Developmental drugs & treatments - Still in trial or not approved for Peyronies

[George999]

The problem I see with this approach is that it simply has to have significant negative side effects.  The immune system produces TGF-beta1 for a reason.  When you snuff out that metabolic function, there are bound to be negative consequences.  - George

[ocelot556]

Saw this link in my random clinical trial searching... maybe it's been reported, maybe not - but it looks interesting! Arresting Suspect #1 in the inflammation cascade - TGF-Beta.

http://www.medpedia.com/clinical-trials/NCT00043706

"Excess Transforming Growth Factor Beta-1 (TGF-beta1) activity may result in the abnormal fibrosis characteristic of Systemic Sclerosis. An antibody against TGF-beta1 may modify pathologic processes characterized by inappropriate fibrosis. Genzyme Corporation is currently investigating a human monoclonal antibody (CAT-192) that neutralizes active TGF-beta1. This study is being conducted in the U.S. and Europe to evaluate the safety, tolerability, and pharmacokinetics of repeated treatments with CAT-192 in patients with early stage diffuse Systemic Sclerosis."

[percival]

Further to my earlier post I have tried applying a thermal heat patch to the affected area. It seems to stay in place in my underpants and gives out a gentle heat all day - it is rather pleasant. Don't know if it will do any good though! I am also trying Pentox, Arginine and daily Cialis. Also trying traction: first results after a month are encouraging. I think that the plaque had bunched up and the traction has pulled it straight and given back a little length.
One word of warning concerning thermal patches - there are many on the market so check that they don't get too hot. You may need to wrap them in a sock to moderate the output.
Warm regards
Percival

[percival]

Back to the subject of heat treatment, I have always thought that there may be a temperature trigger which may cause or promote Peyronies Disease. Testicles are situated outside the body because a lower temperature favours sperm production. The penis is in a similar - even more 'exposed' environment, so could it be that the lower temperature it experiences causes plaque to form there when certain other factors are present.
I would certainly try heat treatment, but I don't know of any (safe) gadgets available for localised application.
Regards
Percival

[sunny sky]

Thanks for the heads-up on this research.  I am going to Email some of these links to urologists in my region so they can get us involved in these studies.

[mischelstraus]

thanks to all people for sharing and advice me very informative info.
keep sharing in future also.

[newguy]

Full article here

http://news.bbc.co.uk/1/hi/health/8263307.stm

Very interesting. It reminds me of topical ibuprofen where the topical version provides a similiar level of relief, but very little of it circulates beyond that area.  In studies where viagra has helped to inhibit fibrosis in rats, much higher doses than we are able to take were used. If in future it can be intensely targetted in such a way, maybe it will be much more effective. 

[UK]

this is interesting and could provide an option for getting medication into the tunica one day for you younger sufferers


"A cream allowing erectile dysfunction drugs to be applied directly to the skin could one day make them safer to use, say New York scientists. Studies in rats suggest that Viagra, Levitra and Cialis could pass through the skin in tiny capsules, they say."

Full article here

http://news.bbc.co.uk/1/hi/health/8263307.stm

[newguy]

A IN-1130 study here includes an email address from a college of pharmacy should anybody wish to attempt to follow this one up:

http://www.informahealthcare.com/doi/abs/10.1080/00498250701871121

College of Pharmacy, Ewha Womans University, 11-1 Daehyun-dong, Seodaemun-ku, Seoul 120-750, Korea, 82-2-3277-3028, 82-2-3277-3051 yysheen@ewha.ac.kr

[ComeBacKid]

Why was this study being done in korea?  Aren't there more studies going on in the united states or a bigger country with more doctors?

Could one obtain this drug for usage? Is it as safe as pentox, what do we know about it , or should I say what do the medical experts know about it, how safe is it?

The real question I have is what if one used this drug and it was effective, for a complete reversal of peyronies, then quit using it, would the peyronies come back?  Perhaps a few months on it could outweigh the risk of getting diseases if it works and we know it works. 

