injections. I waited an extra 24 hours to allow for further reduction in swelling. Second injection more painful but less swelling. I had an early morning erection while asleep on the second day and heard/felt a POP, then strong pain behind the head. It remind sensitive for the rest of the day. Dr thinks that was actually the collagen plaque starting to fracture, which is a great sign.
First modeling session is Monday morning. What should I expect with regards to pain? I'm supposed to drive 3 hrs to a meeting then 3 hours back home. Any thoughts on whether that will be affected by the modeling?
Hey SunnyBob, the same thing happened to me. I was sensitive to the Xiaflex and had a strong reaction as well. The second time around, the amount of Xiaflex was reduced...I'm guessing your doctor also reduced the dosage. I also had scar tissue break. At first I didn't know what it was. Dr Lue did an ultrasound of my penis and it turned out it was just the scar tissue that broke, which he said was a good thing!
Best of luck! Looking forward to some updates!!
Just out of curiosity, if they're using a smaller dosage are they spreading it out over more injections? I mean you're purchasing the entire vial and that vial is incredibly expensive. Where is the remaining xiaflex going?
Thanks Cal. How bad is the modeling? Will I need to rest up after it?
Quote from: RoyHobbs on July 12, 2014, 04:16:47 PM
Just out of curiosity, if they're using a smaller dosage are they spreading it out over more injections? I mean you're purchasing the entire vial and that vial is incredibly expensive. Where is the remaining xiaflex going?
I don't know how they bill my insurance company or what the protocol is for unused product. Does it only come in one vial? If so, maybe they need to produce it in smaller size vials or a glass ampule. I wouldn't want extra injections of this product just because I paid for it...That could be and most likely would be disastrous!
Quote from: SunnyBob on July 12, 2014, 04:32:42 PM
Thanks Cal. How bad is the modeling? Will I need to rest up after it?
I haven't had any issues to speak of.
Several quick updates:
- Modeling/Stretching was today. Extremely painful and caused some more swelling but it didn't last long and the swelling went down in a few hours. Dr pulls the penis straight then bends it vigorously up, down, right and left about the "fulcrum" where the plaque was. (3) sets of 30 seconds each.
- He didn't feel any plaque and said it felt very elastic. That's encouraging since my morning erections have been virtually straight even though I had a 60 degree curve before.
- Now I do the stretches at home for 2 weeks with no intercourse during that time, then return for evaluation.
Insurance has a deal with US BioServices where all costs except Dr co-pay is covered.
SunnyBob
Your improvement is amazing!!!
Strait erection after having 60 degree curve is a huge achievement.
Congratulations
James
All:
I am the second individual in MA to start Xia Flex so I am further along in the process than anyone else in this state except one person. I also have a doctor who is one of the top three most experienced in the country administering of the drug: Dr. Connors, Men's Health Boston (Brookline, MA). He is fantastic. I have tried to chronicle every aspect of treatment from beginning to end because I believe it is important to provide every last detail, leaving nothing to the imagination for those who struggle with this nasty disease. I don't read a lot of the posts.....a few....and from experience I can tell you there is some misinformation being spread. Also, posts tend to be very short....one or two sentences. They leave one with more questions than they answer.
I just had my first shot of round 4 a few hours ago. I asked the doctor not to wrap so tightly this time and he complied so discomfort was minimal afterwards. I decided to work at my desk after the shot (I work from home) and therefore have some swelling from sitting instead of laying on the couch but it is not bad. I am not sure if you can sort posts by screen name but I suggest you do, and read my posts. Most of them are in an other topic under my screen name PMRT.
The doctor says improvement is exponential. Therefore even though I have seen a decent amount of improvement I should see a lot more with this shot. And as I said in my last post a 5th round is possible. Email if you wish at: paulmrt57@gmail.com but read my other posts first. Your question may be answered there.
PMRT
You are very critical about other people posts, so maybe you can elaborate your sentence bellow that we may understand what's wrong:
Quote....some misinformation being spread...
James
My first time here and I am scheduled for two Xiaflex shots next month. Needless to say, reading the posts here I am extremely nervous. The good news is that I see my doctor's name among the posts. I think Dr. Lue is amazing and I can't imagine anyone more knowledgeable. My Peyronies Disease is about a year in. I have an hourglass at the bottom of the shaft and probably a 45 degree at least curve upward. Obviously, loss of length etc. Circumference is okay but it gives me pause to wonder if I can just get buy. The vacuum, Arginine, Ubiquinol haven't seemed to make things any better. The Pentoxifylene has reduced the calcium deposits.
Dr. Lue's practice shows a very good result overall with almost no complications. I guess you just don't want to be the 0.5%. The modeling sounds horrendous. Has anybody been through it all who can offer recommendations, results? I'm not going to look at any pictures. I know we think about causes and Dr. Lue also mentioned that a catheter could be a potential cause (I had a TUNA procedure on my prostate. But who knows. Thanks all. This is a great site.
bromania
From your post I understand you are a male.
So please change your gender from female to male in your profile. :)
James
Hi James:
One example is someone reported that Xia Flex will "eat through the urethra". I asked about that. My doctor said definitely not. My other observation was that many posts are only a sentence or two and, at least for me left me wanting for more information. I found it difficult to gain a picture of what is accurate and what the risks are by piecing together different posts....which is why I don't read a lot of them. It got me anxious and nervous. It seems to me those who have been through the experience.....me or others.....are in the best position to report to those considering Xia Flex what is accurate. I even went into detail about the $700 rebate. Given that my doctor is also amongst the most experienced with the drug I think his responses and advice are also worth listening to.
My 7th shot was yesterday. It has pretty much become routine....as much as something like this can be, I suppose. I am no longer nervous. My doctor is pleased with the results so far and says the scar tissue has softened a great deal (which is why it bends straight more easily). He also says the majority of improvement happens in the last two series of shots (shots 5-8) which is precisely what I am experiencing. Again, I am realistic, having read the actual study results. I am not expecting a perfectly straight shaft although others may get those results. So, sorry about being overly critical. I am just trying to report as accurately and fully as I would want to read from others. Which is why I give an email address if people want to email me.
PMRT
I am appreciating very much your detailed posts.
I don't appreciate your sentences negating/criticizing hundreds of people post, many of them posted they Xiaflex experience during years. We have 50 topics and 1840 posts on the Xiaflex board. Maybe you should read all (as myself and other members has done) and then post your critics.
James
Thanks James. I hope the improvement is retained. I'm still very sore from the modeling yesterday so was only able to do one set of stretches today. For general info, I did not try any of Rx prior to this. My Dr wouldn't prescribe them. He said he had tried them and didn't think they really worked well enough. I did try CoQ10, Vit E, enzymes, VED, stretching and...I think that's it. I only experienced minor improvement from those treatments. I hesitated to share the improvement I've seen so far but it's holding for now, and I pray it continues to.
Definitely better than the clinical studies suggested. My Dr says he is getting mixed results. He's done about five patients and his partner has done about 20 so far.
Quote from: PMRT on July 15, 2014, 09:15:23 AM
Hi James:
One example is someone reported that Xia Flex will "eat through the urethra". I asked about that. My doctor said definitely not.
Hi PMRT,
This I believe, is directed at my comment or to be more direct, Dr Tom Lue's commment to me. If you're unaware of who Dr Lue is, he is also one of the top specialists on Peyronie's disease. First of all, I didn't say Xiaflex WILL eat a hole in the urethra...I said it can put a hole in the urethra IF injected to close to it...Make sure you include the entire sentence! From that point it would need to be repaired with stitches. It is a fact and make sure that when you posed the question to your doctor that it had to do with injecting Xiaflex to close to the urethra. Doctors will not treat scar tissue that is located to close to the urethra with Xiaflex.
I want to take a moment to talk about how Xiaflex came to be. Many of you may know this already. This is a simple explanation but it should make sense on why Xiaflex could put a hole in the urethra. Scientists knew of no compound / drug that could dissolve scar tissue. However, they noticed that when a body decomposed, that scar tissue decomposed as well. From there, they began isolating certain bacteria / enzymes and a long road to Xiaflex was born.
I'm sure many of you have seen the photos where too much Xiaflex has been used and there has been a bad response...Severe swelling, blistering, severe discoloring, etc. PMRT, you said you haven't bothered to look at most of the posts on this site...Here's a link that is on this site...It shows what Xiaflex is capable of if too much is used. The point is, although Xiaflex is helping many people including myself, it's a medication that has the potential to be quite dangerous if misused or used by someone who is not qualified. Here's the link...http://xiaflexpoison.blogspot.com/ (http://xiaflexpoison.blogspot.com/)
The quote deleted by moderator. Please read the forum rules. If you will not comply with the forum rules you will be muted temporarely!!!
Hi bromania,
I am also a patient of Dr Lue and have had several shots of Xiaflex. Feel free to PM me if you have any questions!
are you having results with xiaflex injections?
James:
I already apologized for being overly critical.
CalSF:
I will ask my doctor about it tomorrow but I suspect you are correct. I will read more carefully when I do read. Personally I know the history of Xia Flex and the theory behind its use but it is good for others to read it. To add to your history I also believe it was used successfully for Dupuytren's Contracture before Peyronies Disease, and the medical community saws similarities between the scar tissue in DC and Peyronies Disease. Coincidentally I had (another) doctor with DC and Xia Flex permanently alleviated that condition for him. That was my first exposure to Xia Flex and its possibilities. However there is no question but that Xia Flex is a far more virulent drug than say, Verapamil, and in the hands of someone inexperienced the problems could be many.
You bring up another good point. I don't know how you found your doctor but I found mine through my allergist of all people. I wish I could say it was careful research but it was just plain luck that I found the single most experienced doctor on Xia Flex in MA. My urologist is 45 years in this field but is a total and complete dolt when it comes to Peyronies Disease. He couldn't give me any recommendations at all except to "live with it". I think it behooves anyone considering ANY type of shots in this part of the anatomy to carefully seek out and verify they have a doctor experienced in this drug before proceeding.
Hi PMRT,
It's funny how mentioned it just being luck that you found a top Peyronie's doctor. I was the same way. It just happened to be a matter of geography. I live close to and actually work in San Francisco where Dr Lue practices at UCSF. My first urologist was a big fan of his. You and I are very lucky! This is one of the reasons I try to help everyone here with as much info as I can...I know you're trying to do the same, which is great! I really feel for the members of this forum that don't have access to a urologist who is experienced with Peyronie's and / or Xiaflex. So, anything I can do to help or any question I can answer, I am more than happy to do that!!
Both of you are lucky to find doctor Lue, one of the world leaders Peyronies specialist.
The forum knows him from the very start of the forum, some members even before.
James
CalSF:
I could not agree with you more. This is why I post in such detail. My latest update is below but first a couple of issues:
I asked my doctor about the urethra thing and here is what he said: Ventral (bottom) scars are located below the Urethra but above the tunica albuginea. This area has only one sheath layer whereas dorsal (top) scars have two. Injecting ventral scars runs a higher risk of penis fracture. So, while he is not necessarily disagreeing with your doctor he is saying he doesn't quite see it the same way. I think the summary is there are going to be differences of medical opinion on this just like there is with many medical topics.
For Laddy2266:
My doctor says Dr. Mulhall from Sloan Kettering is the best there is in this field and anyone using him is in excellent hands. He also agrees that unfortunately there is indeed a significant incidence of Peyronies Disease developing after prostate removal, and anyone considering prostate surgery should know about this. He says unfortunately cancer doctors are less interested in sexual function per se (or as much as) a urologist who specializes in reproductive health issues such as a Peyronies Disease. In the best circumstance one considering prostate surgery should have a team of two doctors, each knowledgeable in an area, communicating with each other on the patient's behalf. Yeah, right. We know how likely THAT will be under the new health care law.
My update:
I had my last modeling this morning. Because it was the last one I told him: "Hey doc, knock yourself out" so he went extra hard on the pressure and worked it a couple extra times. The result: I am massively swollen with blood puddled in the skin below the head causing deep purple bruising but I know this is to be expected. And sure, it is sore to the touch but I can function normally otherwise (I would not try jogging, though. :)). I will see him in 4 weeks to assess curvature and the size of the scar. I'm no doctor but frankly I expect both to still exist and therefore am fully prepared to go 5 rounds.....or maybe even more if there is a chance of continued improvement.
To recap: 1st round: Massive bruising/swelling. 2nd round: massive swelling that lasted weeks, not that much bruising. 3rd round: moderate swelling. No bruising. This is the round where I saw the most improvement so far. 4th round this week: little swelling. No bruising. Dr. Connors does not consider this typical, however. It could just as easily be the other way around. I think the point you should take from this is you may or may not have either or both and in any order. It is too soon to see improvement from round 4.
