Xiaflex

[turbo]

Comeback, I think you answered your own question.  The study is for only 4 sessions at 6 week intervals.  If it took longer the results would likely not help them.

I am new to the forum but have been passively observing for awhile.  I was asked by my urologist to participate in the study.  I have two reservations about it:

1) I am presently around 11 weeks into my first VED protocol and am starting to see a very slight improvement.  If I join the study I will have to halt the VED protocol for around 6-12 months.  I am concerned I could be gambling either way since neither is a sure thing.  I feel like the VED has more testimonial evidence to support it but the study may be a unique opportunity.  I am leaning towards doing the study since I could always jump back to the VED once it is compete.

2) There is a 33% chance I would receive the placebo.  However, it states that "Subjects randomized to placebo may receive open-label AA4500 treatment after completing this study as part of another protocol".  I will decide next week and it will likely depend on what this statement means.  If I am guaranteed the real Xiaflex injections after the study if I end up in the placebo group I will very likely participate.

Turbo

[BSSS]

good luck Turbo with your decision.  I still haven't heard back from the office close to me re: the study.

Say, I did a search on collagenase and found a forum run by a drug manufacturer.  Is anyone familiar with this place?

http://www.biospecifics.com/DNForum/default.aspx?f=6

I hope my posting the link doesn't violate any rules, if so please remove!  

BSSS

[BSSS]

good luck Turbo with your decision.  I still haven't heard back from the office close to me re: the study.

Say, I did a search on collagenase and found a forum run by a drug manufacturer.  Is anyone familiar with this place?

http://www.biospecifics.com/DNForum/default.aspx?f=6

I hope my posting the link doesn't violate any rules, if so please remove!  

BSSS

well, after checking into this 'forum' a little more, I see it's not very active and not much help at all.  Sorry for the distraction!

BSSS

[BSSS]

well I did hear from the clininc in my home state that is one participating in phase 3 of the study and they set up an appointment for me in November.

To be honest, I'm still mulling it over.  Not sure I want to 'expose' myself to more people and have a needle injected into what penis I have left.

Will post decision/results later.

BSSS

[Humorous3]

About two weeks ago I read here about the Phase 3 study for Xiaflex/AA4500.  After checking the ClinicalTrials.gov website, I called the POC for my state and "signed up".  My initial appointment is this week.  I presume if all my tests go well (and I expect them to) I'll be enrolled in the study.

With my chances being 2 out of 3 to get the real drug, I guess that's not too bad.  Plus, just like Turbo said he was, I was given assurance that anyone receiving the placebo in this study will be given Xiaflex later if they complete the study.  (I presume this will be in writing.)  From reading the comments here of the Phase 2 participants, they were offered the same thing also.  

On the downside, I'm not real happy about someone sticking a needle in my penis.  I'll get a chance to experience that on my initial visit although it will be for a different reason.

I will, as others have in the past, keep this forum advised of my experiences in the study.

Humorous

[ComeBacKid]

I have two concerns regarding xiaflex.  One is will it actually work, to date we have yet to see some serious results to get excited about.  The second is will the insurance cartel industry actually cover it?  You know they won't want to cover an expensive treatment, and will find a bs reason to deny it and direct us to some other method of treatment that doesn't work.  I think we should be cautious until we get to excited.

Comebackid

[MikeSmith0]

have you seen the study exclusions?  it's insane.. i dont know how they are gonna find anyone...

no calcified plauqes is 1 huge problem.  though there is a statement about calcification being ok under certain circumstances, but it's not clear.  

i dont know why the woman on the phone at auxilium told me phase 3 was like 2 yrs away...it's starting next month.  approval might be a year (or more) away, but phase 3 is here.

as far as insurance not covering it... i think that'll be interesting for auxillium too because they want to charge $2000 per injection & no patient is going to come up with that cash for 6 uncertain injections.  they'll have to lobby the insurance cos more than we will... if they want to make a profit.  the MS drug injections are similarly priced, btw... and newer chemotherapy agents are way way more... though these are both life or death situations & people dont seem to think Peyronies Disease is as serious as it is for a person's life. it'll be interesting who makes this decision.

[BSSS]

I decided to go ahead tomorrow and be assessed by the local clinic that's participating in the trial.  If anything interesting occurs, I'll be sure to report!