[George999]

I really think that what we learn through the IN-1130 study is that if one can block or stop TGF-beta1 effectively enough, one can REVERSE Peyronie's effectively returning penile tissue to NORMAL.  That would be a HUGE achievement which everyone here would cheer.  It indicates that the reason Pentox is so ineffective is because it simply does not block TGF-beta1 sufficiently to effect an outright reversal.  It does block it enough to thwart its progress and initiate a feeble reversal.  ALL of this is more evidence for autoimmune processes being the driving force behind Peyronie's.  Remove that factor and everything goes back to normal.  So what are the flies in the ointment for IN-1130?  I see some big ones.  First of all, TGF-beta1 is an essential cytokine which has a lot of legitimate immune functions.  If we block it completely, we could run into unexpected consequences like cancer or vulnerability to infectious disease.  In order to avoid those pitfalls, one has to specifically block ONLY the autoimmune pathways while allowing normal immune pathways to remain functional.  I really don't know whether IN-1130 is a SELECTIVE TGF-beta1 blocker or a brute force broad spectrum blocker.  A broad spectrum blockade would be scary to me.  - George

[bodoo2u]

Regarding your remark, in your most recent statement below, on how well the treatment might work for humans, do we need to consider that a mouse's life is much shorter than a human's and therefore calculate the time accordingly. Do you, or anyone else on the forum, know what 45 mouse days is in human days, or years?

[newguy]

Advanced glycation end products (AGEs) contribute significantly to diabetic complications, both macro- and microvascular. TRC4186 is an AGE-breaker that has been evaluated in vitro and in vivo and shown to reduce AGE burden. The aim of this study was to determine the effect of TRC4186 on diabetic cardiomyopathy and nephropathy in obese Zucker spontaneously hypertensive fatty rats (Ob-ZSF1), an animal model of diabetes with progressive cardiac and renal dysfunction. Ob-ZSF1 rats loaded with 0.5% salt were treated with TRC4186, 9 or 27 mg/kg twice daily intraperitoneally or vehicle control and monitored telemetrically throughout the study. Cardiac function was assessed terminally by Millar catheter. Markers of cardiac and renal dysfunction were measured and changes evaluated histopathologically. TRC4186 at 27 mg/kg prevented rise in blood pressure (BP) and also improved cardiac output (CO) secondary to better diastolic relaxation as well as systolic emptying in association with the reduction in afterload. At 9 mg/kg, CO was improved by compensatory increase in pre-load however afterload reduction was not adequate to allow efficient systolic emptying. Brain natriuretic peptide (BNP) and interleukin-6 (IL-6) expression was reduced with treatment. Deterioration in renal function was retarded as evident from albumin to creatinine ratio and renal histopathology. TRC4186, an AGE-breaker, clearly preserved cardiac function and reduced the severity of renal dysfunction in Ob-ZSF1, an animal model with persistent severe hyperglycemia leading to diabetic heart failure and renal failure.

- http://www.ncbi.nlm.nih.gov/pubmed/19546815?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

Another AGE-breaker working its way through the system..

[newguy]

It was posted a while back: http://www.peyroniesforum.net/index.php/topic,36.msg20393/topicseen.html#msg20393  Certainly looks like something of interest.

[slowandsteady]

Nice find -- thanks.

Antagonizing TGF-beta signaling through the use of ALK5 inhibitors may represent an exciting new therapeutic strategy for the future treatment of Peyronies Disease.

Leads me to wonder what other ALK5 inhibitors are out there. The study cited used IN-1130.

[Tim468]

I missed that one (I follow for any publication that uses "Peyronie's Disease" as a key term having the medical library scan for it weekly).

It is very exciting news. The issue I wonder about is this: are there multiple forms of Peyronies that have different inciting events and pathways to fibrosis. This blocks it (and more excitingly - it causes regression!) in a rat model of disease. I wonder how it might work for you or me.