Mr Doctor alternated shot entrance points. First shot of the week on one side and the second shot on the other side, but this week due to a particularly dense scar that is causing a pull to the right he concentrated both shots on that side in that one spot. I think that's about it.
PMRT
Thanks for the update.
I have a question: Who is Laddy2266?
A search for members didn't give me no one.
James
Quick update on my situation. Now a little over a week after my second injection and four days after vigorous modeling. No swelling now but still some bruising. Right behind the head is VERY tender and sensitive. Very difficult to stretch since it's so tender. Best I can tell is I am at about a 10 degree slight upward bend where the major plaque was, then a slight downward bend just beyond that, so net pretty close to back to zero again. Hoping the pain and bruising goes away soon.
I would like to thank PRMT and others here for sharing their experience. I am a candidate for either the shots or graft surgery and I'm somewhat on the fence with it all deciding which procedure to proceed with. Having real life case studies who have currently endured both procedures in real time is invaluable.
Good luck to you all and please keep the info coming!
So ten days after the second injection and six days after the modeling, I achieved a full/solid erection this morning. I have been hesitant to do so till now due to all the warnings in literature and by my Dr about penile fractures. I was able to measure the curvature and at full erection, I'm just under 30 degrees. Not quite the virtually straight I saw at first, but that was when I still had a ton of swelling and penis was not fully erect. Still it's about a 50% improvement over the 60degrees I had prior to the injections. This is the best result shown in the clinical trial literature so I'm pleased with that, and hope it stays that way. It's still very tender and difficult to do the stretches and I hope that improves.
Hi Guys. I've been a member and been reading various threads on this board since December 2013, a few months after I was diagnosed with Peyronies. When diagnosed, I had some plaque and shortening during erection but, very quickly, the plaque got quite large and my erection developed into a full on 60 degree + bend, straight up, very near the base. I'm still amazed at how fast it developed and how stiff the bend is, like an elbow bend in steel pipe! Intercourse was, and is impossible.
I had seen three different Urologists and been through various treatments which were mainly supplements and "wait and see" until I found Dr. Avila in Phoenix. He knows a great deal about the disease and has even done surgery to correct it (showed me some gruesome pictures). Even though Xiaflex had been approved for this, my insurance company didn't have the proper codes, etc. in order to approve it for Peyronies Disease. So, I started on Verapamil and went through, 7 injections of the 16 week, 8 injection course (with some softening of the plaque but no improvement in bend). Then, I got a call I was approved for Xiaflex at only $20 co-pay per injection (Yay, more needles in my penis!).
I just finished my first round of two injections and modeling (I asked for pain block after reading PMRT's posts). After the injections, I had some swelling but lots of bruising, something I never experienced with Verapamil. I thought I would be really sore after the modeling when the numbness wore off but, surprisingly, it wasn't bad. I know Dr. Avila really cranked on it, too. I can already feel a difference in the plaque but will have to wait to see what my erection looks like after the swelling and bruising fade. I'm hoping all the Verapamil injections softened the plaque enough for the Xiaflex to finish the task quickly. Im sick of being poked in the penis! :P Stay tuned...
Cantstopme
I am surprised that after being on the forum some 8 months, you made the Verapamil injection. If you were reading the forum members reports regarding Verapamil you was finding out that the success rate is close to zero.
Any how, wish you success with the Xiaflex.
James
I am now in cycle 4 of xiaflex, and definitely have reduced curvature and as a bonus my erectile disfunction appears to be gone. My question is regarding inconsistency of drug effect. I have now been injected 7 times, but on only 2 occasions did I see the initial swelling and bruising that took about a week to clear. The other 5 times there was no evidence of the side effects. Have others seen a lack of swelling/bruising with some injections? It seems strange to me that my response to the injection should be so variable. Thanks, Pintor
Pintor -
Congratulations on the success of your treatments so far. I've been injected twice, and I've had extremely minimal swelling both times, no bruising once and very minimal bruising the second time.
The following is my theory about a potential cause for the variability of reactions (disclaimer - I'm not a biochemist or a doctor):
If the injection of Xiaflex liquid is deposited entirely within the plaque, you are likely to get almost no bruising and swelling. The collagenase will spend the next few days cleaving collagen in its immediate vicinity until it is no longer clinically potent - having been broken down by proteases. Remember, the plaque is very dense and Xiaflex molecules are relatively large.
But if you receive an injection that is partially outside of the plaque, then the collagen may be more mobile within the surrounding tissue, resulting in wider area of disruption to cell function - and subsequent bruising and swelling.
So I'd say that you received 5 injections that were fully on target, and 2 wherein the drug reached surrounding tissue. I'd say your doctor is doing an excellent job.
Good luck.
Mending the Bend
Dear Mending, i really appreciate your prompt reply. It will be interesting to hear what others have to say. I am very pleased with Xiaflex results so far. Thanks. Pintor
Please share all the names of the most reliable xiaflex
Doctors.
At the moment I only heard about dr gelbard but he'a way too far from europe
I will add my voice to yyy:
QuotePlease share all the names of the most reliable Xiaflex Doctors.
Other members may benefit also from this knowledge.
I opened a topic at:
https://www.peyroniesforum.net/index.php?topic=5357.0
James
Quote from: james1947 on August 20, 2014, 05:44:36 PM
I will add my voice to yyy:
QuotePlease share all the names of the most reliable Xiaflex Doctors.
Other members may benefit also from this knowledge.
I opened a topic at:
https://www.peyroniesforum.net/index.php?topic=5357.0
James
I live in northwest Ohio my Dr. said that he had been through the training and would like to start using the Xiaflex on me but he has never used it yet and I would like to go to a Dr. that has more experience with good results I don't want to be the Dr.'s first. My bend is about 90 degree and I lost three inch's, does anyone know of a experienced Dr. with good results in northern Ohio or lower Michigan that can help me get my life back.
I am now almost 6 weeks out from my 4th and final round (final as far as insurance paying for it is concerned) of Xia-Flex. This last round did not reduce the scar as much as I had hoped but I improved by about another 5 degrees. It did, however, soften the remaining scar much more than past shots. Summary: I am probably at about 35 degrees dorsal curve, down from 65 degrees or more. The pull to the right is reduced as he concentrated on that side last time. Overall the scar is probably down 50-75% in size but is still far larger than I want to live with. Erections are firm and "usable" (funny way to put it, I suppose). Clearly everyone is going to react a bit differently to the medication. I'm guessing (and will ask the next time I see the doctor) that I had a scar on the larger and denser side since I see some have had more dramatic results. For those of you who have not started this you may be thinking the scar melts symmetrically but that is not necessarily the case.
Both Dr. Connors (Men's Health, Boston) and I agree I could likely benefit from continued rounds of Xia Flex. I am paying for it myself now. I found out yesterday the cost to me is $6662.00 for two shots (one week's worth). The drug is apparently discounted slightly when one pays out of pocket. On top of that there is the cost of pain block medication and the doctor's fee. Add 1.5% if you pay by credit card! Hey, this is a business. Anyway, I am perfectly comfortable with this procedure now so I will go for round 5 and even more rounds if the doctor says continued improvement is likely. When there is something more to report I will get back on this forum and do so. You can email me at paulmrt57@gmail.com
Quote from: PMRT on August 27, 2014, 09:34:15 AM
I found out yesterday the cost to me is $6662.00 for two shots (one week's worth). The drug is apparently discounted slightly when one pays out of pocket.
See if you can negotiate with the drug company or pharmacy purchasing the drug to buy it for the negotiated contract price they receive from insurers. I am billed roughly the same amount ($6960) but my insurance plan reduces that to the "eligible amount" of $4525. My insurer pays 75% of this and I pay 25%. So offer them a bit above what they get from insurance, maybe $5k. Still pricey, but less so.
Quote from: Bent Dick on August 24, 2014, 12:00:52 PM
My bend is about 90 degree and I lost three inch's, does anyone know of a experienced Dr. with good results in northern Ohio or lower Michigan that can help me get my life back.
I know it is a bit of a drive, but would highly encourage you to consider Dr. Levine in Chicago.
YYY asked about Doctors. Mine is Dr Gary Price in Arlington Texas. He was involved in the clinical trials for xiaflex and I chose him for that reason. Excellent Doc who has helped me a lot with this condition. I have not yet heard if my insurance will pay for a 5th round of treatment. If not I will not be able to pay for more treatments, but if my condition doesnt worsen I am happy with the improvement as I stated in my previous post. Good luck to all.
To: Mending the bend:
Good point. I tried calling the medication maker but they won't even talk to me. I paid the amount noted in my recent post at my first appointment and had the 5th round last week. I had far less swelling and almost no bruising compared to past rounds but swelling/bruising is irrelevant. It goes away and heals pretty fast. My doctor says to his knowledge I am the first individual to go 5 rounds. It is not a distinction for which I ever anticipated being known (ha). Anyway, for what it's worth during modeling the doctor said he could literally feel bands of scar/plaque "giving way". He was crunching so hard his hands were shaking during the pressure and a bead of sweat came to his brow. He also went an extra round.....4 instead of 3. Thank god for pain block.
I left his office and immediately drove 8 hours to PA. Very mild discomfort if any. I mention this only for those who have never had the treatments and are trying to gage what it is like after having gone this many rounds. I also wish to add for those reading for the first time, my first round of Xia Flex back in March was nasty. Read my earlier posts. In summary, for me it got less eventful each time. I fully expect to go a 6th round and have already set the appointments. I may go a 7th round if the doctor says improvement could continue. The finance people at Men's Health Boston are super so I may ask them to negotiate the drug cost for me. When the swelling goes down to the point where I can more accurately assess improvements I will post again.
does anyone out there know anything about dr Brant in Salt Lake City for Xizflx, his office says they have done hundreds of treatments so far. Any words would be welcome
thatnks
RB3
I don't know Dr. Brant, but you can pass your posts true the speller, we will understand better what you are writing. :)
James
After 2 years I've returned to this site after given up on peyronies treatments I just heard of Xiaflex. Can anyone tell me: 1)can you have sex during the treatment protocol schedule, and 2) how rigid is the schedule? Sometimes work, travel, etc get in the way of EXACT timing. Is it moderately flexible[excuse the pun] for the injections? btw, w/o insurance anybody know how much it costs? rsvp and thank y'all.
foreveryoung
Reading this topic itself and other topics on the Xiaflex board it will give you all the answers and much more.
Just spend some time to read.
James
Foreveryoung,
The maker of Xiaflex, Auxilium Pharmaceuticals, has a program called "Auxilium Advantage". Ask your urologist about it. Its a co-pay assistance program that pays up $1000 (US), per Xiaflex vial, toward your out of pocket costs. They even sent me an official "Copay Assistance Card"! So far, with my insurance coverage and this benefit, I have paid zero out of pocket for the first two series of injections.
foreveryoung . In this country the protocol demands no sex for two weeks after each injection. That is unless your consultant advises more time. Hope that's helpful.
I'm intriqued by the mention of an ultrasound to, I presume, would identify the area, location, and thickness of the plaque, and[I also presume], whether or not it has been calcified. Is this a protocol used by more capable physicians or what????? Should a P.D. patient 'demand'/encourage it?
Quotes from foreveryoung:
QuoteIs this a protocol used by more capable physicians
Yes
QuoteShould a P.D. patient 'demand'/encourage it?
Yes
James
Well I go in tomorrow for my first shot and Thursday for the second. Any advice for prepping tonight or tomorrow to make this a little better experience?
jc961 -
If you've got a good doctor, and he's identified the right location for your shots, then there's nothing else you can do at this point - so try to relax. I've had 4 Xiaflex injections so far, and the procedures themselves aren't a big deal - a little prick ;) and some pressure when the needle goes into the plaque. If you (and the doctor) feel that pressure, then it's a good sign. Do your daily modeling and traction after the 2nd shot and please keep us posted on your results. I hope they're excellent.
Mending the Bend
Thanks Mending! I will definitely keep you guys posted!
Has anyone had an experience with Xiaflex and the Veterans Administration that they'd like to share?
OK guys just had my 2nd shot done this morning. This is my experience from yesterday and today.
Wednesday the 8th 1st shot:
Arrived at 8:40 am for my scheduled apt. The doctor came in and explained the procedure once again to make sure I understood what was to take place. The first thing was to give me an injection to induce an erection, then take measurements and mark the area of bend where the plaque was. After this we would wait until I became flaccid and then do the injection of Xiaflex. No big deal or so I thought (as well as the doctor)! I received the injection around 9:15 am, measurements and markings were done and the DR said I will be back in about 30 minutes to check on you to see if the erection has gone down. 30 minutes later still hard as a rock, so he gave me another 30 minutes. When he came back in still no change. He said he had not even given me a quarter dose to induce the erection and my body must have really taken to the stuff to still have an erection. We decided to wait another 30 minutes....well still no change. At this point I had 3 options...1) Continue to wait it out, 2) Reschedule (another 3 month wait) or 3) He could drain some blood from it. I decided to just go ahead and have him drain it.
