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Welcome to Dr. Landon Trost - Directly answering member questions in the "Medical Professionals" section below the Treatment boards. https://www.peyroniesforum.net/index.php/topic,16512.0.html

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Author Topic: BOTOX for Peyronies Disease: Clinical Study by Baylor College of Medicine - Recruitment  (Read 19987 times)

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Briden

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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


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skunkworks

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This is an emotionally destructive condition, we all have it, let's be nice to each other.

Review of current treatment options by Levine and Sherer]

slowandsteady

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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???
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BrooksBro

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  • Houston TX, Peyronie's 2009, Dr. Larry Lipshultz

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     
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j

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

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

starman

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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.
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Starman

LWillisjr

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  • 65 y/o - 13 yrs Peyronies free
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Thanks for posting and keep us updated.
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j

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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?
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MedStudent86

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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.
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MikeSmith

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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?
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ohjb1

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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.
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abraxis

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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.
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abraxis

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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.
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abraxis

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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.
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Skjaldborg

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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
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MikeSmith

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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.
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starman

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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 
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Starman

GS

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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
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jayhawk

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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 
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Tim468

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>>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
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52, Peyronies Disease for 30 years, upward curve and some new lesions.

Lennyman

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

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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
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Ben

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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.
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fubar

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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
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bummedout

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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.
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abraxis

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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?
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MikeSmith

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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. 
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starman

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I have completed the 3 treatments and the 4th month ultrasound.  I was informed that I was receiving the botox.  I curvature at the begining of the trial was measured at 45 degrees.  The measurement at the end was 25 degrees which is about what my wife and I had observed see my last post "about 50 percent improvement.  the length and girth were also close to 50 percent improvement.  The woman who did the ultrasound commented on the noticable improvement.  I go back in for a 5 month check to see if the improvement remains.  They will be recruiting for the Xiaflex phase to determine dosage begining in October.  One third of the participants will recieve a base dosage, one third will recieve double and one third will get the saline solution.  I participated in another study that involves a biological "drug" in development for pain relief.  I had shingles 5 years ago and have post herpatic neuralgia, burning, needles and pins pain from just below my eye over my forehead to the back of my head.  This pain is constant and has been since the shingles outbreak.  I no longer have the blisters but still have the pain.  I was taking Lyrica for the pain but was experincing some of the side effects of that drug, however it did reduce the pain about 80%.  I learned about the trial from an recruiting ad in the local paper.  I read about the biological on the internet and there was actually a readers digest article about it being developed with the DOD.  It has the potential to be given to wounded soldiers by IV in the field and the pain relief can last up to 6 months.  I had to go off the Lyrica for a clean out period and was not allowed to use any other pain relievers for a month.  I was miserable but made it.  This was also a 1/3 placebo and 1/3 smaller dosage and 1/3 larger dosage trial.  Within 4 hours of the IV I had better relief than I had with the Lyrica.  I had to keep a log on a palm pilot and go in once a week for ekg's, they took blood every other week, and they I had to take a memory test every week.  (one of the problems with Lyrica was memory problems)  At the end of the study the pain was returning.  This trial did not report to the participants if they got the placebo or the drug or give you an option to continue.  This was about 2 years ago.  They have been doing trials on back pain and knee pain that I know of.  I am hoping that this drug will get approval sometime soon.  (however Phizer owns it and they also have Lyrica) Anyway I will try to get in on the Xiaflex trial if I meet the criteria.  The treatments for the Botox were not very painful.  The most painful part was the shot at the base of the penis to deaden the area.  I did not have any pain after the procedures.  I had to stay in the treatment room and they checked my blood pressure every 15 minutes for about 1 1/2 hours before I could leave.  Then I had a 2 hour drive back home and most days I went to work after I got back.  I work in retail and am on my feet walking around helping customers and stocking and had no problems.  I can tell you that so far I have had no bad side effects and intercourse is very much improved not back to what it was like before but much better for me and my wife. 
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Starman

newguy

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If botox did help this person, can anyone hazard a guess as to how? It's just that I've never really viewed it to be something that would be of use. I guess we should wait until studies come out before drawing any firm conclusions. It'd be good to hear from others who have received this treatment.
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GS

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Starman,

Please keep us updated as to your progress with the Botox.  Since Botox has been on the market for some time now, it would probably be approved for use with Peyronies a lot sooner than the Xaniflex.

And if your curve went from a 45 degree to a 25 degree, that's as good as Xaniflex has been projecting and would be good enough for me.  If I could cut my curvature in half, I would gladly take a few shots.

GS
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newguy

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Starman,

Please keep us updated as to your progress with the Botox.  Since Botox has been on the market for some time now, it would probably be approved for use with Peyronies a lot sooner than the Xaniflex.

