BOTOX for Peyronies Disease: Clinical Study by Baylor College of Medicine - Recruitment

[MikeSmith]

thanks for providing those abstracts. But, the evidence they present is rather weak and circumstantial at best. If it was thought that Peyronies Disease might be due to an immune response, why hasn't anyone tried immunomodulation therapy that is commonly used for autoimmune diseases--like steroids?

they have.  steroid injections dont work on the plaques and they have side effects like atrophy or addtl calcification.  they can work for the pain, though. 

[abraxis]

Peyronies Disease is not likely an immune system problem. The cause is not understood, but it makes no sense that the immune system causes it. I am a PhD immunologist.

"Peyronie's Disease is Associated with an HLA Class II Antigen, HLA-DQ5, Implying an Autoimmune Etiology"
http://www.jurology.com/article/S0022-5347%2801%2965579-4/abstract

"The Immunological Features of Peyronie's Disease"
http://www.jurology.com/article/S0022-5347%2801%2966582-0/abstract

"Is There An Immunogenetic Basis for Peyronie's Disease?"
http://www.jurology.com/article/S0022-5347%2801%2965363-1/abstract

According to the literature, and the above is just a tiny sampling, an immune response (inflammation) leads to the formation of Peyronie's plaques. Why does it happen in some men and not others? That's the million dollar question.

-Skjald

thanks for providing those abstracts. But, the evidence they present is rather weak and circumstantial at best. If it was thought that Peyronies Disease might be due to an immune response, why hasn't anyone tried immunomodulation therapy that is commonly used for autoimmune diseases--like steroids?

[bummedout]

Smart man.  Two years ago I let a urologist inject me with something to "evaluate" my peyronies.  He ended up making things a lot worse, to the point that I'm almost completely dysfunctional at 30 now.

[fubar]

Ben

Maybe my post was obscure,I have no intention to try botox. Also I have no intention in self injection or having anything injected into my penis.

I am using a ved to treat my peyronies along with medication and supplements. Thank you for your concern.

Fubar

[Ben]

Fubar : autologous grease injection too can make you penis puffy but it not life lasting. 100 % not harmful. Try the Ved, the Bathmate and Fast Size stretcher it really work if you give it time.


The swisscheesing effect that is mentionned sometimes is called in France "dilacération" or Leriche's technique. Leriche is an uro and surgeon...
It's done with a 18 gauge needle (take it carefully because I don't know it gauge are the same in Europe and US).
If you had already done caverject shots, and look for the swisschessing effect, you can do it by yourself. All you need is a needle, and a peyronie's plaque.

But the benefits/risk ratio is poor when dealing about needle and penis, nobody in France do this procedure (Leriche technique). Sometime a MD or Uro claims to have the cure for this disease (I remember Italians like Subrini with his softs implants).

I don't want to start Xiaflex or Botox before the results are well known.

[fubar]

Lennyman:

I wanted to use the same reaction yesterday to a post. But women have been using it for years to stretch scars and make things puffy.

If botoxin can fill my indention and make my bend appear less. What the hell and get me through a date .I will try it, lets support our Guinea pigs that we all are.

I will  be apart of a different experiment that does not send  nerve killing agents from the sea directly into my penis. Sorry have to sit this one out with, lennyman.

No thank you,fubar

[Lennyman]

ok- even crazier than using the stretcher in my opinion is injecting botox.  You gotta be F--in joking, right??!!   Lennyman

[Tim468]

>>The consent form states: "We think that injecting Botox (R) into the penis might prevent plaque formation and promote plaque breakdown as seen by reducing bending of the penis." <<

Wow. In other words, they do not seem to have an hypothesis. Not even a wild guess as to why a smooth muscle paralytic agent might help.

This does go back to the older model of "transformed myofibroblasts" leading to scar contracture. The idea was that myocytes (progenitor muscle cells were transformed into more fibrotic cell typs that contracted more like a scar than a muscle. The role of blocking acetylcholine release in preventing scars is foggy to me - at best.

http://en.wikipedia.org/wiki/Botulinum_toxin

Tim

[jayhawk]

This concept sounds reasonable and might work, Needle Aponeurotomy seems to be effective in treating  dupuytren's contracture! The problem with Peyronies is keeping the needle sites in the plaque open allowing the Swiss Cheese effect to work!  Botox could be the solution.
Just a Thought,
Jayhawk 

[GS]

starman,

It's great to hear some good results from someone that's in a clinical trial.  Please keep us all posted on how this all works out for you.