He gave me a numbing shot, which was extremely painful and drained about 3 syringes of blood from it. At this point my erection started to fade away. By the time he cleaned up from withdrawing the blood....behold....my erection came back! We decided to try ice packs, which did the trick for the most part after about 30 more minutes. I was still a little stiff but not hard per say so he went ahead and did the Xiaflex shot anyway. He was able to get into the plaque pretty easy. He did warn me that with the numbing shot and blood withdrawal that I would more than likely see some major bruising and tenderness. Boy was he right about that! My penis looks like a thumb that's been smashed with a hammer! Not really painful, just a little discomfort. The swelling right around the area where he took the blood was a little extreme, but an ice pack last night brought that down significantly.
Thursday the 9th 2nd shot:
Arrived at my scheduled time and was taken back immediately. The doctor was not surprised by the swelling and amount of bruising on and around the penis. He felt around and said that he could already tell that the plaque was softening which was a really good sign. So he administered the 2nd shot. This time he said that he could get into the plaque more easily than the day before. I do have to say that this 2nd shot to me was a little more painful than yesterdays shot due to the tenderness and he said he could get more into the plaque because of it being softer.
I have been able to move around good with very little discomfort, only a mild burning sensation where the blood was taken from when it rubs the wrong way. Also just a bit of discomfort when I go to sit down or stand up, other than that not to bad! I start the modeling exercises tomorrow. I had the option to drive back to his office tomorrow to have him do it or do it myself, I chose to do it myself.
That is my experience so far. I will keep you guys posted as to how it turns out. Right now though my penis looks like something off of American Horror Story lol. Wish me luck!
jc961
Wish you luck and excellent results :)
James
@jc961 - There is an injection of some drug that reduces the erection. I had the same choice of waiting out the erection or having the injection of some type of alpha-agonist, and I chose the latter. It was a bit painful, but nowhere near what you described. I also had my 1st Xiaflex that day and had minimal bruising. I would suggest doing some research before your next appointment on what types of injectable drugs are available to eliminate an erection. I go to the Mayo in Rochester, MN and their Urology department may be able to tell you the name of the drug if you run into a dead end. The "blood letting" sounds a little extreme! Yikes!!! My experience with Xiaflex has been pleasant compared to Verapimil (if you've tried that).
Good luck and thanks for your post!
Pointedly
Thanks for the info jc961, good to know. I'll let my dr. know that I'm sensitive to most meds and usually don't need much to get the desired results. Good luck!
hope4all
Tomorrow I start round six (which, at the end of this week will be 12 shots total). For those who have not read my posts four rounds was not enough. I was still experiencing improvement so I decided to go for more rounds at my own expense. I did get the $1000 discount on each of the first four rounds, however. My doctor says choosing four rounds as the protocol by Auxillium and the FDA was somewhat arbitrary anyway and there was no medical reason why more rounds could not be administered. I am his first (and as far as I know) only patient to go more than four rounds although I will ask him this question as well tomorrow.
Now at the end of round five (and it really does take a full 5 weeks for ALL the swelling to go down so you can assess reduction progress) I have again experienced some more size reduction in the plaque, although to me it seems (expensively) minor. That is a bit disappointing. I had hoped for far more "melting". Stubborn little bastard! I probably have a few less degrees of curve (I'd say I am at 35 degrees down from 65 degrees) and the pull to the right has straightened out some more. To that extent it is improving precisely as I predicted: Until it gets down to or below the size it was when I first started experiencing curvature I am still going to have a significant curve. However it is straight enough to manage intercourse but I have to confess during the act I find I am now afraid of damaging it (again??). That doesn't help when it comes to focusing on that which maintains erections, and feeling free to be forceful when the time calls for it. I will ask the doctor about re-damage as well.
To Yoga123: Send me an email. The address is in my profile.
PMRT - I wanted to commend you on your report. I'm headed in for my first injection of Xiaflex next Friday... nervous.. maybe a little but yours & other reports are easing my "is this really happening" feelings.
At 54 my curvature seemed to .. pop up out of nowhere - don't recall any specific 'event' or 'action' that led me down this path. Oh well - I will say I appreciate this forum to read and nod at the similar experiences other guys are having.
I have a 'master-plan' to track-graph and possibly photograph my success .. I'm leaning to the success side of things here ... more for my self and my cheapness in justifying the cost of all this.
Anyhow be well all - I'll be back. 8)
Pointedly - Are you being treated by Dr. Trost? I start the injections on October 30th.
Just a quick update!
It's been exactly 1 week since my second injection. I still have the bend for now, but the plaque has gotten extremely soft compared to what it was! All bruising and soreness except for one little small spot (where he drained blood to reduce my erection) has gone away as well!
I do have a question? I've heard people say they felt or heard a pop in their penis when the plaque finally starts breaking apart...what is the time line for this? Couple of weeks after the shots or longer? Will keep everyone posted on the progress (or lack thereof)!
jc961 -
Not everyone hears or feels a pop or cracking sound; I never did. It's great to feel the plaque softening, though. Are you doing traction now? You should be doing it every day, try for at least an hour or two. The bend should improve as the traction lengthens the plaque which has been weakened by the Xiaflex. That's why it's essential to use traction for the entire 6-week interval between rounds. Hopefully you will experience gradual improvement over the next several weeks.
Good luck.
No traction at this time. Are you referring to a device? My doctor said he has seen good results with and without traction.
OK, now confused. What is 'traction'? is it 'modeling'?/manual 'stretching'? what?
These are devices you wear that apply traction along the length or your penis. We have a board dedicated to this topic.
https://www.peyroniesforum.net/index.php/board,35.0.html (https://www.peyroniesforum.net/index.php/board,35.0.html)
jc961 -
My humble advice is that you should be doing:
1) Modeling - manual stretching of the penis for ~30 seconds, several times, potentially using the plaque as a fulcrum to bend your stretched penis in the opposite direction of your curve.
2) Traction - with a traction device (I use an inexpensive one from X4 labs, seems to be almost identical to many other brands), for at least 30 mins per day, and preferably up to 2 hours.
The Xiaflex study showed that those who did traction/modeling had a greater degree of improvement.
@mending
Do you use the Peyronies Edition or the Premium Edition?
It's Thursday night, the day of my second shot of round six. Similar swelling as last few times. No discoloration. Minor discomfort but I am not handling it much either. I am performing stretching as directed from day one. I do not use traction. Tomorrow is modeling. The first several rounds included three, 30 second forceful breakups. In the last couple of rounds the doctor went four, 30 second rounds. The doctor agreed with me; we both had expected a bit more size reduction from round five than I got so tomorrow we agreed on six or more 30 second rounds of modeling. I suggested (and the doctor agreed) to have me back early next week and again late next week for additional modeling. This is new. It has never been tried before by any doctor to his knowledge. Charting new territory so-to-speak. I asked about self modeling. He says it is ok but he doubts one can give it the force the doctor can give. I tend to agree with that but perhaps there are plenty of you out there with high pain tolerance.
Some questions I asked and answers:
1. Now that he has 50-100 patients in treatment is anyone doing more than 4 rounds? Answer: he has one about to go for round 5.
2. How are his improvement stats as compared to the national average in the study? Answer: better than the study averages so far.
3. Any patient with any bad outcomes? Answer: No, none.
4. Does he know the reason for some of the disaster pictures (I never looked at them). Answer: No, but he feels if there is going to be a negative response it would probably be with round 1. He has never heard of disasters occurring with subsequent rounds if earlier rounds were fine. For those super-concerned about this, perhaps you should ask for a very small dose for the first round. Just a thought by me. Of course it uses up one of your rounds in terms of insurance, I suppose.
5. Would additional modeling be a benefit. He had never thought of that but yes, he does believe it could help with plaque breakup especially soon after shots while the medicine is still active. Hence my extra rounds of modeling next week.
6. I told him about my concerns of re-damage during intercourse. Answer: Agreed, one wants to be careful. Woman on top is off limits in his view (my favorite, too bad). Best is from behind. Missionary is ok. From the side is preferred.
7. Even without Peyronies Disease I don't have the strong erections I had as a younger man and now with worrying about damage maintaining hardness is an issue. Solution: He offered two ED meds. Stendra (no name brand but just as effective and doesn't have the "empty stomach" requirement, and Levitra. Both preferred over Viagra in his view.
Going forward: Modeling tomorrow, next Tuesday and again a week from tomorrow. Reassessment in 5 weeks. At that time we decide if I am still progressing and we go for round 7. Hey, it's only money. OK, so sex isn't what it used to be but just the fact that I can penetrate and have closeness with my wife again makes me feel like a million bucks. Good return on investment if you ask me. I am back in the gym. I can concentrate on work and family and enjoy life again. I sincerely wish the same for all of you. It is why I write in such detail.
Without having to read through all the forums again...how long before you guys started seeing any straightening of your bend? I know it's different for everyone, just trying to get an estimate.
Thanks
jc961 -
My lateral curve reduced by about 12 degrees (from 39 to 27) within one week after my first injection. It was a very noticeable change. Subsequent reductions have been somewhat more gradual, but steady.
In November the lead docs from around the world are coming together to talk about there findings and how best to use the drug as in best ways to inject etc etc, My Doc is attending hence i am holding off from having it in case he learns better ways of using it. Some people beleive its best used with traction etc
dob32,
"...coming together..." WHERE? WHEN? WHOSE forum? details por favor?
foreveryoung
I have completed my 4th round of xiaflex and seen improvement in the bend and wasting, but the remaining plaque still prevents full rigidity in the tip or distal penis (which about 1/3 the distal length of my penis) So I still get buckling or hinging at the site of the plaque. Has anyone else had this problem and has it improved with xiaflex. I am considering paying out of pocket for a 5th round but would like to know if anyone else has had it work for this type of problem.
And what is the cost out of pocket for those of you that are going beyond 4 rounds of xiflex injections?
Timdvm -
I will be starting round 4 next month, and I have similar concerns about still having buckling issues at the end of it. My curvature has improved dramatically, but hourglassing is still present (though diminished). I am hoping that these last two shots break up enough plaque to restore more rigidity.
Paying out of pocket will cost about $6k per round for the drug, plus doctor and facility costs. A steep bill, and I would also only pay if it promised a reasonable chance of success. The problem is that the doctors don't exactly know how best to use Xiaflex for hourglassing. It is easier to measure curve improvements, which is what they did in clinical trials.
How much improvement did you see from beginning to end in curvature? And have you been doing regular traction, VED, modeling?
Quote from: foreveryoung on October 21, 2014, 08:24:48 PM
dob32,
"...coming together..." WHERE? WHEN? WHOSE forum? details por favor?
foreveryoung
It is in the USA and this month sometime, no idea on details as i dont see him again until feb, as i have to wait for my condition to settle. After looking at my condition pretty much said could get it near hundred percent with a few stitches and our health system will cover that. But the shots are not covered and 1200 a pop. So cost about 8k for the lot. Can only guarantee about 70% better with the shots tho. So he said hopefully after the meeting will be better at using the shots etc, as may be able to fix hour glass with it etc if used in certain ways
Hey Mending the Bend,
I have seen a lot of improvement in the curvature when standing up. But when laying down the buckling or hinging allows it to flop back to a 90degree bend just by the weight of the glans. My hourglassing has improved as well. I only have a single section of plaque dorsally remaining and I am hoping one more injection will have huge impact but can't pay 6,000.
I am doing stretching a few times a day even though I am past the 6 weeks mark from the last injection. I use the plaque as a fulcrum. When erect I try to do the straightening. What other remodeling have you done?
I'm a newbie in this forum. 67 y/o male with a 90 degree curvature for 14 months. I have had two rounds of Xiaflex (4 injections) with absolutely no improvement whatsoever. I have asked Auxilium Pharmaceuticals if in their trials they had any success on round number three with two previous failures but they will not return my calls as they promised. Has anyone out there had any success on round three with no improvement in the first two? Thanks.
Hi Gyneguy!
You are not the only one! I participated in the phase3 trial. I started with 70 degree curvature. After 8 injection doc could measure ~60 degree curvature. More or less NO improvement :( Xiaflex is nothing but a fraud and only a moneymaker for Auxilium. It´s a mystery that FDA could approve this snake-oil. The answer is probably MONEY TALKS even in FDA - they are corrupt! You will never get any return calls from Auxilium !
[Full quote removed by Admin]
Hey guys.
