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Welcome to J Francois Eid, MD - Directly answering member questions in the "Medical Professionals" section below the Treatment boards.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #100 on: February 24, 2011, 12:46:22 PM »

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.
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chefcasey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #101 on: February 24, 2011, 01:05:58 PM »

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.  

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GS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #102 on: February 24, 2011, 01:51:37 PM »

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
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Chopsuey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #103 on: February 24, 2011, 07:49:35 PM »

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
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Old Man

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #104 on: February 24, 2011, 08:11:28 PM »

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 Erectile Dysfunction 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
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Age 92. Peyronies Disease at age 24, Peyronies Disease after
stage four radical prostatectomy in 1995, Heart surgery 2004 with three bypasses/three stents.
Three more stents in 2016. Hiatal hernia surgery 2017 with 1/3 stomach reduction. Many other surgeries too.

fubar

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #105 on: February 24, 2011, 11:32:21 PM »

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
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #106 on: February 25, 2011, 02:42:38 AM »

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
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #107 on: February 25, 2011, 05:17:59 AM »

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.  
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chefcasey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #108 on: February 26, 2011, 04:31:46 PM »

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
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #109 on: February 26, 2011, 04:43:09 PM »

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
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #110 on: February 26, 2011, 05:46:19 PM »

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.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #111 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. 
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Brightdog

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #112 on: February 26, 2011, 06:04:55 PM »

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.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #113 on: February 26, 2011, 08:38:17 PM »

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.
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rd

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #114 on: February 27, 2011, 10:11:13 AM »

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.
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chefcasey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #115 on: February 27, 2011, 12:20:59 PM »

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.
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chefcasey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #116 on: February 27, 2011, 01:01:47 PM »

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.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #117 on: February 27, 2011, 01:36:50 PM »

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.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #118 on: February 27, 2011, 01:39:53 PM »

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.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #119 on: February 27, 2011, 01:52:14 PM »


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.
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chefcasey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #120 on: February 27, 2011, 03:33:31 PM »

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?
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Woodman

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #121 on: February 27, 2011, 05:48:42 PM »

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.
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chefcasey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #122 on: February 27, 2011, 08:22:52 PM »

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.
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ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #123 on: February 28, 2011, 03:55:10 PM »

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

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ComeBacKid

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #124 on: March 03, 2011, 02:49:55 AM »

When was it approved for use in the United States, I thought that happened like a year ago?  Does anyone know? 
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ComeBacKid

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Re: AA4500 drug testing has started for Peyronies
« Reply #125 on: March 03, 2011, 03:06:11 AM »

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
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ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #126 on: March 03, 2011, 03:29:07 AM »

Yea I think it was last Feb ...
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Mathewfamily

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #127 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.
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bummedout

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #128 on: March 07, 2011, 08:55:54 PM »

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.
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #129 on: March 08, 2011, 02:02:30 AM »

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
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Mathewfamily

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #130 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.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #131 on: March 08, 2011, 11:21:53 PM »

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
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Chopsuey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #132 on: March 09, 2011, 07:57:00 AM »

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.
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Mathewfamily

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #133 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.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #134 on: March 09, 2011, 03:55:48 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?  Erectile Dysfunction?  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.
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chefcasey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #136 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.
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #137 on: March 10, 2011, 11:08:53 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.
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #138 on: March 11, 2011, 01:37:26 AM »

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

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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #139 on: March 11, 2011, 01:46:46 PM »

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
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infiniti

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #140 on: March 13, 2011, 09:17:42 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".
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ohjb1

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #141 on: March 20, 2011, 06:25:10 PM »

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?
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ohjb1

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #142 on: March 20, 2011, 06:29:15 PM »

sorry, i should have said SAGGING, reddish blue skin
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #143 on: March 20, 2011, 08:52:04 PM »

i never had any negative reaction... not a good sign
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #144 on: March 20, 2011, 09:11:31 PM »

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.

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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #145 on: March 20, 2011, 09:27:19 PM »

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. 
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #146 on: March 21, 2011, 09:54:04 AM »

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.
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #147 on: March 25, 2011, 12:14:45 AM »

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

BSSS
 
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ComeBacKid

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #148 on: March 25, 2011, 02:42:55 PM »

BSSS,

For our members who don't know much about medical terms, what is an open label study?

Comebackid
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #149 on: March 25, 2011, 03:43:37 PM »


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
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