It appears that the trial is still recruiting and based on your experience, it doesn't sound that bad.  I'm a long way from Houston or I would contact them.

I look forward to hearing more about the trial and wish you the best.

GS

[starman]

After the 2nd injection there is more improvement.  My wife confirms this. Curvature has been reduced and girth and length has increased.  Not back to original size but much improved. The injections are not painful, after the initial injection to deaden the area.  There has been no pain after the injections.  I had the 3rd injection on July 20th.  It may be the "swiss cheese" effect that others have written about, but whatever it is it is working.  I have asked the PA about why it is thought that Botox would keep the palque from reforming. The consent form states: "We think that injecting Botox (R) into the penis might prevent plaque formation and promote plaque breakdown as seen by reducing bending of the penis." He told me there are a lot of "drugs" that work and there is no known reason that they work.  I know I have read articles about that.  I have not asked the doctor but will approach that next chance I get.  With this condition it is highly unlikely that one would experience a placebo effect.  This may be why the PA could "tell" which patients received the Xiaflex even if it did not work in every patient.  I know in my situation the results (even though I did not try to use a tool to measure the curvature) are easily noticeable.  The results have not been "slight", the results are very noticeable.  There is always the chance that the plaque goes away without any treatments as is does sometimes, from what I read usually within the first year.  My condition had been stable for about 2 years.  Botox side effects and issues have been well documented since is has been fairly widely used for cosmetic results for sometime now.  Four weeks after the fourth injection they will repeat the procedures done at the beginning, shot to make erection, digital pictures, and ultrasound measurements.  At that time I may be able to find out more exactly how much improvement there has been.  I hope there is an actual measurement that I can get.  Right now we believe that I have had about a 50% improvement in curvature and about the same in girth and length.  I wish I had take my own pictures for comparison before the procedures begin, but I did not think of that.  Starman 

[MikeSmith]

TO:Mike Smith. Reason why Botox might work.
I contacted the urologist conducting the experiment. He said that the physical insertion of the needle (swiss cheese effect) may have some ameliorative effect and that it is hoped that Botox will prevent or delay the scar tissue process from reoccuring.

Interesting...that's the same reasoning my uro gave me behind verapamil.  Hopefully botox works better.

[Skjaldborg]

Peyronies Disease is not likely an immune system problem. The cause is not understood, but it makes no sense that the immune system causes it. I am a PhD immunologist.

"Peyronie's Disease is Associated with an HLA Class II Antigen, HLA-DQ5, Implying an Autoimmune Etiology"
http://www.jurology.com/article/S0022-5347%2801%2965579-4/abstract

"The Immunological Features of Peyronie's Disease"
http://www.jurology.com/article/S0022-5347%2801%2966582-0/abstract

"Is There An Immunogenetic Basis for Peyronie's Disease?"
http://www.jurology.com/article/S0022-5347%2801%2965363-1/abstract

According to the literature, and the above is just a tiny sampling, an immune response (inflammation) leads to the formation of Peyronie's plaques. Why does it happen in some men and not others? That's the million dollar question.

-Skjald

[abraxis]

There is a protocol in Europe where a needle is used to punch holes in the plaque and evidence suggests that it is effective. Unfortunately, it does not seem to be offered in the US.

[abraxis]

Mike Smith:
"I don't understand why a toxin that would cause a greater immune response could possibly help in this condition which is largely due to an overractive immune response.  Is it supposed to turn the immune system against the plaque? "

Peyronies Disease is not likely an immune system problem. The cause is not understood, but it makes no sense that the immune system causes it. I am a PhD immunologist.

[abraxis]

I am new here.  Just found this forum today.  I am in the botox study at Baylor.  Same Dr. participated in the Xiaflex study.  The PA told me about the that study, including the popping.  He told me that he saw significant results in the participants who received the Xiaflex and no results in those that did not as expected. 


Unfortunately, the PA would not know who received Xiaflex and those who did not. Studies like these are "blinded" so that the practitioner and patient do not know what they are getting.

[ohjb1]

TO:Mike Smith. Reason why Botox might work.
I contacted the urologist conducting the experiment. He said that the physical insertion of the needle (swiss cheese effect) may have some ameliorative effect and that it is hoped that Botox will prevent or delay the scar tissue process from reoccuring.

[MikeSmith]

I don't understand why a toxin that would cause a greater immune response could possibly help in this condition which is largely due to an overractive immune response.  Is it supposed to turn the immune system against the plaque?   Couldn't be... we could just start injecting melanomas with botox then... no need to remove them. 