I thought I would respond to the conversation. Be sure to discuss expectations with your doctor. Xiaflex is not a cure all. I have had 8 injections and seen quite a bit of improvement. But Keep in mind that your results are very much affected by the skill of your doctor in getting the medicine in the right location. The plaque itself has also damaged the elastic fibers in the tunica and xiaflex will not repair it. It only disolves specific types of scar tissue bands and will not repair the other tissues that have been damaged by the Peyronies
Many people even in the trial saw no results - but enough men had enough change to warrant its approval. I myself had a large part of the hard plaque dissolve - the tissue is now again soft, but the elastin was damaged by the disease I did not get that back so I still have a bend and loss of rigidity - but I am much better off than before the xiaflex- that's for sure.
Quote from: ThisWontWork on November 16, 2014, 05:35:11 PM
Xiaflex is nothing but a fraud and only a moneymaker for Auxilium. It´s a mystery that FDA could approve this snake-oil. The answer is probably MONEY TALKS even in FDA - they are corrupt! You will never get any return calls from Auxilium !
You are certainly entitled to your opinion, but I think calling them corrupt might be a bit strong. There was never any promise that this drug would cure everyone. There was a lot of pre-release hype that this was the new miracle drug. And clearly there are some members here who have seen improvement from the use of Xiaflex.
Hi all,
I joined the forum recently and this is my first post, so I hope I am writing on the right spot altogether...
First of all, just congratulate and thank all the members posting their experiences. When you are diagnosed with Peyronies Disease it is quite difficult to cope with many unknowns: Why? How? Will I ever? What to do? Is this the best solution? You know what I mean. For me, this forum has given me a lot of information as well as comfort, hope, advice... So, yeah! Thanks a lot really!
In my case, I am actually lucky enough to have run to one of the best experts in this field in my country, Spain. My urologist, Dr. Martínez-Salamanca is quite reputed in Peyronies Disease and since day one gave me a clear diagnosis, expectancies and treatment right away. He is a quite energetic and positive guy and was honest to clearly lay out the "contained" (so to speak) prospects of oral treatment (which I appreciated), but was also super clear in giving me hopes with combining it with PTT with constancy and patience! He prescribed Tadalafil 2,5 mg/day and Pentoxyfilline 400 mg bid. He also recommended daily massages with Argan Oil to stretch the penis trough a soft massage; at least it would not hurt.
He explained to me some of the latest insights in the results of studies he himself and other colleagues had conducted and are conducting and the ideas they are sharing with American colleagues when they meet in medical summits (Dr. Gelbard, Dr. Lue, Dr. Levine...). Reading that all these leading doctors were treating some of you, made me feel that at least I was trying my best and was in the right hands. Sometimes, I believe you will all agree, it is not easy to cope with suddenly having this condition out of the blue... (In my case I cannot get any explanation why...)
(I hope this introduction was not too long and off-putting) But I thought it was important to come to the topic: My Xiaflex experience
Right on my first visit (I had done my homework in internet on this forum) my Dr. told me that apart from oral treatment + PTT (of which there were proven results of their efficacy) and surgery there was nothing else that could be done, except a new drug that was under clinical trial at that moment: Xiaflex. He informed me that it was not yet approved and unfortunately not available in Spain. However, he was trying to bring it.
Shortly after, the drug was finally FDA approved for its use with Peyronies Disease in the US. In the case of Europe, Xiaflex is called Xiapex and is readily available for its use for DC. Thankfully, this summer he told me that wanted to try Xiapex (I believe it can be used as a compassionate method and therefore no insurance will cover it as it is not yet filed with the European Medicine Agency as Peyronies Disease treatment) and he was going to do it with some of his patients.
I told him, after some light thought, that I wanted to try it as well, so we scheduled a date in October 2014.
To tell you a bit about my actual diagnosis and evolution data:
Since September 2013, that I perceived one first small lump, until I got the first appointment with my doctor (February 2014) I had developed a 30º upward curve highly hinged (somewhat like the penis was broken into 2 halves) and with pain when erect.
After my first visit in Feb 2014 I got a Doppler and 4 heavily calcified plaques were identified scattered around the penis in random places (how they got there, can somebody tell me?).
During the next 9 months even with the treatment (oral+PTT) I developed to a 55º-60º curve with a main hourglass and narrowing about 4 cm below the glans and another smaller hour-glassing in the same spot where I noticed that first lump. The pain had somewhat reduced but with the narrowing came an intense feeling of oppression in the area. The soft hinging had receded and now I had a hard upward-curved erection with a large lateral disfiguration (quite local indentation) and overall moderate narrowing from the point of curvature until the glans.
XIAFLEX shot treatment (October 15th 2014):
My treatment was somewhat different to the ones you all describe. I received 1 only shot of Xiapex in the location of plaque causing the curvature.
My Dr. also planned to have a different modelling technique, by injecting saline solution causing an erection to "play" with the plaque at an erect state 1-2 days after the shot.
The day of the shot I was both anxious, excited (and completely terrified to be honest...) He gave me the shot after giving me some local anesthesia and, truth be told, it was painful but somewhat manageable. He applied pressure and bandaged the penis. Told me to remove it after 2-3 hours.
After the shot, and when the anesthesia went off, I could feel intense heat and a tingling sensation, painful at times, but nothing too extreme. My penis swallowed immediately after I removed the bandage and became increasingly blueish. The next day, the swallowing was max and the color reached a nice dark purple but not too much pain except to touch (then it would hurt a lot...)
The next day I went for modelling, but as I had considerate swelling (nothing like double-sized but very noticeable) my Dr. told me to wait a couple of additional days for the modelling.
The swallowing was soon almost gone (4 days after the shot) and only the very dark superficial bruising was present when I finally went in for modelling. Unfortunately when Dr. Martínez-Salamanca tried to inject me the saline solution, I experienced agonizing pain. Perhaps it is my low tolerance to pain or it is that I was too tender, but we could not finally do it. So he told me to go home and to do the usual modelling (stretching) once the pain from the failed procedure had subsided.
So I did and repeated it every day for 2 weeks. Also he told me to bend the penis straight when erect for a while to stretch the plaque. I did this too once a day.
I was scared of having a full erection, but finally after 12-15 days I could get a full one. I measured myself, took pictures and performed a thorough comparison with the pictures over the computer. The result? 30º to 35º angle. I had lost 25º approx. with 1 shot! The hourglassing had also improved, in the sense that the deepest area of indentation was now flatter. However I still have an indentation and narrowing in both sides from the base of the glans to the origin of the plaque but the improvement can be definitely seen.
I cannot say enough how ecstatic I was! It is not perfect of course, but only with one shot I had reduced the curvature about 40%. I had read enough and was under the impression I was the non-ideal candidate: calcified plaques (maybe the calcification has improved thanks to the pentox this last 7 months... I have no way to know) and hourglassing... but the results are in my opinion fantastic.
As a note: Dr. Martínez-Salamanca told me that they were expecting 2 possibilities as per the experience with Xiapex in DC in Spain. If the first shot yielded no results at all, probably there would not be much gain in successive injections.
Now, with these results I am planning to have at least 1 more shot and hopefully have Xiapex approved for its therapeutic use in Peyronies Disease in Europe with all the perks and benefits of insurance coverage. It is definitely not cheap!!
Now I am continuing with the PTT and the oral treatment (I will keep you posted as, by the time I am writing this post I am getting the feeling I am improving further in the curvature...)
For the next shot I will ask my doctor if he can perform the modelling himself straight away, as I read in one of the earlier posts that Dr. Gelbard was advocating for modelling right away based on his experience...
In summary, I do not wish to impart any type of false hope or excessive optimism. I still have about 35º, narrowing, and so on... And perhaps I am one of the lucky ones with Xiaflex, but, honestly: before, I was just seeing my penis bending month after month (I believe the treatment was most certainly slowing the process, but nature was taking its due course, that's for sure...). At least now I know there is something that is giving me hope.
In my case it was that feeling of inevitability that killed me... Not knowing when it will stop the acute phase, the problems to have sex... you all know. At least I think there is now one more thing to fight this condition and for the posts I read I am not the only one satisfied...
I hope all of you get better. Please feel free to contact me and ask me any questions as maybe my post is too long, badly structured and perhaps left some important info out...
Thanks again for the forum!
Any improvement in length? You Also have a PRivate message
Good post Nick77! Thanks for sharing your experience and hope! Good luck with round 2!
Thanks for the post Nick.
It will help others in Europe, as the information is very limited.
What about the payment?
James
Anyone not had any change after the first shots...but did have positive changes with the second series or third?
jc961
You should spend some time reading this board and you will find the answers
James
@james1947 I have read the boards in the past...but I don't have time (as I'm sure most people don't) to go back through every post every time I have a question! It's a lot easier and quicker to ask and receive an answer. I have the second round coming up in the AM and was asking to see what my expectations should be.
I am in the same boat. I don't think I have had any benefit after round 1 and also have round 2 coming up in a couple weeks. I think your question is excellent and I don't recall if there have been any similar accountings from guys who have gone through it. It seems to me that most have had thier most dramatic improvements after round 1, but I dont remember anyone saying they didn't get any results until the 2nd or 3rd round.
Good luck!
I hope this round is very successful for you!
jc961
You don't have time, but expecting others to find time. Nice.
James
@Knight Thank you for your feedback! I start round 2 Tomorrow so I will keep everyone posted!
@james1947
I would expect the answers from a moderator of this sight to be a little NICER! If no one answers me, then so be it! But I don't need the negative vibes that you are showing. It's bad enough we all have to deal with this horrible disease! I thought this site was to HELP each other. Please let me know if I was mistaken!
Quote from: jc961 on December 03, 2014, 09:35:34 AM
Anyone not had any change after the first shots...but did have positive changes with the second series or third?
I'll take a stab (pun intended) at this one. Before my Xiaflex shots, I had bilateral curvature - roughly 40 degrees lateral and 40 dorsal. I experienced a big improvement in lateral curve immediately, but my dorsal curve didn't see any reduction in curve until the 3rd or 4th shot. Granted, we were targeting the lateral aspect of the curve initially, and I was pretty happy with those results. But nonetheless, I had no observable improvement in upward curve after a few shots. Since then, though, it has been reduced by about 50%. Hang in there, and keep up with the modeling and traction. Those are important.
Quote from: james1947 on December 03, 2014, 09:08:35 PM
jc961
You don't have time, but expecting others to find time. Nice.
James
james good manners costs nothing. people enter this very complicated forum (olive oil, prp,saw palmetto .... nice!) for support not to be put down.
Hey Guys. Anyone had more than the 4 xiaflex series? I completed the series and still have a palpable plaque. I initially had a large plaque along the top, wasting at the plaque and lack of rigidly after the plaque area. I saw some improvement with the xiaflex but wondering if the expense is worth going past the 4 rounds - any thoughts would be apprediated.
You may want to Private Message PMRT, or read his posts. I think he's had 6 rounds of shots, maybe more.
Hello everyone, I just want to let you know that I am going ahead with Xiaflex with my first round of injections tomorrow and Thursday. My doctor is Dr. Metro in Norristown PA. He was part of the trials and when I saw him about 6-8 months ago, he was presenting to a group of urologists the following day. He told me then that he wants his patients to use traction with the other modeling procedures recommended with the Xiaflex treatments.
It seems that since then, others on this site have also been told to use traction. I plan on bringing my traction device and using it immediately after each injection. He told me that the best results he has seen were with patients that did traction 2-3 hours per day with the Xiaflex. Those that did not, got less results.
I use the Vac3 extender and I bought a "peyronies" modification that stretches the penis over a bar in the traction device, further stretching the plaque for someone with an upward curve.
My official measurement is a 40 degree upward curve with some distal narrowing.
I will keep everyone posted.
Best of luck IhatePD! Keep us posted on your recovery and early results. I've probably seen a 10 degree improvement from my first round of shots, from a 50-60 degree upward curve and some of my girth has returned on the left side.
I'm going for my 2nd round at the end of Feb. Good luck again!
hope4all
Update:
I had my first round of shots over the last two days. After the first shot, I did traction that night for two hours without any pain or swelling.
After the second shot, I asked my doctor why he wants me to wait till Saturday to do the traction and modeling and he said that during the first day or so there is an increased risk of rupture. I wanted to do the traction after the second shot but decided to hold off. I will probably do some tonight. I don't feel sore at all and very little initial swelling. The doctor gave me an ice pack to wear after each shot and it seemed to work.
The second shot hurt more than the first. The angle was different, he injected me in a plaque/chord starting from the glands and injected towards my torso. The first shot was latterally in the same area but from my right side across my penis. The second shot seemed to take longer as well.
I will do at least 2-4 hours per day of traction starting with two hours tonight. I will be very careful as I would rather need another round of shots verses a ruptured penis.
So far, no brusing and no pain. I am very surprised about the no brusing as I tend to easily. I had an erection last night and it seemed to be about the the same bend. I did not do modeling per my doctors instructions.
Question to those who have experienced positive results with Xiaflex: how long was is before you started to see results?