[MikeSmith0]

BSSS, good luck w/ it.  Also, can you let us know if they do an ultrasound on you?   I am a little annoyed about the calcification exclusion (which can only be determined via ultrasound).  Also, when was your onset?  They want people < 1 year since onset... which is highly restrictive.

[Humorous3]

My lab test results went well.  The other tests, ultrasound, Doppler ultrasound, EKG, apparently went well also since I was accepted into the study.  The ultrasound is done while the penis is flaccid.  The  Doppler ultrasound is done while the penis is erect.  This test measures blood flow in the penis.  Then they measure the degree of curvature using a goniometer (a ruler that measures angles) to determine curvature severity.  (The minimum and maximum angles are given in the AA4500 study details.)  

Since the penis must be in an erect state for the Doppler ultrasound, and it is a drug induced erection, this is where the needle comes into play.  My biggest concern was the papaverine injection.  It was slightly painful going in and coming out but not at all as bad as I imagined.  Another thing that eased my mind a little was learning papaverine is used by some men as an ED treatment.  I thought if they use that instead of Viagra, how bad could it be?  Additionally, the needle gauge is pretty small.  

Another thing to mention concerning injections is they will offer you anesthesia via injection.  It didn't seem logical to me to get an injection to prevent pain during another injection.  In other words, if the first shot is going to be painful, why opt for two shots?  

Bottom line, I will start my first study treatment cycle very soon and I am looking forward to it.  

To those thinking about joining this study, consider enrolling sooner rather than later.  You don't know how many people will be allowed to enroll at the nearest location to you.  Slots will probably fill up fast.  

Humorous

[Humorous3]

BSSS, good luck w/ it.  Also, can you let us know if they do an ultrasound on you?   I am a little annoyed about the calcification exclusion (which can only be determined via ultrasound).  Also, when was your onset?  They want people < 1 year since onset... which is highly restrictive.

Mike,
You may want to reread the study criteria, especially Exclusion criteria 5.  To me it says if you have so much calcified plaque that they can't inject the study medication, then you will be excluded.  I don't see where it says you will be excluded if you have any calcified plaque.  

Considering the timeframe, Inclusion criteria 3 says to me your Peyronies should have started over one year ago.  In other words, your Peyronies should have stabilized before your first injection.  

If you haven't already, please read my previous message which addresses your question about the ultrasound tests.  I hope all this helps.  

Humorous

[MikeSmith0]

Yeah - I didn't cite it correctly in that post...I may qualify but will not know until after the 1st exam.  

Was your erection normal when you had the papaverine?   The doc injected me with that and I had the most bizarre erection which was far from 100% full, and the study excludes people under 30 degrees of curve.  When i am not fully erect, I am under 30 degrees of curve (it worsens as more blood goes in).  And I dont think I can be in the study if I cannot get erect from injected medication.  I'm fine w/ viagra - or even without it - but that injection really burns (to me at least) and is extremely awkward.  

Most of the centers don't seem to be taking appointments yet.  I called one, but I went through like 200 questions and now im gonna get called back at some point in the future.  So, I called another office and the same exact thing happened.  

Do you understand their exclusions around sex?  Like, you have to have a regular sex partner... but can you be using viagra every time?  Or, is that exclusionary?  

I just noticed that the consent form says they will only treat *one* plaque.  I have a lot more than one... I almost don't think I see the point in going through this (up to 19 visits to the office over 1 year - 4-5 ultrasounds in erect state, etc...) for 1 plaque... do you have more than 1 plaque?

[ohjb1]

I was in the prior phase of the Xiaflex trial. Received the placebo and the result was no change. I think many readers on this site are getting their hopes unrealistically high. There is no evidence that Xiaflex will be a cure or almost cure for our disease. Just look at the results posted on their websiste. At best, it may end up being an modestly effective treatment for some men with peyronies. Nothing more.

A new exclusion for this phase of the test is an hourglass deformity.  This seems absurd because almost all men with Peyronies Disease have this deformity. The participating urologist will certainly need some discretion or else will not be able to enroll anyone.

Remember, that Auxilium is an extremely small drug company with ongoing financial problems and probably is unable to design a state of the art clincal trial protocol.  