Tim

[roadblock]

Forgive me if this was already posted...looks like its from May of this year...

http://www.ncbi.nlm.nih.gov/pubmed/19473283?ordinalpos=9&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

[newguy]

CF - I think numbers here is all we have so far: http://www.auxilium.com/ProductPipeline/PeyroniesDisease.aspx It's very limited but at least it suggests that they are fine tuning their technique.

[cowboyfood]

The early clinical trial results for peyronie's revealed  . . .

newguy,

thanks for the response.  do you have a link or a document with these "early clinical trial results?"  Or, maybe it's already posted somewhere on the forum.

CF

[newguy]

J - Yes, I read a few stories about how surgery doesn't always go to plan, and can occasionally result in nerve damage etc. I suppose it's something worth catching early to maximise (the limited) treatment options. Radiation therapy appears to be all the rage on the dupuytrens forum for early stage intervention.

[j]

Strictly speaking the effectivness of the dupuytren's trials are as probably as much to do with the nature of the condition (that once the the scar tissue is sufficiently weakened it can be totally released from the underlying tissue)...

That's partially true. Dupuytren's contractures may or may not be strongly adhered to the surrounding tissue.  When there is a lot of adhesion the contracture can only be released by surgery, and that may be only partially successfull.  Contractures in the palm tend to have much less adhesion, and be easier to release by 'snapping', than contractures further out in the fingers.

[newguy]

Hi cowboyfood. My comments are based on the reduction of most of the joint contractures in dupuytren's patients to between 0-5 degrees. The early clinical trial results for peyronie's revealed a 25%+ reduction in curvature. It may be the case that some of those improvements were very significant, or that the technique can to has been refined to maximise the potential of xiaflex, so I would not wish for anybody to be disillusioned. Should the treatment become available to us all at some stage, and ill effects or complications are minimal, maybe it will be possible to successfully combine it with other treatments or have further injections. I'm as much in the dark as anybody really and hope that future announcements from auxilium.com are promosing.

Strictly speaking the effectivness of the dupuytren's trials are as probably as much to do with the nature of the condition (that once the the scar tissue is sufficiently weakened it can be totally released from the underlying tissue), which differs from that of peyronie's disease. Again, Xiaflex may potentially offer an almost instant reduction in curvature for many individuals, so I don't want to put a downer on it. It's certainly a treatment of interest.

Thanks for your posts too . I really don't mind people disagreeing with what I write, as its healthy to have ideas challanged and to be corrected if I make statements that cannot be 100% backed up.

[cowboyfood]

That being the case the peyronie's results with xiaflex are of course not as impressive, but this study interesting none the less.

Newguy,

with all due respect (you're one of my favorite posters), your statement (see above, emphasis supplied by me) is conclusionary and is not supported by any cited sources.

I believe you may be referring to a conference call provided to primarily the investment community, and if I recall, the company did not publicly reach the conclusion that you have.  Or, even less authoritative, posters alleging to have participated in the trials.

Another point (and, I may be way off base here), regarding drug research on trial participants, the actual participant results that "we" may conclude are not "impressive" may in fact be of invaluable information to the researchers.  Meaning, the results provide them with information that they can use to "optimize" the drugs use.

So, although I appreciate your interest in the Xiaflex trials, I cannot agree with your above statement and it may cause other readers to become disillusioned.

thanks for all your efforts!

CF

[newguy]

ComebackKid - I was refering to the info out there thus far, and not any new results. I look forward to us receiving any updates relating to how effective this treatment actually is.

[ComeBacKid]

That being the case the peyronie's results with xiaflex are of course not as impressive, but this study interesting none the less

Newguy, what peyronies results with xiaflex are you referring to, I thought that auxilium has not published any results yet unless I missed something?  