@IhatePD:
I didn't notice any significant improvement in curvature until injection #6. Here is what I did for modeling:
Injections 1 & 2 - Standard pulling for 30 seconds with straight pull, immediately followed by straight pull & down bend, 6-7x/day. Dr. Trost also recommended traction, but I didn't do it until 3-4 days post injection.
Injections 3 & 4 - Tried "premodeling" for each injection by wearing traction for the 1 hour drive to Mayo Clinic. Wore traction on the way home both days & did it again each night for an hour or so. Also continued with hand modeling as described above.
Injections 5 & 6 - Traction on the way home each day. On the way home after #6, I felt a slightly sharp pain after a half hour of traction and felt something "let go". It felt like the device had slipped off, but I looked down and it was still in place - I think it was the plaque breaking up. My first erection after the swelling disappeared, I noticed that I was probably 45 degrees vs. the 69 I started with.
To answer your question in your last sentence, I saw very slight (emphasis VERY SLIGHT) improvement in curve after 3 & 4, but the pain I was experiencing with any erection, diminished after 1 & 2.
Injections 7 & 8 - Today is Sunday, # 7 was Thursday and #8 was Friday (2 days ago). I swelled very badly on Thursday after traction on the way home. I wrapped the unit in gauze that night so the injection could be done the next morning. Friday traction was EXTREMELY DIFFICULT because the device kept slipping off due to the previous swelling. It was disappointing because I was hoping something would "let go" on the way home,, like after #6.
I never try to gauge results until a week or so, post injection. I think the swelling at the injection site probably expands the plaque and makes the bend less severe. Do what you are comfortable with as far as traction. What you and I and everyone else getting Xiaflex injections amounts to nothing more than an "extended clinical trial." I waited until some of the early patients got injected after FDA approval. I knew that by the time I got my first injection, that Dr. Trost could tell me what his patients with the best results were doing for modeling.
Does your doctor give you that same info? What the patients with the best results have done for modeling? AT A VERY MINIMUM, I would do the hand modeling after each injection. The drug is most active for 1-2 hours, post injection. It's a golden moment to have plaque be broken up. Dr. Trost has also indicated that the 24-48 hours after the injections are critical for modeling.
One thing I always do is use hot packs prior to traction (except immediately post injection) since I think it warms up the muscle before making it "work".
Hang in there. You will see some results. Be smart, but aggressive with the modeling. I would not try anything new, immediately post injection. I think it's a mistake to add tension or try a new length with a traction device, immediately post injection. I, emphasis I, am comfortable applying the same length of traction that I have worked up to for a week prior to the day of injection.
Talk to your doctor before the next round about modeling's relationship to results with his other patients. If he seems unsure, ask him if he would consider talking to Dr. Trost or his assistant Josh at Mayo - Rochester about their opinions. We are not operating in a vacuum here - this is a forum for sharing experiences, ideas, etc.., about a disease that is difficult to treat and overcome.
Doctors are the same way (or should be) and I KNOW that Trost would be eager to share ideas and info with his colleagues.
pointedly,
Thanks for the info. My doctor said that his patients that did traction experienced the best results, 2-3 hours per day. I am doing at least 6 hours per day starting last Saturday, 48 hours after my 2nd injection. I am getting up very early to get 2-4 hours in before I leave the house and then finishing at night. The Vac3 extender helps a lot. I couldn't use a strap traction device for that long a time.
I am not really seeing any change in my upward bend but my distal narrowing has improved a little, enough so that my girlfriend saw it first. I know I was supposed to wait 2 weeks before sex but I couldn't wait and had sex Saturday, 9 days after my 2nd injection. I was VERY CAREFUL and never inserted my penis all the way, just played in and out with a few inches only. No pain and no damage. My girlfriend has our 2 week mark ready to go. I told her we still need to take it easy as this is all new and I don't know what might happen.
My doctor felt I should wait until 48 hours passed before using traction as it increases the risk of rupture. I really want to use it right away and might do so on my next round. I agree that the traction length right after the shots should be the same as you used leading up to the injections and not be increased. I use a relatively strong amount of traction and I get sore where the base of the traction device presses on the skin at the top of my scrotum.
I will keep up with the traction and will start adding the VED as well. I will keep everyone posted on my progress.
Guys an important question
I had just one xiaflex injection in December.
I can't understand how you can wear an extender the same days. In my case, once the anesthesia was gone, I started to feel some terrible pain and I could not use the extender until day 4th.
So when exactly are you using the extender? Immediately after or some hours after?
Don't you risk a penile fracture by using a device so soon?
Thanks
Not an answer to your question yyy, but when and where you got the injection?
I know you was searching for a doctor back in November 2014.
What are the results?
Why you got just one injection?
Please let us know.
Not connected to the subject, thank you for proposing me the Avanafil back in October. :) I miss your post.
James
Guys it's important, please reply
James I had one injection which helped me a little for rigidity but not for the bend
Hello,
I am very sad to report that I am one of the victims of the xiaflex causing a corporal puncture and penile fracture. I am crying as I am writing this. On 3/31/15 dr Conners at mens health in boston did the modeling after 3rd round. He killed me and on the way home my penis erupted. Blood everywhere. Conners completely dismissed my complaints of pain during rounds2 and 3. He said its normal and to grin and bear it. His modeling was so vigorous and strong that he broke my penis.
I was in hospital for 2 days. Now I have gone to a reconstructive specialist.
He says I for sure have hole internally. Conners still refuses to admit it. Now since Conners missed it, can not do surgery to fix it. Must wait. Too risky for surgery today. Too much bleeding.
Now my new specialist has ordered me off my feet so bleeding does not get worse.
I am lost and hurt. My poor wife is so supportive, but it's taking its toll.
Worse than a nightmare...
kdb123
I am with you from all my hearth and wish you passing this bad time as soon as you can.
I always said that in my opinion the success of Xiaflex depends on the doctor capability, same as the horror stories we have on the forum.
I updated the doctors list with your report on Dr. Conners, at least other members will not do the Xiaflex with him.
Wish you recover soon and the new specialist will find a way to help you
James
Thank you James.
kdb123, I am heartbroken for you. There are no words, I'm glad your wife is there to comfort you. Thank you for sharing your experience. I just wrote a post on another thread that said we are all basically still in the trial phase even though it is approved.
I know you are suffering right now, but when you begin to heal, will you consider contacting Auxilium or US Bioservices? The FDA? The more people that share their experiences, good or bad, with the FDA may help change the treatment.
Let us know how you are progressing.
hope4all
Thanks hope,
The situation gets crazier. Conners and his partner kecker are confident i do not have a fracture or puncture. Dr vanni a reconstruction specialist says he is pretty confident at this point that i do.
I am stuck in the middle.
I am actually thinking of finding another uro as well.
For now, vanni says total rest and kecker wants to compression wrap to make me a little more mobile.
Trying to take it one day at a time....
K
I have also reported to fda. Will also report to auxillium.
Dreadful news kdb123.
All best wishes from the UK.
kdb123 I am so sorry to hear what happened to you. Please keep us posted on your progress. Iam hoping for the best for you.
I went for my second round of Xiaflex injections last week. My doctor - Dr. Metro in Norristown PA does not do the modeling. He told me that after each round of injections on a Wednesday and Thursday not to model or do traction until 48 hrs. later on Saturday. On my second round last week, I decided to do the traction - 4 hours each day starting with the first injection. Nothing too crazy just enough to keep it stretched. I did not do the modeling when erect. That gets me nervous. I got a little bruising this time around from the immediate traction but I think it is breaking up the plaque at a faster rate because of it. I also had sex last Saturday - 9 days later instead of waiting 2 weeks.
I realize that it is not smart going against the doctors instructions but I do not feel that I am hurting myself with the traction and quite frankly I just couldn't wait on the sex part. What happened to kdb123 will make me a little more cautious on the next two rounds.
So far, I am getting noticeably fuller where I had distal narrowing but not much reduction on the curve. My girlfriend says that I feel thicker and still wants me to keep the curve as it "hits places no one has ever hit before." I still want it straight, it freaks me out when I see it bent and having her on top or from behind require great care. I will take an erect picture before the next round and have the doctor give me the degrees remaining in the bend. My starting point was 40 degrees.
I also had an incredible pain during the injection which seems not normal to me. Maybe he did inject into the corpora, I don't think I will continue for the moment
Hi, kdb123. Man, sounds like a lot of CYA going on up there in Boston from your providers.
Thank you for reporting your experiences to the FDA and Auxilium! I will be doing the same once I'm done with the treatment.
IhatePD, it sounds like you and I are in the same boat when it comes to "going off label" with this treatment...within reason of course. I've done (light) traction immediately following my injections. I started that in my 2nd cycle of shots and continued with this 3rd cycle i'm currently in. After my 5th shot Wednesday morning I immediately noticed a hematoma which meant to me I was going to see some serious swelling and bruising pretty quickly. Sure enough, within hours it started, to the point that my doctor decided to delay the 2nd shot until next week after seeing the redness/bruising/swelling when I went today for the 2nd shot in this cycle.
My doctor doesn't do the modeling just like yours doesn't IhatePD, so the mild traction is a replacement for that. It's probably increased the bruising for me, but I'm fine with that FOR ME. I do not promote this for anyone else, it just feels right for me. My plaque is 6 years old and isn't getting any softer so my approach is to straighten it when it's softest. I'm very careful when I get nighttime erections not to go too far in the straightening exercises, for fear of rupture.
The way the in-office modeling is described in the REMS I would imagine it would cause serious discomfort while performing it and serious bruising afterwards. I can't imagine having someone model my penis in its current state without a sedative of some sort.
Hello all,
Here is an update that is quite graphic in one part. Do not read on if you are not prepared for a very difficult image:
So the major difference between dr Conners and dr Kacker at mens health boston and the penile reconstruction specialist dr vanni at lahey clinic is the following:
'WARNING'
When I had the horrific incident on 3/31 when my penis basically erupted after the 3rd round of modeling, when I was in emergency room dr Conners came into examine me. Conners claims that while my wound was open he could feel and see inside and is very confident there is no rupture or of corpora or tunica. He stuck his finger inside to feel around. Dr. Vanni does not think this is the case. He thinks i do have a fracture/rupture/hole or whatever you call it.
Since I do have some erection action which I try to keep down at least now, Conners and Kacker thinks this is further good evidence that there is no fracture.
Conners gave me the name of vannis partner to go see at Lahey. He is dr Bennett. He does the xiaflex shots for lahey. Conners would like me to see him because he is familiar with xiaflex and vanni does not do the shots. I hope to get an appt w him ASAP.
Also Conners gave me another Uro, dr munarriz at boston medical center to go see.
Obviously still need rest and a lot of time. Still on roller coaster but these guys were confident. Let's see why the two new guys say
Great news for me today. MRI showed no holes or penile fracture. Now both uros agree!
At least surgery is off the table.
Now a long healing process which will keep me off my feet for awhile and then really taking it slowly.
All in all, I am feeling very lucky today. Thanks for listening.
K
Good news kdb :)
As we always are saying, the diagnosis MUST include an ultrasound, definitely MRI can show even more.
James
kdb, I'm relieved to hear this, it's great news! Once you're healed from this setback perhaps you should pass on the in-office modeling. :) I wish you a very speedy recovery so you can get back on track! Take care.
hope
Moderated your post (James) as you have posted exactly the same post on:
FORUM XIAFLEX RESULTS - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,6273.0.html)
Double post is not allowed on the forum.
Summary: Procedure was reasonably free of pain;
penis looked like roasted hot dog for a week and the reaction to the injections is 95% better after 3 weeks. However, the curve did not budge. My diagnostic ultrasound showed substantial plaque within cavernosa as well as in the tunica.
Neverheardofthisb4
This is the only session Dr. Lue is planning?
Usual treatment is 4 sessions.
James
Neverheardofthisb4, quite a few of our guys on the trial in the UK got negligible improvement or no change at all after round 1. All our doctors, and I have seen it on this forum too, say the best results come after cycle 3 and/or later.
Hello All,
Have had Peyronies Disease for about a year. Went to a local Doc who told me to take Vitamin E and maybe it would go away.
Decided to seek another doc and now I am getting ready for my first xiaflex shot next week. Have been reading everyone's entries and I must say I am a little nervous.
Planning on sharing my results here and what the doc has to say.
trouble with the curve
Wish you good results :)
Don't forget to update your results at:
FORUM XIAFLEX RESULTS - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,6273.0.html)
James
Hi Guys,
Finished 1st shot yesterday. Will post results over on results topic.
Everything seems to be moving very fast from 1st DR. visit when I heard of xiaflex. Less than a month and I am having treatment. Thought I read here earlier of a doc in Burbank Ca. USA who had a great deal of experience with the treatments.
Could someone provide his name?