One off label use of botox in trials now that seems promising is for acne, because it paralyzes the sebaceous glands...again, the key function is an interruption of signals.  How it could work in Peyronies Disease is very questionable (though I'm happy to hear you had results from the first shot).  Is the hardening tunica seen as equivalent to a facial wrinkle that  can be relaxed with botox somehow?  That's the only connection I could see...which I could also argue against... but I'll just leave it there.

Starman, did you ask how they think this works?  What muscle are they paralyzing?  Why wouldn't the immune system react to the botox as a foreign toxin & create more scar tissue & inflammation?

[MedStudent86]

Efficacy needs to be proven for a drug to be approved. However, the standard at which efficacy is measured is quite subjective. It is not enough to simply say a drug "works." What does that really mean? Well, it could mean a 50% reduction in curvature, or a 5% reduction in curvature. The main concern of the FDA is drug safety.

I am new here.  Just found this forum today.  I am in the botox study at Baylor.  Same Dr. participated in the Xiaflex study.  The PA told me about the that study, including the popping.  He told me that he saw significant results in the participants who received the Xiaflex and no results in those that did not as expected.  For the botox study they did ultrasound measurements flaccid and then with an erection.  They also took digital pictures that would be analyzed on computer and compared with pictures from future visits.  The 20 to 30 injections are very small injections and according to the PA who does Verapamil on about 20 patients, that is the same way they do those.  The not objective results from my first round was positive.  My wife actually noticed and commented about the change in curve, length and girth with out me even asking.  The PA said that the studies were for safety evaluations for the FDA.  Does anyone think that there has to be a proven positive result in a large percentage for a drug to get approval?  Look at Verapamil, not that effective, look at the results.  The PA practically said that.  He said that the results he saw with the Xiaflex were significant and more widespread.  The PA was telling me he is seeing improvement with the botox but not as quickly as with the Xiaflex.  He did say that the botox would be less expensive. 

I go to appointment #2 this next week.  I'll post again after that.

I go back next week for the next round.

[j]

starman, did any of the MDs or PAs give you an explanation of why and how Botox should affect Peyronie's?  Or whether the improvement would be permanent?

[lwillisjr]

Thanks for posting and keep us updated.

[starman]

I am new here.  Just found this forum today.  I am in the botox study at Baylor.  Same Dr. participated in the Xiaflex study.  The PA told me about the that study, including the popping.  He told me that he saw significant results in the participants who received the Xiaflex and no results in those that did not as expected.  For the botox study they did ultrasound measurements flaccid and then with an erection.  They also took digital pictures that would be analyzed on computer and compared with pictures from future visits.  The 20 to 30 injections are very small injections and according to the PA who does Verapamil on about 20 patients, that is the same way they do those.  The not objective results from my first round was positive.  My wife actually noticed and commented about the change in curve, length and girth with out me even asking.  The PA said that the studies were for safety evaluations for the FDA.  Does anyone think that there has to be a proven positive result in a large percentage for a drug to get approval?  Look at Verapamil, not that effective, look at the results.  The PA practically said that.  He said that the results he saw with the Xiaflex were significant and more widespread.  The PA was telling me he is seeing improvement with the botox but not as quickly as with the Xiaflex.  He did say that the botox would be less expensive. 

I go to appointment #2 this next week.  I'll post again after that.

I go back next week for the next round.

[Lennyman]

  You gotta be outa your F---IN  mind to participate in this. Just my 2 cents.  Lenny

[j]

I suspect there is no real scientific basis for this treatment, just a desire to sell more Botox.

[BrooksBro]

Since my doc is the urology department head there, I found this very interesting.  I am not part of the study, and he has not metioned it to me during my previous visits.  At 20-30 injections, I am not excited about being a part of it either!  If I can remember it, I will ask about the study progress when I next see him in late May.  Sub-Investigator: Larry I. Lipshultz, MD     

[slowandsteady]

I half didn't expect this to be real, but: http://clinicaltrials.gov/ct2/show/NCT00812838

"Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque"

Still, botox???

[skunkworks]

link?

[Briden]

Greetings,

Apologies if this has been covered on another thread..

The National Institute of Health has a many medical research trials happening all the time..

On their site I did a search for Peyronie's trials and found the following trial to be interesting titled: H-22411: BOTOX® for Peyronie's Disease

Check it out..

Thanks,
Briden