[newguy]

Injectable Collagenase Clostridium Histolyticum for Dupuytren's Contracture

Methods We enrolled 308 patients with joint contractures of 20 degrees or more in this prospective, randomized, double-blind, placebo-controlled, multicenter trial. The primary metacarpophalangeal or proximal interphalangeal joints of these patients were randomly assigned to receive up to three injections of collagenase clostridium histolyticum (at a dose of 0.58 mg per injection) or placebo in the contracted collagen cord at 30-day intervals. One day after injection, the joints were manipulated. The primary end point was a reduction in contracture to 0 to 5 degrees of full extension 30 days after the last injection. Twenty-six secondary end points were evaluated, and data on adverse events were collected.

Results Collagenase treatment significantly improved outcomes. More cords that were injected with collagenase than cords injected with placebo met the primary end point (64.0% vs. 6.8%, P<0.001), as well as all secondary end points (P0.002). Overall, the range of motion in the joints was significantly improved after injection with collagenase as compared with placebo (from 43.9 to 80.7 degrees vs. from 45.3 to 49.5 degrees, P<0.001). The most commonly reported adverse events were localized swelling, pain, bruising, pruritus, and transient regional lymph-node enlargement and tenderness. Three treatment-related serious adverse events were reported: two tendon ruptures and one case of complex regional pain syndrome. No significant changes in flexion or grip strength, no systemic allergic reactions, and no nerve injuries were observed.

Conclusions Collagenase clostridium histolyticum significantly reduced contractures and improved the range of motion in joints affected by advanced Dupuytren's disease. - http://nejm.highwire.org/cgi/content/abstract/361/10/968

Of course peyronie's only has a limited amount of common with Dupuytren's (it would probably be unwise to attempt to manipulate the penis in the same way you'd manipulate a joint - other than by light traction) . That being the case the peyronie's results with xiaflex are of course not as impressive, but this study interesting none the less.

[ComeBacKid]

Hey guys,

Saw this in the usa today, just found it interesting since we know phizer bought auxilium out and the right to market their drugs.

Phizer gets fined big time!

Wow, thats a heck of a fine to pay, I wonder if that will negatively effect the company's ability to market or develop future drugs like xiaflex?

I was reading up on off-label usage, I did not know it is legal to prescribe medications for off-label usage, but illegal to market them.  So really anyone in this forum who is taking pentox for peyronies is using an drug for an "off-label" purpose.

Off-label use is the practice of prescribing pharmaceuticals for a purpose outside the scope of a drug's approved label - an unproven, untested use - most often concerning the drug's indication[citation needed]. In the United States, the Food and Drug Administration (FDA) requires numerous clinical trials to prove a drug's safety and efficacy in treating a given disease or condition[citation needed]. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drug's label. More detail is included in the drug's package insert.

However, once the FDA approves a drug for prescription use, they do not attempt to regulate the usage of the medicine, and so the physician makes decisions based on her or his best judgment. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates. Actiq, for example, is commonly prescribed off-label even though it is a Schedule II controlled substance. However, it is unlawful to market, advertise or otherwise promote the off-label use of drugs, including controlled substances.

Off-label use of medications is very common. Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31% (Radley, et al. 2006).[1] New drugs are often not tested for safety and efficacy specifically in children. Therefore, it is believed that 50-75% of all medications prescribed by pediatricians in the U.S. are for off-label applications.[2]

Some drugs are used more frequently off-label than for their original, FDA-approved indications. A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off-label, and more than half of cancer patients received at least one drug for an off-label indication. A 1997 survey of 200 cancer doctors by the American Enterprise Institute and the American Cancer Society found that 60% of them prescribed drugs off-label. [3]. Frequently, the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressants to treat neuropathic pain. This old class of antidepressants is now rarely used for clinical depression due to side effects, but the tricyclics are often effective for treating pain.