Thanks much,
Trouble
Hey trouble wtc, I've seen Dr Gelbard's name on these boards several times. He's in Burbank. I'm not endorsing him, might be worth a search on this site to see who has mentioned him and what experiences they have had.
Hope4all,
Thanks Brother.
TWC
johnlee
Thank you for posting on FORUM XIAFLEX RESULTS
What make you to think that:
QuoteIt seemed I received distilled water instead of xiaflex in the 2nd cycle.
Did you told the doctor about that?
James
James,
I haven't had a chance to tell my doctor that the second cycle made no improvements. I will be seeing him in end of May and I will tell him.
Thanks.
I had my 4th round of Xiaflex shots yeaterday and the day before. My doctor told me that based upon new data, he wants me to use traction for one hour each evening that I got the shots as opposed to waiting 48 hours from the second shot.
I do not recommend that you do what I did but here is what I did. I did traction for two hours both days as soon as I got home, about one hour after each injection. Last night, the same day as my second shot I had sex with my girlfriend. Very slow and very careful, missionary position for about 15-20 minutes. When I say careful, I mean very careful on both our parts. No damage whatsoever.
Do not think I a recommending this, I am just reporting what I did. I have always lived on the edge and I am very aware of where I am with Peyronies Disease.
After three rounds of the Xiaflex, I see some reduction in my dorsal curve but I have not measured it yet. I go back to my doctor in six weeks for and induced erection and measurement using a protractor so I will have results then. I definitly see thickening in the distal part of my penis which had narrowed from Peyronies Disease but I am not back to where I was.
My girlfriend says she can feel the increased thickness and she loves the dorsal curve as it hits her G spot. I am still freaked out about the dorsal curve so I am determined to get rid of it.
Man, you are very literally flirting with disaster. It's going to be hard to have sympathy for you if/when you have a corporal rupture. It's your penis and your life, but to so willingly fly directly in the face of explicit directions from the manufacturer NOT to have sex while you're receiving the shots ... well, it's your life. I know you think you're being "careful," but I guarantee you, no one who ever broke their penis thought "I bet on this next stroke I'll break my penis."
Nemo
Nemo, I can't disagree with you and I don't recommend that anyone should do what I did. I have held off since and will wait my full two weeks before having sex again.
Just because I got lucky this time doesn't mean I will be next time.
Hello Everyone,
This is my first post but I've monitored this board for years. Three weeks ago I had my first round of Xiaflex and wanted to talk about my experience thus far. My curve was tough to measure because it was right at the glans, but I estimated around 30 degrees. A bigger issue for me was sensory loss due to the plaque covering the nerves in that general area; at least that is what I presumed. This caused a dull feeling in the area where I lost the throbbing sensation during erections and while it didn't affect urination it did lessen the sensation of urine flow. That being said the sensory loss was by far a bigger problem than the bending, but I wanted to resolve both.
Round 1
Day 1
I received two injections in the largest plaque. Most of the bruising came from the doctor squeezing the area to expose the plaque so the Xiaflex could be injected. He did wrap the area and told me to keep the bandages on for about 4 hours. This seemed to help reduce the swelling. Not too much discomfort at this point.
Day 3
Now I went in for the second set of injections. These were pretty rough. I was feeling the pain from the first round by now and the bruising was really starting to show. This time he injected the smaller plaque that was near the north end of the glans. This one was more difficult to inject because the plaque was small and very dense. Fortunately, the doctor has performed over 50 of these procedures and was able to inject the plaque without much problem. Which was a relief because just stretching out in a flaccid state was very painful at this point. Again, he wrapped it up and I went home. There was significant bruising when I removed the bandages this time. Swelling was also present but not too bad. Mostly black and blue over the whole shaft.
Day 5
Went back for the molding procedure this morning. By now I'm swollen and solid lack and blue. The head was the only section that resembled a normal color. However, it sounds like the typical experience from what I've read on this forum. Pain was not bad if I just left it alone but I needed to do the stretching which was painful.
3 weeks after first injection.
All of the bruising and swelling is gone. The bend is hardly noticeable. If I had to measure it I'd say less than 10 degrees. The area is fuller now when erect and resembles the shape it was prior to peyronies. The sensory loss has improved but is not fully recovered at this point. If I had to gauge it I'd say 50% restored. I suspect that's because there's still a small amount of plaque in the area. I noticed the improved sensation during urination and during erections. I've refrained from intercourse even though I'm past the 2 week restriction. This is mainly because I still have some soreness after erections and I don't want to do anything rough yet.
I'm debating on whether or not I should go in for another round. I think dissolving the rest of the plaque might restore a little more sensation. As for the curve I don't expect to see much difference. It's reduced enough now where I'd have to point it out to a woman and even then they probably wouldn't notice, or care. Much of my decision will depend on when the post erection soreness resolves. The erections are fine but the area is tender for most of the day if I maintain an erection for several minutes. I have a follow up with the doctor in a couple weeks. I'll see how I feel by then.
I hope you find this information helpful.
My physician is Dr. Rafael Carrion. I'd highly recommend him for anyone in the Tampa Bay area.
I have not posted any updates in this thread since my 8th injection from February of this year. I went back to Mayo about 6 weeks after the final injection for measurements. With erection, I was measured at 45 degrees after starting with 69 degrees. My pain has been lessened in both a flaccid and erect state, and my hourglass indentation is completely gone.
I was approved for more injections by my insurance company, so I went back in June for #9 & 10. I just received injections 11 and 12 this week and was met with quite a surprise. I am not sure if any of you currently receiving injections are having this new twist in the procedure or not.
The PA told me prior to #11 on Wednesday that they have begun to induce erection prior to the Xiaflex injection for those who have plaque 2-3 cm or more from the shaft/glans intersection. Their reasoning is that instead of making an educated guess about where to inject, the erection allows a more precise location to inject the Xiaflex. Here are two observations that I have from the last two injections.
OBSERVATION #1 - I had SIGNIFICANTLY less swelling from these two shots than from any of the previous series or individual injections. My guess, if I had to make one, is that there is less "collateral" damage to capillaries, veins, tissue, since the majority of the drug is going into the plaque.
OBSERVATION #2 - I have had more than 50 total injections into my penis between Verapimil and Xiaflex. These two were EASILY the most painful. I have two theories on this - the erection caused the plaque to be more sensitive OR the injections were more "on target" into the sensitive plaque.
If you read my post in this thread from Feb 15, you can read the procedure that I use post-injection for modeling and for traction. After injection #12 on Thursday, the traction device kept slipping off on the ride home. Frustrated, I grabbed the head of my penis with my thumb and index finger and pulled straight for 30 seconds. I would then let it rest for 30 seconds and then use a different technique for the next 30 seconds. On this second pull, I used my thumb and the side of my middle finger, and twisted the head down at about 90 degrees, while maintaining a "pull". The middle finger acted as a fulcrum under the location of my plaque.
After doing this for about 10 minutes, I started having a sharp, precise pain in the location of the plaque while I was doing the "fulcrum pull". I kept the same pressure on, fighting the urge to stop, and felt a slight increase to the angle of the head. I believe that this was the plaque tearing.
I am now 2 days post-injection #12 and have been applying traction twice a day for an hour minimum, plus doing the same pulling techniques 3-4 times per day, with 4-6 of each pull. I am very anxious for the swelling to go down so that I can see if there is any further reduction of curvature.
Pointedly
PS - I think that this is a great forum for us to share ideas and experiences that have to do with the treatment of this disease. I have said before that those of us who are getting Xiaflex injections are essentially part of an extended clinical trial. We also are blessed to have moderators who are both helpful and extremely patient. I would make a poor moderator and here is why:
I have taken the time to help others as they have helped me. I am typing away tonight while my wife asks me if I am "posting, or writing a book." I felt as though I have wasted my time with someone who I directly helped, who also felt it necessary to point out more than once that he ignored the Xiaflex protocols and had intercourse almost immediately, post injection. Info like that is neither instructive or necessary. I have been in many locker rooms in both high school and college sports and was never impressed by what amounts to "locker room talk". I am less impressed as an adult...
Pointedly,
I am not so sure that you would make a poor moderator , the fact is I think we all moderators and members like have days of feeling frustrated or defeated when trying to help or offering advice to those who simply wont take it. That being said, every time we come in this forum and every time we offer our help, there is always going to be someone it DOES help, maybe not that day that minute but someone will come along and need the advice you gave. Those of you who have the experiences with the treatments and the long standing diagnosis of Peyronies are the best moderators because you can give first hand advice from experience, its not a moderators job to MAKE someone take the advice, its only our job to be here and offer what we can when we can.
So don't be so quick to count yourself out. :)
Hugs Mamma
TonyStark - I could not believe my eyes when I got to the end of your post. I live in Venice, Florida and spent a lot of time and energy searching for a Xiaflex doc in Sarasota and nearby counties. After much phone time to Auxilium/Endo, I finally found a very experienced and highly reputable doctor. I see him in a month ... Rafael Carrion. Ha! How great is that? Actually, the Endo rep who helped me track one down said Carrion has had over 100 referrals from other doctors. Apparently he is THE Xiaflex man to see in Southwest Florida, or indeed farther away than that.
FYI, guys, as of two days ago, the Auxilium Xiaflex Hot Line was "out of order." The Endo folks told me there's been some communication glitches since the takeover. However, I can't say enough good about the Endo folks that worked with me, transferring me around, trying to get me to someone who could help me find a highly experienced doctor. They're not allowed to make recommendations, of course, but they can tell you how many referrals doctors have had.
This came about because I located a Xiaflex practitioner in Port Charlotte and he examined me and said I was a candidate. I was shocked and delighted to learn that insurance would cover it. But then the next day I did some investigating, because the uro made a couple of errors, like saying in my record I had a superior bend when obviously I have a lateral bend. After finding that he's been sanctioned by the State and fined for malpractice, plus lost two malpractice suits, and learning I would be only his 3rd Xiaflex patient, I opted not to have this guy sticking needles in me. Those of you who've read of my bromelain injection experiments know I'm not needle shy, but I'm scared to death of a doctor who's had 3 malpractice cases.
I'm looking forward to meeting and being treated by Dr. Carrion, Tony. I'm glad you found him worthy of his reputation.
Finally got in to see Dr. Rafael Carrion in Tampa. He's much in demand. My Peyronies Disease doctor in Baltimore, David Fenig, who himself is excellent, tells me Carrion is highly respected. I found him thus far to be worthy of it. He's engaged, he listens, asks many questions, does a thorough examination, does not patronize and gets to the point.
I've worsened, I believe, to 40º lateral with soft plaque running nearly the length. He's recommending the Xiaflex protocol, and I'm waiting to be contacted by Bio-something-or-other, the manufacturer, apparently. Insurance approved the treatment with another doctor previously, but I decided to go with Carrion, so the carrier must once again approve coverage.
I have confidence in Dr. Carrion, hope to begin the regimen soon and will post results.
That is so nice to read. Hope you are lucky with xiaflex. Looking forward for your future updates.
Gringo
US Bioservices is the ne of rhe specialty pharmacy that will contact you. I went through a similar process.
These US Bioservices people are a total pain in the ass. This woman "Kim", who won't give her full name, keeps saying she'll get back with me yet does not. I left a message one morning at 8:30 a.m., and when she called at 4:30 she admitted not having listened to her voice messages ALL DAY. It's been THREE WEEKS since my exam with Dr. Carrion and still the USB people are dragging their feet and doing nothing. I don't know why the doctor puts up with it; he doesn't get paid until I get injections. From my experience thus far, the USB people couldn't manage a picnic. Very irresponsible and unprofessional. Unfortunately we have no choice. And try finding the name of someone to complain to. Check their webiste. The last thing they want to do is give you an avenue of complaint. It's like a secret company. They have no interest whatsoever in the patient. American medicine has descended to a sad level.
I am considering undergoing the Xiaflex injections. I would like to learn more it, and also to minimize the side effects. It would be greatly appreciated if guys who have already had it could respond to any or all of the following questions -
1. Did you get a painkiller before the injection or just have the injection? Did the doc induce an erection and then take it down a few hours before the injections?
2. How long does the actual injection take? Did you experience much injection pain?
3. I know the doc wraps the penis after the injection, but did you ice it (before or after the injection)? How soon afterwards, and for how long?
4. Did you try to keep the penis north after the injection, so that any blood would drain down and not towards the head of the penis?
5. Did you wait 1, 2 or 3 days after the first injection to get the second one?
6. Did the doctor do in- office hand modeling after the second injection? How about after the 2nd, 3rd and 4th visit? How many days after the injection did you wait for the modeling?
7. After the injections, were you able to go about your daily business or did you have to recover a bit?
8. Did any of you go for any more cycles after the 4th visit?
If you have any other helpful hints, that would be great. Moderators -- I know that there is a lot of information in the threads, and I have read a lot of it. But it would be helpful if we could have a fresh, active discussion and information gathering on this subject. Thanks.