[ronners]

ohjb1 - I've been following the Xiaflex story for sometime - Whilst I don't think that it will be the answer to everyone's problems, I think the followers of this forum should be able to derive some comfort from the fact that there is an alternative to surgery that has progressed to the final stage of FDA testing ... Having read a number of related forums and watched online treatment videos, the drug works well with Dupuytrens patients in terms of breaking down and softening scar tissue - why not be optimistic for Peyronie's sufferers ...

In terms of financials, Auxilium is not in anyway dissimilar to other developmental biotech businesses in respect to the way that it finances the development of its products ... The company has a market cap of $1.2 billion and Pfizer has put down cash for distribution rights in Europe ... The parameters of the tests are clearly designed to provide clear and consistent results when it comes to FDA sign off if it gets that far ...

This condition alone is depressing enough thanks - Taking into account your points, I for one am looking ahead over the next 18 months with some optimism about this product ...

[MikeSmith0]

A new exclusion for this phase of the test is an hourglass deformity.  This seems absurd because almost all men with Peyronies Disease have this deformity.

Agreed - did you have hourglassing before?  Somehow my horuglassing got better on 1 side...so now it just looks like a dent.  I have no idea if the uro is gonna exclude me for that.  

It only works 40% of the time in the hand contracture disorder...so yes, our hopes may be too high...

My biggest fear is this "penile fracture" in the consent form.  What is THAT?  I mean, how do you repair that?  In the Duputrynes (i cant spell it) - there were people who needed immediate surgery after xiaflex caused some kind of breakage / tendon tears as well.  

[Woodman]

Wow.......Penile fracture is listed as a complication! Thats when the TA ruptures due to too much bending force on the penis during erection. " this usually happens with woman on top man slips out and woman comes down striking the penis with her pelvis etc."  Usually the penis goes limp immediately then the pain and the blood from the erection come up from the TA causing bruising swelling etc. It requires immediate medical attention. They have to drain the blood from the penis thats leaked from the TA, deglove the penis and repair the rupture or hole in the TA with stitches. Once the hole is repaired they induce a erection with saline to make sure everything is sealed up and theres a straight erection etc. Then they close the degloving incision.

If one does not seek immediate medical attention the condition usually turns in to Peyronies Disease & deformities of the penis.

I can see why they are warning this as a possable side effect from what I ve read about Xiaflex and Dupuytren's contracture. The doctors were giving the injections for a certain amount of time then when the scar tissue became weak they would pull swiftly on the effected finger snapping the scar tissue. Kinda like a rubber band thats been pulled past its limit. So in that regard I can see it weakening the plaque(s) in the penis then someone having an erection and it snapping the scar tissue in the same manner since the tissue in both conditions suppose to be so similar.

Also I remember hearing reports from a few guys in the last round of testing experiencing popping sounds or feelings during erections after they were treated for a little while. So I guess depending on a number of factors its possable. Plaque size, location, erection & or VED strength, etc etc.  

[MikeSmith0]

Thanks for the info...well, that is pretty scary.  They told me that they are doing 2 injections per week + 1 session of "modeling"

Sex and masturbation are to be discontinued for 2 weeks after the injection and modeling.  I guess this would also decrease risk of fracture since it seems like a fracture can only occur in an erect state.   Then there is a 4 week wait, then 2 more injections and more modeling.  

I hope the modeling isn't like a swift "pull" or something... that seems a little scary.

I asked about the snapping noises. They said that the cracking / snapping sound is supposed to be a good thing - since it means the scar tissue is degrading.  Maybe it's the excess collagen plaque separating from the TA or something?    

[Humorous3]

I've completed the first two shots of Cycle 1.  The first one went well.  After the second shot I waited the required hour and, since all was well, left.  Within the next hour my penis started swelling and turning dark red.  Later on it was swollen about 100% and was red to dark red to purple.  I'm not sure what caused it.  However, study participants are warned about "bruising, swelling, and moderate pain".  After two days the swelling was gone.  

About a week after the swelling went away I started modeling and that's very easy, at least in my case.  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.  I was told I could model in the erect state also.  

Humorous

[Humorous3]

Was your erection normal when you had the papaverine?   Levine injected me with that and I had the most bizarre erection which was far from 100% full, and the study excludes people under 30 degrees of curve.  When i am not fully erect, I am under 30 degrees of curve (it worsens as more blood goes in).  And I dont think I can be in the study if I cannot get erect from injected medication.  I'm fine w/ viagra - or even without it - but that injection really burns (to me at least) and is extremely awkward.  