Off-label  use

[j]

I'm not much into conspiracy theories.  I'd just say that surgeons seem to be very conservative and not open to new ideas unless they come down from above, through the usual channels.  Surgeons want to do surgery - it's what they know.   Some, maybe most, of them also want the best deal for their patients. 

The surgeons probably know how complex and variable the human anatomy really is - they see it from the inside - and they don't like the idea of some Beverly Hills MD adding to his Botox income by injecting Xiaflex and letting the lawyers deal with the mistakes. But in my experience, surgeons minimize the risks and downside of their own procedures.

Reading this article, I can see how urologists might be cautious about getting into this treatment. 

[ComeBacKid]

J,

It could be possible doctors would resist a solution, as then they couldn't do surgeries and make $$$, since they get paid significant money based on procedures.  However they'd have to be in bed with Auxillium wouldn't they?  Wouldn't auxillium purposely have to be sabatoging their own product  in xiaflex?

Comebackid

[j]

In the Dupuytren's trials, they had a couple cases of tendon damage:
  http://tinyurl.com/mh95ux

The article at that link includes comments from a couple of hand surgeons who in my opinion are overly negative.  I've had Dupuytren's surgery - it's rough, damage can happen (I had a nerve severed),  recovery is long, infection is possible, scar tissue builds up - and surgeons tend to minimize all these risks.   Many people feel that hand surgeons simply don't want to lose the income from Dupuytren's sugeries.  I won't go that far, but I think they're instinctively resisting a non-surgical alternative.  The surgeons quoted in this article do make a good point, which is that injecting Xiaflex requires a detailed knowledge of the target anatomy.

Xiaflex is potent stuff, biologically active - unlike all the snake oil we've been sold in the past - so some issues are to be expected.

[ComeBacKid]

I just talked with a doctor friend of mine in regards to these trials.  He stated to me that the FDA is more concerned with safety as J has already stated.  They are probably overly concerned about this in my friends opinion, however they due it to protect potential patients.  They are less concerned about effectiveness, once they get the clearness I think as J states there will be a much more aggressive treatment protocol.  Really it could be many things.  I'm looking forward to seeing some ultra sound evidence that the drug can really dissolve the peyronies plaque or tissue or modify it.  VED could be used to help stretch the tissue if it is only made to be more flexible but not completely dissolved. 

J is right in that this forum can have an impact on what this forum does.  It is extremely important that we continue to work hard to grow our membership, as we are doing in the advocacy section of our forum, anyone who is interested come take a look, we are working on a  mass mailing project to urologists to recruit more peyronies sufferers.  We need to grow our membership, and at some point write a letter to Auxillium or leading urologists who have pull.  J is absolutely right in that it is important once Auxillium gets the FDA safety clearance, they don't stop working on the effectiveness of this drug, otherwise we may not get the full cure we are looking and praying for here.

Comebackid

[j]

Maybe more injections over a wider area; maybe in combination with a stretching device or VED;  maybe several treatments over a period of time.   I don't want to speculate too much further because I'm not a doctor.   

With Dupuytren's the corrective treatment can get pretty rough. With Peyronie's, a more sophisticated approach will be required.

[skunkworks]

Hmm so would you say that the treatment should involve an injection of xiaflex and then something to give and maintain an erection for awhile, so the xiaflex weakens the fibrotic tissue and the erection remodels the shape?

[j]

The treatment probably wasn't agressive enough. 

For Dupuytren's they injected Xiaflex, let it work for a while to weaken the tissue, then tried to forcibly straighten the finger and snap the cord.  And I mean "forcibly".  The injection of Xiaflex on its own wasn't powerful enough to simply dissolve the cord and release the finger. They're afraid that if they injected enough Xiaflex to do the job on its own, there'd be collateral damage to surrounding "good" tissue.

With Peyronie's they're dealing with a more delicate structure and so I think they were even more conservative. As a result they didn't break up enough tissue, in most cases, to cause a truly useful change. 