And if your curve went from a 45 degree to a 25 degree, that's as good as Xaniflex has been projecting and would be good enough for me.  If I could cut my curvature in half, I would gladly take a few shots.

GS

He also mentioned that his condition had been stable for quite some time. That indeed would be impressive. I want to keep an open mind about this whole area really. Maybe if more people come forward a consensus can start to be formed. I don't quite understand how botox is suppose to relax scar tissue, or how long this is supposed to last for? Has it been tried in any conditions remotely linked to peyronie's?
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starman

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It's been over 3 months and I have actually had a little more improvement in degree of curvature and size.  I really rely on my wife for verification, and she it brutally honest about everything.  I have filled out the consent form for the Xiaflex.  There is a section in it that states "After the study has ended, and if you received the placebo plus modeling in this study, the study doctore may ask if you would like to be in another study to receive the active study drug."  I got an email to set up an appointment for the ultrasound and measurements to see if I qualify for the study.  On the Xiaflex thread there is some concern about how 2/3 get the Xiaflex and 1/3 get the placebo.  This is not the drug company/doctors decision.  I have been in another drug study for my Post Herpatic Neuralgia.  This is painful 24/7, without any drugs I have about an 8 on a 10 scale.  I had to get off Lyrica and take no other pain relievers (Tylenol etc) for a month before I would qualify to be a participant.  It was a bad month but I know I got the IV biological and had relief for a good 6 months.  I just wish they would bring that to market.  Its been a couple of years now.  I know I talked to the urologist when I was getting the Botox treatment and he said he didn't think they should even do the placebo with the Xiaflex because your not going to "believe" the plaque away.  I know some people think they can mind control everything but I don't believe that.   It doesn't hurt to have a positive attitude, and if one has a negative attitude one might sabotage his own situation. 
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Starman

Humorous3

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Starman,

It was interesting to read of your results with Botox but more so to read you are trying to get into the current Xiaflex study.  Since it's been over three months since your Botox treatment, that shouldn't be a problem. Your measurement has to be over 15 degrees (and you are at 25 degrees).  The study has been going on for about two months so keep on top of your forms.  There may not be very many slots left.  Good luck! 

If you get into it, we would like you to join the "Thread for Guys in Xiaflex Trial - Currently or Previously".  I hope you will. 

Humorous
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BSSS

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anyone know how much and if Botox and Xiaflex are related?
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Luciano

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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.
Its called the Leriche technique
to find out more about it :

http://www.google.at/search?q=Leriche+technique

or even here

http://www.peyroniesforum.net/index.php?topic=1024.0

Luc
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MikeSmith0

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anyone know how much and if Botox and Xiaflex are related?

they are unrelated.  botox paralyzes/relaxes  muscles... xiaflex (collagenase) dissolves collagen.  
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rd

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What's funny about botox was when I went to my GP and he asked how my visit to the urologist went I told him how it went and that he said he couldn't really do anything. Then my GP said what about botox. He admitted he didn't know much about peyronies but I told him I had read about one person in a trial on here that had some success. Just thought it was funny he mentioned botox since I havent seen it mentioned anyhwere but here for a possible treatment.
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Luciano

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@Starman
It seems you got that botox treatment about 6 month ago... did your curvature comeback since? or are you stable at 25°?
Any feedback would be more than interesting. (I know you are into xiaflex now, but the botox issue is still of interest)
Luc
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newguy

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Has anyone else here been involved in this botox trial?
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skunkworks

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Where did that abraxis guy go? Was interesting reading that discussion.
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This is an emotionally destructive condition, we all have it, let's be nice to each other.

Review of current treatment options by Levine and Sherer]

Luciano

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I was in a yahoo group for Peyronies Disease,
http://groups.yahoo.com/group/peyroniesdiseasesupportgroup/
problem you got to register and then join the group to see pics.

The group does not seem very active, but there is guy there  that was in the botox trial. He said:

Quote
I posted my needle treatment inprovement in an album on this site. I will go for
final exam in next 2 weeks at Baylor College of Medicine in Houston, Texas.
Wish I had a pretreatment photo; hope to get the one's from the
doctor/researcher. The photos are numbered by treatment number 1 through 4 then
the photo of the series after that treatment. I hope you can see the difference
also. What do you think? I know, I am definitely am straighter. Now to work
on getting back original lenght.

and he posted some pics as jormakivi in the album there. one after each injection.

I seen them. My problem, he didnt have a real curve, but more an angle where the penis touches the body (as far as I understood)
So the pics, for me look all the same.

Luc
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SusanChase

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I'm involved in a clinical trial but not in BOTOX trial and I guess there are big difference because in some clinical trial, you only need to take some medicines but on this, there is an injection process and I know that everyone here are confuse about the possible side effect in a trial but don't worry because I'm sure participating in this kind of trial will never risk your health.
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