Mike,

My erection with papaverine was about 75-80% of normal (meaning about 20-25% less than usual).  That sounds similar to your experience.  To get into the study you only need to be over 15 degrees of curvature.  I don't think they require a "fully hard" erection or else I might not have been accepted.  In any case they will determine your angle in a scientifically measured way.  From what you've said, it sounds like you would qualify.  

Do you understand their exclusions around sex?  Like, you have to have a regular sex partner... but can you be using viagra every time?  Or, is that exclusionary?  

They require a sex partner later during the study when they expect you to have intercourse.  (At the Cycle 3 visit you will be given a calendar to record this.)  I believe they expect the medicine to take effect during that timeframe.  Concerning using Viagra, I'm guessing they don't mind.  If they do mind, they will inform you when they go over your medication list at the beginning of the study.  

I just noticed that the consent form says they will only treat *one* plaque.  I have a lot more than one... I almost don't think I see the point in going through this (up to 19 visits to the office over 1 year - 4-5 ultrasounds in erect state, etc...) for 1 plaque... do you have more than 1 plaque?

The way it was explained to me, they will treat one area of plaque.  My understanding is most men only have one area where the plaque is "grouped".  For example, I have one plaque which causes a curve of around 55-60 degrees.  Concerning the "4-5 ultrasounds", I can't find where they do any more after the initial qualification visit.  

I hope this helps.  

Humorous

[MikeSmith0]

Hey thanks for letting me know about your experience & answering all of that.   It sounds like you had the typical reaction to any kind of penile injection... with verapamil I had a lot of redness & swelling, etc... not pretty... but usually gone in 5-10 days.  Did they numb you before your shot or did they just put the drug in w/o lidocaine?  With verapamil, they have to numb you bc the needle pokes in & out of the plaque (repeatedly - to weaken it...or so the theory goes)  but it sounds like they just inject xiaflex on top of the plaque & massage it in.

Yeah, papaverine is not the greatest... I wonder if Trimix is better.  To be disqualified for an insufficient curve (due to poor erection) would be frustrating, especially when I can achieve an erection w/ excessive curve at home w/ viagra, etc...

[BrooksBro]

I am now on the potential candidate list for the Phase III study w/ Baylor College of Medicine in Houston.  I won't go through the screening process until the clinic receives it's study medicines.  In reading the inclusion and exclusions, I don't see anything obvious.

[Chopsuey]

Hi everyone,
I haven't posted anything in a while since I pretty much succumbed to the idea that my peyronnies wasn't going to get better. But I also developed "frozen shoulder syndrome" in my right shoulder ealier this year causing me a lot of pain and discomfort. I had to go through months of physicial therapy and in the mean time got addicted to pain meds for a while. I recently read frozen shoulder is related to peyronnies and dupuytren's which I also have a mild case of in my left hand. Anyway, I just got enrolled in the Xiaflex study and received my first injection of what I hope is the drug and not the placebo. I have a double curve, up and to the right. The worst of the curve is 47 degress. No calcifications... I think they don't want you in the study if you have calc, not to make it more successful, but to not have the calcification patients drag the results down. In other words, it would actually make the study less accurate because the drug doesn't have an effect on the calcification like it does on the plaque. By only using patients with 100% plaque, you will see the true effects of the drug. I was told I couldn't be on Viagra, but actually didn't see that in any of the paperwork, so I am not 100% sure that's true. I'm scheduled for my second injection tomorrow at lunch time, then Monday is my first modeling appt. My doc said if I am getting the drug, I will see a difference on my first f/u appt after 6 weeks.

[MikeSmith]

I think they don't want you in the study if you have calc, not to make it more successful, but to not have the calcification patients drag the results down. In other words, it would actually make the study less accurate because the drug doesn't have an effect on the calcification like it does on the plaque. By only using patients with 100% plaque, you will see the true effects of the drug. I was told I couldn't be on Viagra, but actually didn't see that in any of the paperwork, so I am not 100% sure that's true. I'm scheduled for my second injection tomorrow at lunch time, then Monday is my first modeling appt. My doc said if I am getting the drug, I will see a difference on my first f/u appt after 6 weeks.