This was probably not a surprise to Auxilium. To get FDA approval you need to show complete safety but only very modest positive effect.  This is why we often end up with widely prescribed big-name drugs that really aren't very effective, and sometimes long term followup studies show that they're a waste of money.  Once FDA approval is secured, a drug company may stop spending money on additional research and just pour it into massive advertising campaigns.  I hope that doesn't happen here, and that Auxilium works on improving the effectiveness of Xiaflex treatment. 

This forum can have a real impact on what Auxilium decides to do. 

[ohjb1]

Newguy - don't know anything more about other men other than what I read on this forum. One member contacted my privately and also said no change in his condition after the trial.  Whether i received Xiaflex or placebo, really don't know. Some forum members believe that if there was bruising they recevied the real thing. My urologist said this is not the case as the insertion of the needle into the plaque results in bruising.  Basically, we are in the dark until the results of published. 

[newguy]

Are you aware of many other men is the study and how their condition fared after the treatment? Are you under the impression that you received a placebo, or xiaflex? Of course it's of limited use to discuss these things when compared to the released results, but it's of interest to speak to someone who went through the process.

[ohjb1]

Thanks for your reply. Just a few follow up comments. I was in the phase IIb trial and was in the modeling group. Secondly, everyone in phase 11b who received Xiaflex as opposed to the placebo received the same dosing as those in the previous trial who reported 8 out of 9 participants who improved. Of course, we do not know who received the placebo and we are speculating.  FYI - There has been no change in my condition.

[newguy]

ohjb1 -

They are somewhat limited as to what they feel comfortable in stating. The previous results (in study A) revealed that a 25% reduction in curvature "was achieved at three and six months with 58% and 53% of patients, respectively". This to me is not exactly a resounding success, and surely the three and six month differences actually mean that some mens curvature initially improved, but then increased somewhat between that period (from the point of improvement, not the starting point - i don't want to scare people ).

Not to put a total downer of it though, as it very much appear that the treatment program does play a large part in the success or otherwise of the treatment. Study B which effectively involved receiving more injections resulted in 25%+ improvement in 8 out of 9 patients. I'm unsure of whether modeling (via a traction device I assume?) was used in these phase IIb trials, though it was used in phase IIa. The comment regard it from Auxillium, well I couldn't quite figure out how it applied to the latest trials:

"The other piece that we are testing is whether or not modeling works or doesn’t work. One of the studies had modeling, the other one didn’t. The one that had modeling in the previous IIa had somewhat higher and a more sustained effect, but we are testing that at this particular point in the trial."

Auxilium did note that " the FDA, in our discussions with them prior to the initiation of this trial, really encouraged us to go down the pathway of developing the patient reported outcomes, because they believe that a greater than 25% reduction in angle, if it doesn’t translate into meaningful improvement in sexual activity, reduction in pain, and some of the other domains, probably isn’t a valid objective endpoint.". This suggests that there are doubts over whether a 25%+ improvement is enough to make this worthwhile. Hopefully they will decide that it is worthwhile.

Phase 3 trials could be happening next year. If the improvement was, say 50% I think that would be reason to be really happy about all of this. If it does make it to markey though, use of Xiaflex in combination with other treatments could still make the difference to an awful lot of men. Time will tell how this pans out.

[ohjb1]

There is a recent interview with Auxillium executives and I don't see much in the way of a discussion about a decrease in curvature due to Xiaflex.  Hope I am wrong, but this may be a bad sign.

http://seekingalpha.com/article/135832-auxilium-pharmaceuticals-inc-q1-2009-earnings-call-transcript?source=yahoo&page=10

[newguy]

"In fact, the self-alleged trial participants have to speculate themselves as to whether they even received Xiaflex as opposed to the placebo!"

Yes, that's very true. I guess we have to play a waiting game for now.

