Thread for Guys in Xiaflex Trial - Currently or Previously

[BSSS]

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.

[Ben]

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.  

[Worried Guy]

Was that 5% in total or from the 1st cycle. I guess you have modelling to come yet so the angle may decrease further!?

[BSSS]

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.

[BSSS]

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.

[Worried Guy]

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?

[UK]

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.

[Worried Guy]

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.  

[saramon]

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.

[Ben]

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.

[BSSS]

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!

[Humorous3]

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

[restore]

Thanks for the update.  Did you have any hourglassing or reduction in girth?  If so, has that improved?  Or too early maybe.

[BSSS]

Great news Humorous,

Glad to hear you improved that much, very impressive.

[bigk]

A 35 degree reduction is really amazing... it certainly gives me some hope.  Thanks for the update.

[Xtrialguy]

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.  

[Worried Guy]

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.

[Xtrialguy]

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.

[waitingforxiaflex]

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.

[Xtrialguy]

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.

[Xtrialguy]

I developed a very dark blood blister...I removed the pic because I just didn't want it out here forever.  

[BSSS]

thought about a cold pac?

[BSSS]

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.

[skunkworks]

Get in touch with the doctors and insist one see you immediately. Don't take no for an answer.

[waitingforxiaflex]

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?  

[Tim468]

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

[MikeSmith0]

Wow - did things turn out ok?

[saramon]

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.




 

[bigk]

Thanks for the update!

[Xtrialguy]

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.

[newguy]

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.  

[newguy]

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.  

[Old Man]

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

[ohjb1]

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.  

[Old Man]

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

[BSSS]

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

[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

[saramon]

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

 

[taurian]

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!

[fubar]

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

[RFC]

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.  

[RFC]

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.  

[RFC]

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.  

[Worried Guy]

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.

[nycsurfer]

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]

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.

[saramon]

Hi nycsurfer

According to the instructions I was given stretching is done while flaccid and bending is done while erect

Regards

[ComeBacKid]

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

[nuschler22]

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?

[nycsurfer]

I ha e only gotten one round of shots but it hasn't helped with curvature or hourglassing yet.  Stay tuned....