Interesting info... did he see people in phase 2?  That's interesting he thought you'd see results in 6 weeks... I heard it was more unpredictable than that.

They told me viagra was fine - but no sexual activity 2 weeks post injection...and no viagra the night before the prostaglandin injection.

They let people in with "stippled" calcium (little dots).  If the plaque is 100% calcified, it can't work.  Many scars (even on the skin) have small dots of calcium deposits in them.  You can see them on ultrasound but not an x-ray...they're not really significant contributors to the curve...unless there is a lot.

How did your first shot go ?  Did it hurt or anything?  

Good luck with it.  I can't believe it's 13 mos before you can even find out if you are on the placebo -- but I guess having no results would be one clue.  

[BrooksBro]

The Phase III study information is here:

http://www.clinicaltrials.gov/ct2/show/study/NCT01221597?term=peyronie%27s&rank=1&show_locs=Y#locn


Criteria

Inclusion Criteria

1.Be a male and be ≥ 18 years of age

2.Be in a stable relationship with a female partner/spouse for at least 3 months before screening and be willing to have vaginal intercourse with that partner/spouse

3.Have symptom(s) of Peyronie's disease for at least 12 months before the first dose of study drug and have evidence of stable disease as determined by the investigator

4.Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study

5.Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile

6.Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution

7.Be able to read, complete and understand the various rating instruments in English


Exclusion criteria

1.Has a penile curvature of less than 30° or greater than 90° at the screening visit

2.Has any of the following conditions:

◦Chordee in the presence or absence of hypospadias
◦Thrombosis of the dorsal penile artery and/or vein
◦Infiltration by a benign or malignant mass resulting in penile curvature
◦Infiltration by an infectious agent, such as lymphogranuloma venereum
◦Ventral curvature from any cause
◦Presence of an active sexually transmitted disease
◦Known active hepatitis B or C
◦Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)

3.Has previously undergone surgery for Peyronie's disease

4.Fails to have an erection which in the opinion of the investigator is sufficient to accurately measure the subject's penile deformity after administration of prostaglandin E1 (PGE1) or trimix

5.Has a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray or penile ultrasound that would prevent proper injection of study medication. Non-contiguous stippling of calcium is acceptable for inclusion provided the calcium deposit does not interfere with the injection of AA4500 into the plaque

6.Has an isolated hourglass deformity of the penis

7.Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque

8.Has previously received alternative medical therapies for Peyronie's disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study

9.Has received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E [> 500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti-inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study

10.Has had extracorporeal shock wave therapy (ESWT) for correction of Peyronie's disease within the 6-month period before screening or plans to have ESWT at any time during the study

11.Has used any mechanical type device for correction of Peyronie's disease within the 2-week period before screening or plans to use any these devices at any time during the study

12.Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study

13.Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors

14.Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant

15.Has uncontrolled hypertension, as determined by the investigator

16.Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study

17.Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits

18.Has received an investigational drug or treatment within 30 days before the first dose of study drug

19.Has a known systemic allergy to collagenase or any other excipient of AA4500

20.Has a known allergy to any concomitant medication required as per the protocol

21.Has received anticoagulant medication (except for ≤ 165 mg aspirin daily or ≤ 800 mg of over-the-counter non-steroidal anti-inflammatory drugs [NSAIDS] daily) during the 7 days before each dose of study drug

22.Has received any collagenase treatments within 30 days of the first dose of study drug

23.Has, at any time, received AA4500 for the treatment of Peyronie's disease

[Chopsuey]

Hi everyone,

Had my second injection today and it went well. So far, not adverse reactions to the drug, no swelling and no redness at the injection site. My doctor was able to hit the plaque directly with the needle both yesterday and today. Yes, it hurt both times...especially when he hits plaque. Not unbearable, but you definitely feel it. I go back Monday to learn how to do the modeling correctly and then I don't go back for 6 weeks. Just to reiterate, my doctors says you will see "change" if you received the drug and not the placebo after the first phase. It may not be significant, but he says most guys do see improvement in the first phase. As long as the curve is still greater than 15 degrees, then the injections will continue. The nurse that is part of the study and takes care of the paperwork, monitoring me and drawing up the drug, says she has seen some pretty significant improvement in some guys. I just hope I am getting the drug because it's a lot of needle sticks for getting a placebo. So far I've had 5 sticks and I'm only in phase 1 of 4. I asked my doc and the nurse if there is a risk of the needle sticks making it worse and they said no. I'll let you know how things go.