I notice that phase 3 trials for Xiaflex for Dupuytren's have resumed:  http://www.medicalnewstoday.com/articles/79922.php

[cowboyfood]

Any new updates from those previously enrolled in the Xiaflex trials? We had something of a mixed bag before, with some people claiming improvement, or one that I can remember stating that his condition actually worsened.

newguy,

I too appreciated the fact that some men took the time to post about their experience.

However, I'm infinitely more interested in the company's actual report than anecdotal stories from those claiming to be a part of the trial.  This is because many members will engage in mere speculation on the treatment's potential based on a forum post.  In fact, the self-alleged trial participants have to speculate themselves as to whether they even received Xiaflex as opposed to the placebo!

CF

[newguy]

Any new updates from those previously enrolled in the Xiaflex trials? We had something of a mixed bag before, with some people claiming improvement, or one that I can remember stating that his condition actually worsened.

My thoughts are:

- I wonder if the follow up they perform is sufficient. It's not beyond the realms of possibility that men could experience negative changes outside of the obervation period.

- As moderate brusing and swelling appear to have occured with some men (men prone to penile injuries escalating), maybe this can inhibit some potential improvement. Hopefully in combination with other treatments (oral, mechanical), this negative could be lessened. It stands to reason that getting on a good oral treatment routine early on in the peyronies lifecycle is useful, thus it would probably be a good idea for those undergoing xiaflex injections to do this too as a precaution. I suppose that's out of the question during the initial trials, but in the long run, it would make sense.

[androman]

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[newguy]

Research on ways to prevent Peyronie's by intervening in the "inflammatory phase" seems unproductive to me because no one seeks treatment at that point.

I'm more interested in the efforts of those trying out new strategies and oral treatment combinations to attempt to give hope to peyronie's sufferers. This all sounds a bit doom and gloom to me. If people are not seeking treatment during the inflamatory stage, then we should enlighten them to the possibility of doing so, rather than assume that little can be done to help the situation. Doing something is always better than doing nothing.

It seems likely to me that the most promising future treatments may well relate to altering the immune resource to inflammation as soon as humanly possible, which is why it's worth exploring options like Low Dose Naltrexone. There is no way of knowing when a breakthrough will come, but with a proactive approach there is hope that we will stumble upon something.  This in combination with treatments that are somewhat helpful (VED and so on), is a sensible approach to a difficult problem.  What's the alternative?

Dupuytren's also causes inflammation early on, which was the reason for trying NSAIDs and antiistamines.  I believe no one ever demonstrated success in stopping the eventual progression of the fibrosis, but that might be because no one tried hard enough.

Used early on, radiation therapy appeared to be somewhat successful. I haven't checked out studies but on the forum there, people seem to be pleased with the results, so something positive appears to be happening: http://www.dupuytren-online.info/radiation_therapy.html  I'm not suggesting this as a treatment for peyronie's, but rather trying to push the idea that we need to muster the motivation to really go all out looking for new treatment strategies, and maintain hope for others even if our own situation isn't great in all cases.

[j]

Dupuytren's also causes inflammation early on, which was the reason for trying NSAIDs and antiistamines.  I believe no one ever demonstrated success in stopping the eventual progression of the fibrosis, but that might be because no one tried hard enough.  To me though these "inflammatory phase" ideas remind me of all the things that are supposed to cure a cold if taken at the very earliest stage - i.e. by the time you're sure you have a cold, it's too late, they only "work" when there's a 50% chance you don't even have one.

Research on ways to prevent Peyronie's by intervening in the "inflammatory phase" seems unproductive to me because no one seeks treatment at that point.

[newguy]

I'm not sure that I totally agree with the previous message, but aside from that let's not forget about the inflammatory processes at work. All too often it's easy to look at peyronie's from the perspective of existing and often extensive fibrosis and so forth, but if future treatments are able to knock out the inflammatory processes very effectively and very fast, then for many men dealing with peyronie's may simply be a case of taking a short course of treatment to allow normal healing to take place.