Update on U.S. Bioservices: I found the name of a VP and e-mailed him this morning, and I got a call later this afternoon. He'd lit a fire under somebody, and they were effusive in their apology and going out of their way to expedite the process. This is a great restorer of faith in USB. I've waited over 3 weeks for a simple insurance approval. The problem is my insurer leaves Florida at the end of the year. With six-week treatment cycles, if a 2nd cycle is called for, it must be approved by the insurer by the end of the year. Time is therefore of the essence.
Luckett: I've yet to, but hoping to shortly, undergo the injections. I have, however, as you can read in my other posts, experimented with bromelain injections. I had "remarkable" results, as my doctor put it, but which did not last, unfortunately. I can tell you not to be concerned about the actual needle sticks. The tunica has few nerves, and you'll feel no more pain in the dermal layer then you would in, say, your arm. Now as to any pain that may be caused by the drug, I cannot say. But the needle stick itself is nothing more than a pinch.
Daved2 - I suspect we have similar conditions: soft lateral plaque appx. 40º. It's been a month since your injections, no? Any change?
I was just reading elsewhere that the lateral tunicas are the thinnest portions, and some doctors do not recommend injection there. However, they also said true lateral plaques are rare. One urologist said I had a soft dorsal plaque, yet my bend is distinctly left lateral. Rafael Carrion in Tampa is recommending the Xiaflex, and obviously he knows his stuff, so I'm anxious to see how he approaches injecting into soft plaque .
Here is my experience so far. I completed round one, two weeks ago. I start round two in four weeks.
I am considering undergoing the Xiaflex injections. I would like to learn more it, and also to minimize the side effects. It would be greatly appreciated if guys who have already had it could respond to any or all of the following questions -
1. Did you get a painkiller before the injection or just have the injection? Did the doc induce an erection and then take it down a few hours before the injections?
No painkiller prior to injection. The pain is temporary and tolerable. My doc induced erections in the early stages to explore plaque by utilizing Doppler. I do not believe that process will become necessary again.
2. How long does the actual injection take? Did you experience much injection pain?
The first one took about 25 seconds because the plaque was difficult to penetrate. The second took less than 10 seconds. Not much pain. I did experience significant bruising and some swelling after the first shot. I experienced very little bruising and swelling with the second shot.
3. I know the doc wraps the penis after the injection, but did you ice it (before or after the injection)? How soon afterwards, and for how long?
I left the wrap on for 24 hours as instructed, no ice was used and was not recommended.
4. Did you try to keep the penis north after the injection, so that any blood would drain down and not towards the head of the penis?
No
5. Did you wait 1, 2 or 3 days after the first injection to get the second one?
One week.
6. Did the doctor do in- office hand modeling after the second injection? How about after the 2nd, 3rd and 4th visit? How many days after the injection did you wait for the modeling?
I started the day after, no in-office modeling. 3 x per day 30 seconds as indicated, straightening during morning erections.
7. After the injections, were you able to go about your daily business or did you have to recover a bit?
Resuming daily business was not an issue.
8. Did any of you go for any more cycles after the 4th visit?
N/A
If you have any other helpful hints, that would be great. Moderators -- I know that there is a lot of information in the threads, and I have read a lot of it. But it would be helpful if we could have a fresh, active discussion and information gathering on this subject. Thanks.
Key Point: I would make sure that you have a Urologist that has a lot of experience and a successful track record administering Xiaflex injections. My Urologist has changed his protocol based on many months of observation and experience.
Best of Luck
Very helpful ---thanks BX
Agree with that. Very informative post. Thank you
Does anyone know a good Urologist that has a lot of experience and a successful track record administering Xiaflex in northeast Florida? Thank you in advance!
Leonard - If you don't find anyone in NE Fla., I can recommend Rafael Carrion down in Tampa. As I gather, he's nationally, if not internationally, respected in Peyronies Disease treatment. My uro back in Baltimore said Carrion is a "name" in the field. I'm making the two-hour drive up from Venice to see him. I've met him once (see my earlier post), and have confidence in him.
I learned yesterday that I've been given the green light by my insurer, Assurant, for the first cycle. They're picking up 100%. What a relief! I've got soft lateral plaque running the entire length. Carrion said the big question with mine is where exactly to put the needle. I'm suggesting to him we do multiple aliquots along the entire length.
The only problem with Carrion is that he's so much in demand it's hard to get in. He'll be out the entire month of November, so they can't begin injections until December. I can't wait to see the results.
Gringoviajero thank you very much for your response. I will give them a call.
Thanks again,
Leonard182 - You might want to check with Dr. Broderick at Mayo Clinic in Jacksonville, FL.
Gringoviagero, thank you so much for sharing that info with us. Hope you have a good outcome when the time comes!
4 weeks post first cycle injections. No improvement whatsoever. I'm very cynical about this whole process. I believe Auxillium is so fearful of lawsuits that they urge the doctors to take a very conservative path. Doctors too are afraid, I suspect. It seems many doctors are not following protocol by doing in-office modeling, probably for fear of a rupture. Auxillium's patient modeling instructions use the word "gently" excessively to cover their collective ass. We're told to do nothing for 2 weeks. I suspect the reverse is true, that the drug is the most active and, thus, the most effective from the outset, and that immediate modeling is the best. That's why the protocol calls for physician modeling. But the doctor's aren't doing it, probably because they don't want to be sued either. I'd like to see a time-line graph of Xiaflex' effectiveness, but that's not going to be made available to us, is it? We don't have enough information, and it borders on deception.
Update on Treatment with Concern:
I had the second injection of round 2 a little more than two weeks ago. I have two areas of concern, Plaque at Proximal (next to base) and Plaque at Distal (directly below head). Plaque at base seems somewhat soft without pain, however, distal plaque has become painful to the touch and painful during erections. I have not had sexual activity since my first injection occurred, but I have consistent night time erections and some sporadic erections throughout the day. Once my erection starts it is a little painful, but if I attempt to bend my penis back into place the pain is sharp. I have seen some curvature improvement but the last time I had the injections I could go back to sexual activity after the two weeks had passed. Has anyone experienced this? I feel as if I am back in the chronic stage. I am anxious to slowly get back into things but I am concerned about potential damage.
I have a 30 degree curvature got approved by insurance for xiaflex treatment, however my insurance expires on january 1 and my new insurance (medicaid) wont cover this. Basically, I have to get better insurance by January 31 to have this procedure but now after reading some of these horror stories, I am skeptical of even going through with this. Can peyronies get worse if untreated and if so, how fast does this disease progress? How long is the total treatment? How many injections does a round consist of? how many rounds are in the total treatment? my doctor kind of rushes me along when I ask these questions but I do trust him and he has all my info/pictures and has pinpointed and photographed markings of precisely where to inject. He has told me that to do this the right way I will basically need 2 courses of treatment. I am afraid to wait for this because I'm not sure if the injection site will change as this progresses. I have a few weeks to make a final decision. Any advice?
Jay - I'm 33º left also. I posted below. Each cycle consists of 2 shots a day or two apart, with some doctors modeling you in-office following, others not. 4 cycle max. All this info and more is available on Auxillium's site.
I think the risk is low or the FDA wouldn't have given the green light. Horror stories make better press. Only 5 guys out of more than 1000 had ruptures. I can live with odds much worse than that. My next year's insurance won't pay either, so I got in just under the wire with only 2 cycles possible. It would be worth it to move to a new state just for the insurance to cover this. I got my EOB today, and it was $15K just for the drug!
You can talk to U.S. Bioservices, the folks who handle the drug distribution to doctors, and they'll tell you what doctors have had the most cases near you. You may have to cajole them.
Hello,
Age: 29
My Peyronies Disease began on September 4, 2014.
I have just finished both shots of round 1. The first shot was very painful but the whole thing was over pretty quick and did not hurt afterward.
The second shot did not hurt at all but there was a little more pain later throughout the day. I am very bruised and swollen. It doesn't not appear that my thick cord of fibrosis tissue has been diminished at all. I am not sure why. I will update in 2 weeks.
Hi all, great to a see a forum like this.
I just completed my first cycle of Xialflex shots (injection 1 and 2) and the third modeling visit. My experiences were much the same as most folks here Not much fun on the shots, but had minimal bruising with soreness at the injection area. I'm about 3 weeks out past the 2nd injection and during the home modeling I'm still experiencing pain around the injection point. No trouble getting erections but experiencing pain at the bend and pain when trying to "model" by putting pressure against the bend. Of course all are scared of the corporal rupture (so at the very least I'm super sensitive). Has anyone else experieced prolong pain from the injections or pain with erection for a period (after the injections)?
Thanks guys!
Shute - I'm 6 weeks out of the first cycle; go in tomorrow for the first shot of cycle 2. Yes, I had the same reaction to my first cycle. I started with the VED after only 3 days, got scared and stopped from the pain, then resumed at 5 days, then stopped again a week or more later out of discouragement. The whole thing is stressful because it's hard to know what to do. What they tell us is obviously (to me and others) not the optimum procedure because of their fear of litigation. This next round is my last chance because of insurance reasons. I'm going to try consistent modeling, not too aggressive, but firm, and beginning the day of the injection. I'll be pre-heating, doing the protocol stretch and bend, using a stretch strap and possibly VED. Very stressful. Not enough studies and too much concern for protecting doctors and Auxillium from lawsuits.
Great. Thanks Gringo. I agree. Very stressful and sounds like there's a pretty wide range on how each person's body is reacting. Lot's of moving pieces and variables that's for sure. I called my Doctor who had said the pain was normal and he would expect it to subside with more time. Basically the same thing....each body reacts a little differently and may take longer to heal. Appreciate folks sharing their experiences. My 2nd cycle is set to begin in mid February. Just got the news that my out of pocket was going to be $1,700 due to the change in insurance year, Yikes! Had only paid $150 out of pocket for the first cycle. I guess just another challenge in this process. I'll keep folks updated on my ongoing experience as well.
I wanted to give an update on my progress. I had my second injection in November of 2015 and it will likely be my last. The second cycle didn't have much bruising at all. However, the second round of that cycle was very painful. It's pretty much resolved now and my results are as follows.
Round 2 results
My bend is negligible at this point; maybe 5 degrees when fully erect. I've certainly seen some restored length and girth as well. For the most part it looks like my pre-peyronies days. That part I'm happy with.
The restored sensation is minimal. While it has improved it's not what I hoped for. However, I will say that intercourse is more enjoyable than before and I guess the bright side would be I can last for quite awhile now. This is just something I'll have to learn to live with unless they make progress in this area. I realize Xiaflex was not intended to restore sensation.
Round 3
After talking with the doc I'm going to hold off on round 3. While there is still some palpable plaque he's advised me to hold off since my bend is virtually gone. His concern is any negative side effects from further injections wouldn't be worth the risk. Since Xiaflex isn't intended to restore sensitivity I tend to agree with him. So I'm just going to go test drive this thing for awhile and see how it goes.
What to do now?
I would like some feedback from you guys regarding this. What would you do in my situation? The US Bioservices people have given me 3 months to decide if I want to go through another cycle.
My original bend was about 35 degrees at the glans. Now it's around 5 degrees but there's still some palpable plaque that could be injected.
Any thoughts??
Will be very useful that members will post they results and update they posted results according to the format on:
FORUM XIAFLEX RESULTS - Peyronies Society Forums (https://www.peyroniesforum.net/index.php/topic,6273.0.html)
It will help other forum members to decide to "be or not to be" a Xiaflex shutter :)
Thanks
James
Tony,
I guess your biggest question is one for your URO, which is: Is there any way the sensation gets better after another round? Will the plaque be completely gone after another round? Can the plaque come back after this round assuming no other injuries occur? If your URO says yes to #1 and #2, but no to #3, then it might be a no brainer.
Tony, had my 1st shot of the 2nd cycle today. Dr. Carrion is terrific. He spent a very long time with me; I had several questions and issues to discuss. I recommend him without reservation. Peyronies Disease is all he does. He is the go-to Peyronies Disease man in Florida (and not to be confused with another "Rafael Carrion" in Miami). I drive up to Tampa from Venice and would go twice that distance or more for treatment from him at USF Health.
My plaque is soft but extremely dense. Carrion said it was like trying to get a needle into a tendon. Mine is a difficult case. If Xiaflex doesn't work, it's not for want of trying.
Has anyone's curvature gotten worse after Xiaflex injections? I am about one week out since my Xiaflex treatment and the curvature of my erection has gotten worse than before I had the Xiaflex treatment. My doctor told me this is a normal thing a week in and to continue with modeling but I'm looking for others experiences and opinions on this.