[MikeSmith0]

Hi everyone,

Had my second injection today and it went well. So far, not adverse reactions to the drug, no swelling and no redness at the injection site. My doctor was able to hit the plaque directly with the needle both yesterday and today. Yes, it hurt both times...especially when he hits plaque. Not unbearable, but you definitely feel it.

Same with me... I don't think we had the real drug.  I think the swelling and pain would be a lot worse.  I started a thread for all guys involved in this to talk about it.

[jaima]

 I am a 62 years old healthy guy married to a young lady 15 years younger than me , was diagnosed the decease a year ago and has being
a bloody nightmare, my SEx life has gone to hell, wander if somebody could give me a tip how to cope with this tragedy, may penny is
got shorten about half the size is used to be and lumpy, there is any Pill to take or some other physical extender that work?
very much appreciated
Jaime

[GS]

jaima,

There is no magic pill for peyronies, but there are a lot of things that can help you.  All of them are talked about in detail on this website and our forum.  You will just need to spend the time to explore the website and you will get a lot of good information.

I have had Peyronies for over 2 years now and thanks to this website and the information I gathered here, I am now pain free and have regained some of my lost size.

It takes time and effort, but you can improve your situation.  Good luck.

GS

[restore]

I read somewhere that if trial tests of Xiaflex prove that it does indeed dissolve the plaque (or scar tissue), that still will not restore the elastin that should be there.  So, if after Xiaflex success is  shown, would one's penis still expand in an unnatural or abnormal way?

I am hopeful that if the drug does work, that it would not only rid us of our scars, but also bring back the healthy tissue that is supposed to be there.  Literally, a restoration of our penises before Peyronies.  Any thoughts on this?  

[Ben]

This article makes sense to me. Fibrous tissue is dead penile muscular tissue. So Xiaflex may bring healthy lasting tissue to their maximum expansion but may not restore prior condition.
According to my knwoledge only stretching can create new cells. So it could be a good combo.
Xiaflex may enhance erectile function by dissolving plaque which compress dorsal nerve (frequent in peyronie's case).
I have to report some good improvement with bathmate (water ved) and traction (700 hrs yet). More girth stronger erection, more lenght, less curvature. Stretching is sometimes boring but really worth it.

[MikeSmith0]

I asked my doctor about this in my last visit.  He said the plaques have bundles of distorted collagen and elastin fibers together...and the main issue that causes the curve is not really a loss of elastin in the TA but the hard collagen fibers that won't let the TA expand.  Also, I think he implied that once xiaflex dissolves the collagen it will allow the body to clear out the elastin that is also damaged - and then ultimately rebuild new tissue - but this doesn't happen overnight - maybe 2-3 years or more to go thru the full healing cycle.  So, the makers of xiaflex and the uros involved in the study seem to feel that it will help the curve.  However, he seemed less optimistic about restoring size, thus making the point about elastin a viable one.  Xiaflex may help "visible" length by getting rid of the bend but it would be surprising if it helped "true" length - or girth.  I think xiaflex is a 50% solution but that's still good because a 100% solution is nearly impossible.  Anyone who figures out how to regenerate elastin would be a billionaire... just think of all the skincare creams that claim to do this (but none can really do it).

[ComeBacKid]

MikeSmith,

Very interesting, so it sounds like the tissue can regenerate or come back to some degree, there is definately a future in this kind of medicine and tissue research for sure.  

Ben,

Your absolutely right in that the stretching with the VED or other device is boring as hell but definately worth it, its a slow tedious process like healing a bone with a cast, but definately does work and is not a fluke!  Some tissue that is harder will take longer, after about 6 months you will notice benefits for sure.

Comebackid

[BSSS]

In my last post I indicated I'd be starting the trial shortly, but I wasn't able to make the appt due to illness.  I do plan to contact the office again, but am not sure I'll stil be eligible there.

Will update when I know more.

To the guys involved in the study keeping us posted, thank you!