I do hope that Xiaflex does hold a place to in teatment of long term sufferers of the condition though. Maybe in conbination with a wide ranging oral treatment regimen (to diminish reoccurence) and traction, thi could prove to be a urprisingly effective mix. The jury seems to be out of Xiaflex for peyronie's right now though.

Intead of saying that treatments don't work at all, maybe it's more accurate to say that they don't cure peyronie's. 

[j]

I think the term "plaque" just confuses things.  It implies some sort of hard deposit that needs to be "broken up".  And the term "calcified" suggests the mineral deposits in an old water pipe.  The reality is  - it's fibrosis, a tangle of collagen and fibrin molecules.  These are proteins - the same ones found in normal, healthy. connective tissue. It's not something brittle that might be shattered by ultrasound.

I've never really understood use of the term "calcified".  It's claimed that this tissue accumulates calcium over time but I have doubts abou the use of this word, too.

Those of us who also have Duputyren's contractures have a sort of sanity check to apply because Dupuytren's is the same thing in another area of the body - the tissue has been found to be virtually identical - and seems to be better understood than Peyronie's.  With Dupuytren's the term "plaque" is never used, no one talks about "breaking up" the plaque, and ultrasound is known to have no effect.  It's just fibrosis, period.  Dupuytren's tissue doesn't "calcify" either. 

Many things that have been suggested as treatments for Peyronie's have been tried for Dupuytren's years, or decades, ago and found not to work. Vitamin E, Potaba, various antioxidants, accupuncture, NSAIDs, antihistamines, and of course transdermal Verapamil are all ancient history in the Dupuytren's world, no longer even discussed.  All sorts of systemic meds have been tried and in the end, Xiaflex (collagenase) is the only one to show real effect, and attract investment.  Everything else has faded away.

[George999]

OK guys, I see where your coming from on this and, as I said before, I'd be delighted to be proven wrong.  I thoroughly agree that it should be investigated further.  Once again, the problem becomes finding the funding, thats the ditch we always seem to end up in.     - George

[Maverick]

Haaa... this reads like a bunch to scientists working in a lab speculating what the big red button on the table does...
Ultrasound has many frequencies, power levels and hence applications. Focused high frequency high intensity ultrasound is the one used to break stones and has recently been used in treating/burning off fibroids in women (search for it on youtube) whereby the "focused" ultrasound directs the energy into one exact location, thereby creating enough energy at that location to essentially burn the tissue or break the stone. In regards to Peyronies Disease (rather potential Peyronies Disease application), the ultrasound used is not focused, and thereby creates vibrations over a larger surface area at the cellular/molecular level, stimulating tissue and increasing blood flow. Picture body tissue now, one side of which is softer and "healthier", and the other side which is harder and "unhealthier". Apply ultrasound at the invisible line where the two sides touch. Ultrasound creates vibrations so that this "line" starts to get blurred, and the blood flow from the healthy side starts to have openings and space where it can start getting into the unhealthy side and stimulating the area. The plaque being denser than the softer tissue, will actually be hit by more sound waves where since the cells are closer together, the waves are not able to pass right through. In the softer tissue where the blood flows freer amongst the cells, there is space amongst the cells to let the sound waves through.
That's a basic concept of ultrasound in regards to Peyronies Disease. Also, I'm not one to see the cup as half full, but I have yet to read on ultrasound therapy going wrong when applied to Peyronies Disease or other medically similar applications, so if anyone has concrete medical references or articles, please point me to them. I'm not saying this is a cure, I'm just wondering why more people don't try it.

[ocelot556]

Good point, George - but if the plaque is broken up via ultrasound, wouldn't it immediately become more pliant? A la the Leriche technique, by creating space between the binding tissue, you can extend it? I agree, though, it would be difficult to remove all calcification from the site. Of course, perhaps if you could break the calcified plaque down enough that a chelating agent might be more effective?