Thanks
Mr. Wood, coincidently I put that same question to Dr. Carrion just yesterday before my injection. He said his group, USF Health, Tampa, has had only 2 cases. This is out of a very large number, in the low hundreds. The modeling is critical, no less important than the drug.
It's not normal at all to get a worsening of the curvature. If I were you, I would not believe anymore in your physician. Get other opinions from other experts.
At one week you're still unstable. Your penis is going through changes. Do the modeling religiously and don't be shy about it. Auxillium was extremely conservative with their protocol in order to get approval. You can put some muscle into it. At this point you have no other choice than to continue doing what you're doing until your six-week follow-up. I'm 3 days out from my 2nd cycle. On the first cycle I had no improvement at all. But the chances of your worsening are very very slim. Give it time and do the stretching.
For those who have gone through Xiaflex treatments and seen results.... How long after completing the cycle (whichever one it may have been that brought improvements) did you start noticing a difference in curvature? Since it's recommended to avoid sexual activity for at least two weeks after, I'd imagine this means the xiaflex agent is still active and working throughout this period. Did people see results after only a couple days? Couple weeks?
Thanks
Mikey
The swelling can hide what's going on, distort it. It will be only after the tissue has calmed down that you'll be able to get an idea of how you're shaping up. And because the drug is still active for weeks, just because you don't show improvement soon doesn't mean you won't see positive results after a few weeks of modeling. It takes time.
The results vary a great deal in each case, in my opinion there are two basic factors: 1. the condition of the plaque and curvature. 2. the skills / experience of the urologist. I completed 4 cycles in September last year with self modeling along with using a traction device. Started from 38 degrees. By the end of the cycle, it was 30 degrees. $28K USD to reduce 8 degrees. I can't say it's a huge success for me, but any improvements are welcomed. The lesion didn't change at all. For me it's a long hard cord on dorsal, covering the entire shaft. Uro said I have to live with it for the rest of my life. I have read somewhere that a Mayo clinic Uro suggested using traction device within 24 hours because Xiaflex is at its best within approximately 48 hours. My uro was conservative and didn't approve traction until 2 weeks after each cycle, but I did it within 24 hours albeit my organ was bruised and swollen. If I didn't use traction, perhaps my results could have been even poorer.
X2 - I'm glad you wrote; I couldn't agree more with your speculations. I've had discussions with my doctor and done what I can to research this, and I've some experience in clinical trials. From what I've learned, there's much going unsaid from the providers' and producers' side. There's so much money involved, to say nothing of the fear of litigation, that things are being distorted. And I myself hesitate to say what I've learned for fear of causing problems to those who've helped me.
But I can give my opinion and my speculations. A lot was riding on the FDA approval of Xiaflex and so an extremely cautious protocol was designed to give the best chance of success, not successful outcome of the patient, but successful FDA approval. There are contradictions, e.g. the patients are told to wait 2 weeks to model, yet the doctors are told to model immediately afterward, and they do so quite aggressively. What does that say? My thinking, and my recollection from organic chemistry many years ago, is that the drug is active from the time it enters the body. I've searched for an activity timeline graph and found none. My guess is that within a day the drug has penetrated the collagen and begun softening it, and that modeling should be done right away. I'm guessing, too, that two weeks post-injection the effectiveness has greatly diminished, i.e. what we're instructed to do is the opposite of what we should be doing. The emphasis is on avoiding a fracture, but only 5 of 1055 subjects suffered a rupture. Auxillium's instructions are not meant to give us the greatest chance of success but to diminish as much as possible their vulnerability to lawsuits. Else, why are doctors told to aggressively model us within 24 to 48 hours?
Like you, I have soft plaque running the entire length. See my other posts for details. My first series produced nothing. After the 2nd cycle I immediately began aggressive modeling with a variety of methods (manual, stretch strap, VED) and now I'm seeing results. I'm 12 days out. I believe by the two-week mark, when patients are told to begin modeling, the drug is so weak that it's a waste of time. I believe modeling should begin right away and last only 3 weeks at most. The entire protocol was designed around getting FDA approval and not in the best interest of patients.
gringoviajero - thank you for your reply. I really appreciate your feedback and sharing information and opinions. They are helpful to me and hopefully to many other Peyronies Disease patients seeking Xiaflex treatment as well. You are absolutely right: Xiaflex is the most effective within 24 hours after the injection. It starts to wear off after just one or two days. It has no effect after a week or so. Thus, starting modeling ASAP is extremely important. Also, an experienced uro is essential.
My Peyronies Disease is still bothering the hell of me although I have had some improvements after completing the 4 cycles. For me, 30 degrees curvature is unpleasant but my wife and I can live with it. Shortening and wasting caused by the cord like lesion make me feel very miserable daily! If I could be treated with a few more injections, I believe I will see more improvements, but for the time being, it is unlikely to happen.
I hope the rest of the cycles will go well for you and you will see better results! Keep me posted please.
X2 - Is your determination that the drug dissipates quickly based on your experience, or have you come across some information about this? I've searched to no avail to find a timeline graph or table showing enzymatic activity plotted against time. I suspect these data are known but suppressed.
It's funny you posting this x2.
I was on a trial in the UK some six months ago and achieved good results.
The protocol then was two injections/wait two weeks/VED or modelling/four week gap. Total of four cycles like this.
Only today I rang to speak to my consultant who did these about further injections which, if I decide to go ahead, I will have to pay for.
He was quite open about it and said that he didn't think the protocol above we used for the trial was in the best interests of the patient. If I go ahead, his treatment now would be one injection/VED immediately twice a day for a week/then same cycle after six weeks x 2. In other words three single injections, immediate VED for a week after each with a six week gap in between.
This would certainly seem to support your argument about how and why the protocol was put together for the trials.
And finally a confession which would seem to support this even more.
Although we promised we would follow the trial protocol to the letter, I didn't, and started using the VED immediately I got home from having an injection.
Surprise, surprise my improvement was one of the best on the Trial.
Ive - that's my game plan for the next cycle, my third. I've been doing the manual stretch 2x/day (but more aggressively and for longer), VED 1x/day, stretch strap 2x/day for 2-3 hrs. The manual stretching and VED are preceded by 20 minutes of heating.
On the next go-'round I'll do VED 2x/day, as you say. All this starts the day following injections.
gringoviajero - I remember clearly I read some one's posting about using traction device on the same day of the xiaflex injection. Perhaps it was quite sometime ago and the posting might be deleted by the author? (I searched it too, using keywords such as xiaflex - traction - mayo, but I couldn't find it). I can assure you it was a Peyronies Disease patient who was given Xiaflex at Mayo. There was no detailed graphs or such. It was merely a remark in passing. I also remember he said he put on the traction device in his car when he drove home from Mayo and one day the traction device fell off (something like that) because his plaque was stretched longer.
My uro was against using traction soon after Xiaflex injections as I mentioned here. He emphasized that VED is more risky. So please be careful with VED after the injections. Traction seems a bit safer especially if you don't increase the tension too much.
Good luck!
Not just Xiaflex , but using VED immediately after any kind of injections.
I done it after one of my PRP sessions and I had to stop immediately because blood was sucked out from the injections little holes.
I think the PRP also!!!
James
James - Yes, I agree. I should have clarified my protocol. Using a VED soon after injections would result in blood leakage, no doubt. That part of my protocol ought to wait 48 hours, I should think. However, I think it has been beneficial as it creates pressure from within in all directions, not just linear, which is all stretching does. Also, what I do is, after removing the VED, I grip the base and the glans very firmly, putting blood pressure on the central shaft, and bend it opposite my curve. This creates internal pressure against the plaque.
I think approaches for soft plaque treatment must differ from those for hard plaque. Hard plaque is like a callous with borders and easily defined. X2 and I have soft plaque covering a large area. As Dr. Carrion says, it's like having a tendon in your penis.
gringoviajero -
I have been puzzled for 3 years since I was diagnosed with Peyronies Disease. Since you were saying we had similar plaques - tendon like plaque in our organs. I would like to share my experience with you.
Here is my story of how the "tendon" was formed: At first, I felt a slight pain in my organ when it was erected. I didn't think too much about it. One day, I felt a nodule on dorsal near base in the size of a grain of rice. I googled penile illnesses and figured out I might have Peyronies Disease. I went to see a uro and he confirmed it. Since the nodule was small and there was no curvature back then, uro told me wait and watch. In about 3 months, I started noticing a curvature of 20 degrees, but the nodule size was unchanged. I was worried that it would get worse. Uro recommended Verapmil shot. So I went through 5 Verapmil shots. I felt the nodule became bigger and longer each time after the shot. I decided to stop the Verapmil shots. Soon after the Verapmil, I noticed a cord like thing (or the tendon so to speak was formed from the position where the original small nodule was ALL THE WAY to distal. My Curvature turned into 46 degrees!
I don't want to blame my uro for this. His intention was to help me. Whether or not Verapamil turned a small nodule into a long, hard "tendon", about 1/4" wide and covers the whole shaft and 45 degrees upward curv, no one will ever will get to the bottom of it.
I am just wondering how your "tendon" or the hard cord was formed? Did you have verapamil shots?
I read stats somewhere only small % patients had benefit from Verapamil. Some got worse. I am pretty sure I belong to the group that Verapamil made it worse.
I got better on my own after I stopped Verapmil. 46 degrees reduced to 39ish WITH NO TREATMENT after about one year. Then I had 4 cycles of xiaflex. Now I am at 30ish degrees upward bend. The other difficult problem I have is the shortening. I lost 1.5". Clearly, the tendon is pulling the shaft to make it short.
I feel the Xiaflex was merely doing damage control to the adverse effect that Verapmil has caused.
I will appreciate it very much if you could tell me how your plaque was formed. Did it have anything to do with Verapamil shots.
Thank you in advance!
I've not taken Verapamil. My initial symptom was painful nocturnal erections. There was no palpable plaque back then. After two years the curve began and the soft plaque could be felt. I wasn't officially diagnosed until 2 years after that, 5 years after the initial symptom.
I've no explanation as to why it formed, just as most sufferers have no explanation. I don't remember any injury, and my father says he has no curve.
My 2nd Xiaflex cycle has helped bring me down from 33º to perhaps 25º, and it has changed the shape slightly. I did vigorous pre-heating and stretching, VED and stretch-strap after this 2nd cycle. I have the 3rd cycle coming up in a month. I've regained the length I lost to Peyronies Disease. The doctor was very aggressive with the 2nd cycle. I think one cannot treat our plaque lightly as it affects a large area of tissue. The drug must be dispersed broadly and the modeling begun the following day and done aggressively. I am not concerned with rupture.
Thanks for your reply gringoviajero.
You said your doctor disbursed xiaflex broadly. Did you mean it was injected into multiple locations of the long plaque? My doctor injected xiaflex into one spot for each injection. All 8 injections was at the same spot. He determined the spot by finding the most curved point from an induced erection. The 4 cycles reduced 8º. I asked the doctor if it's possible to inject into multiple locations since my plaque is about 4" long. The answer was no.
I am glad to hear you have much better results. 33º to 25º after the 2nd cycle - that is a lot of improvement!
Your approach was exactly the same as mine. I asked him about giving aliquots along the entire length, and he too rejected the idea and focused on the indentation and interior angle of the bend. When I say dispersed, I mean instead of inserting the needle into one location and drawing it out while injecting, as is done with hard plaques, he penetrated the skin at one point, but then inserted into the tunica at various points. I understand his approach; the primary concern is relieving the bend.
I believe you're right in thinking that injecting the drug along the length of the plaque followed by aggressive stretching would restore your lost length. The problem is they have only a small amount of drug to work with. If cost wasn't such a big factor, I think their approach would be different, they would be much more liberal, particularly in soft plaque cases like ours.
If you have the opportunity to get the drug again, I would suggest a serious conversation with the doctor about dispersing the drug over a broader area in the neighborhood of the bend, making several punctures of the tunica. Our plaque can't be treated like the others. And I would begin modeling next day. I've explained my regime in previous posts. Heat is important. That's not speculation but based on studies of heat and cold on colagen. Heat not only softens the fibers but increases enzymatic activity. Heat before stretching and heat before the VED. I go to bed with a stretch strap and it wakes me after 2 or 3 hours and I remove it. It's not harmful and not uncomfortable.
gringoviajero, thank you again for your post. I highly doubt that my uro would give me more xiaflex treatment because: 1. the insurance will not pay again. 2. my curvature is now at 30º. It has to be greater than 30º to qualify the treatment. I have continued using the traction device since the completion of the 4 cycles. I have not seen improvements but I will keep trying.
Thank you for the tips on heat. I am going to use heat before I use the traction device from now on. It makes a lot of sense, especially I live in a very cold climate.
X2 - The 30º threshold is for the trials, not treatment. The physician is supposed to stop treatment when you reach 15º. Your issue is just money.
Moderated - Please don't make duplicate posts.