BSSS  

[BrooksBro]

When I agreed to be on the potential candidate list for the Phase 3 study, I had mixed thoughts about it.  Mostly I was concerned about the possibility of getting stuck repeatedly with the placebo.  Some of the exclusionary criteria - no use of traction or VED for the duration - was also unappealing.  When the doc (Larry Lipshultz, Baylor Urology Clinic, Houston) called for the initial screening, I learned they do not want candidates who have taken pentoxifylline within 90-days of the first injection.  I do not remember seeing this in the FDA's Xiaflex study information, but it may have been there.  They are beginning their study in February, which excludes me out of this round.  I suppose it is possible they may not get enough of their ideal candidates, and slight revise their selection criteria or dates.

[restore]

I know hourglassing is excluded in the candidates for this study, but I hope that doesn't mean the drug won't be prescribed for those of us who have that deformity later on.

[bummedout]

I hope so too.  Xiaflex is really my only hope at this point.  I'm almost completely dysfunctional, mainly because of this "venous leakage".  I have hourglassing at the base and bottlenecking at the tip of my penis.  I have used a VED in the past, but stopped because I felt as if it was making things worse.  It was also just a really awkward thing to do, and I didn't have the time for it.  If I knew it definitely worked and that after a certain point I wouldn't have to use it anymore I would continue, but there are just too many uncertainties.  I haven't posted in a while, but I'm stuck inside because of a snow storm so I guess now is as good of a time as any.  I'm 31, and have been living with this for 3 years now. I have not been able to have a meaningful relationship with a woman in that time.  Clinging to hope.

Bummed

[crashbandit]

I hope so too.  Xiaflex is really my only hope at this point.  I'm almost completely dysfunctional, mainly because of this "venous leakage".  I have hourglassing at the base and bottlenecking at the tip of my penis.  I have used a VED in the past, but stopped because I felt as if it was making things worse.  It was also just a really awkward thing to do, and I didn't have the time for it.  If I knew it definitely worked and that after a certain point I wouldn't have to use it anymore I would continue, but there are just too many uncertainties.  I haven't posted in a while, but I'm stuck inside because of a snow storm so I guess now is as good of a time as any.  I'm 31, and have been living with this for 3 years now. I have not been able to have a meaningful relationship with a woman in that time.  Clinging to hope.

Bummed

That sounds pretty crappy bummed... I think you should just go and get some sex no matter what it takes. Just get the mister some touch could possibly pull you out of your funk. Pay for it, settle for it, do whatever you gotta do, just get some ass. Sorry if that sounds rude and offensive but I think it could really help you get things moving in the right way.

[bummedout]

Yeah, we'll see.  It's all about survival right now.

[LWillisjr]

bummedout......
You state that Xiaflex is you only option. Have you seen a specialist and discussed with them any other options?

[fubar]

Bummed
There are always options and there is what the future holds.I do not recommend having sex with a weak penis.You are not the only one on the forum that his this problem as I suspect I do do to. Sometimes they are strong other times they are weak.No cowboy stuff for sure as someone coming down or move you in angles and push against  the hour glassing and break you at eigther side causing more trauma and scarring.
If you are consideing a partner I would take controll of the sex so nothing would harm me.

Be safe and protect yourself but find pleasing the other important.So you can come out of the experience in in a good and successful way.Respecting the other and yourself and having a great experience.

Take safe care and action in what you do respect others and yourself!


PS: I do not think xiaflex is a remedy,  maybe a step forward as men in science may want to contribute for of fearing this may happen to them.Hard to care if you are not inflicted? Right?



Fubar

[restore]

The urologist I'm seeing now told me he believes that Xiaflex really will be the most significant thing that is going to work for the majority of men.  However, he said he couldn't get me in the study since I have just acquired Peyronies and am in the early acute phase.  He said my plaque is also in a difficult area to target it.  Not sure if that will change but hope so.  I really feel optimistic that there will be a cure eventually.  Dont like it when I read other doctors say it is incurable such as on menshealthpd.com website forum.  I think it's more accurate to say that no cure exists right now.  

[ComeBacKid]

Restore,

I agree, while I'm skeptical of just about everything I hear and investigate it the best I can, I think some are being to negative with this drug.  I think each case of peyronies is different and unique and this drug may work very well for some, while not working well for others, only time will tell really, we all just need to be patient.  As we move into the new year and the final phase of trials for this drug( I feel like I've said this three times already) we should get some solid conclusions by the end of spring I'd hope... Does anyone know when this next phase of trials is set to be done with a final study out on it?

Comebackid

[BrooksBro]

Does anyone know when this next phase of trials is set to be done with a final study out on it?

From the study, March 2012 - more than one year from now.

http://www.clinicaltrials.gov/ct2/show/study/NCT01221597?term=peyronie%27s&rank=1&show_locs=Y#locn

Estimated Enrollment: 300
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

[MikeSmith0]

Bummed,

You've got some opportunity now if you are in the acute phase.  Try to use the traction or VED devices... take pentoxifiline to inhibit TGFb1 (inflammatory agent present in Peyronies Disease - but rarely in normal anatomy).  Get cialis or viagra to get blood flow in there regularly...maintain the size.  I wish I had done MORE during the accute phase to avoid losing as much size as i did.  I thought the verapimil injections were going to be the way to cure this in the early acute phase, but i was totally wrong about that.  The other things have worked for me though...so try this stuff.  If you were in the xiaflex trial, you wouldn't be allowed to do any of it - by the way... no traction, pentox, etc... cuz they need to control the study.  So give this stuff a shot if you can.  It's gonna be a long time for xiaflex to hit the open market... you can do a lot of things in the meantime.  I haven't read any of your other posts so sorry if i am replying uninformed about your situation.

[ComeBacKid]

Wow March 2012 is disappointing.  I remember some on here saying that once it gets FDA approved doctors will start offering it, or even sooner, wonder what happened to those people?

Comebackid

[MikeSmith0]

Not to make it worse...but  that's just when the study is done... Then it gets in line at the FDA... then insurance companies have to catch up with payment (early dupuytren's patients using xiaflex were declined payment but auxillium is apparently working with the insurers who were not sure what to make out of a 3k injection vs surgery).  So, anyway I think people should do all they can in the meantime who are not in the study.  If I am getting the placebo - they supposedly will open it up to us first (the 100 of us who will have had 20 penile injections over a year period & 17 visits to the urologist, yay for us).  However, if the drug shows side effects or is not effective - or auxillium has financial problems or anything else happens - then that promise will be scrapped most likely.  We'll see.  The placebo guys will probably be treated in the march - may time frame (2012).  

[ComeBacKid]

Mike,

Thats not extremely encouraging, thats a good bit of time to go still.  Do you see it being used on peyronies now that it is approved for DC?  This would be off label usage, I wonder if any top notch docs will try it or wait for the complete study from Auxilium, that might be a good question for your doctor.  Thanks for keeping us updated, its good to hear whats going on with this study!

Comebackid

[BrooksBro]

In my opinion, most of top peyronies urology specialists in the U.S. are the one's participating in this study.  I counted 28 in 21 states, plus 5 in Australia.

[MikeSmith0]

Mike,

Thats not extremely encouraging, thats a good bit of time to go still.  Do you see it being used on peyronies now that it is approved for DC?  This would be off label usage, I wonder if any top notch docs will try it or wait for the complete study from Auxilium, that might be a good question for your doctor.  Thanks for keeping us updated, its good to hear whats going on with this study!

Comebackid

I asked about this... they can't do it because of a few reasons... First, Auxillium won't sell the product to anyone except hand surgeons (orthopedic surgeons).  It's being extremely controlled bc they don't want people using it off label & then running into problems and killing the FDA approval process or the physician acceptance process (which in some ways is just as important as FDA approval).   Second, insurance will not reimburse this for off-label use.  It would be billed as a "procedure" - rather than something you pick up at the drugstore...so, though it's easy to get off label drugs reimbursed at the drug store (e.g. pentox is not FDA approved for Peyronies Disease) you can't get off label injections like this reimbursed -- especially since the shot is between 3-4k and I think you might need up to 8 of them.  Third, Auxillium has not made the details of the dilution process for Peyronies Disease public as far as I know.  Specifically, Xiaflex comes in a powder that has to be reconstituted in a very very specific way.  For DC, I suspect the dose is much higher to dissolve the cord.  In Peyronies Disease, it probably has to be lower given where they are putting it.   It's complicated as hell - and results are still unknown though they were positive in phase 2.  I'll post how it's going for me when I have something to report.  

[ComeBacKid]

Mike,

Hmm Sounds like they are really controlling this drug, probably worried about liabilities that someone didn't think of yet as well.  You asked sound questions, yes definately keep us updated!

Comebackid