There is an interesting Phase II clinical trial at Baylor College of Medicine, Houston, Texas about to begin using Botox injections for the treatment of Peyronies Disease (PD.) As you probably know, Botox is an anti-aging, skin care product used to eliminate facial wrinkles.
It will be a randomized, placebo controlled, single center trial with enrollment of approximately 20 men who are in the inactive phase of PD (they have had PD for at least 1 year). Study participants will receive approximately 20-30 injections of 100 units of Botox or a placebo given with a 20 gauge needle directly into the plaque. The study is sponsored by Allergan, makers of Botox, and will end in January 2011.
I had a number of questions about the study and emailed the Principal Investigator, Mohit Khera, MD, MBA and he was gracious enough to respond to my inquiries.
My first question to Dr. Khera was, why does he think that Boxtox will help men with PD? His response was that he believes that Botox inhibits scar formation. He wrote a paper in 2004 demonstrating that men with urethral scars who received Boxtox were less likely to have a recurrence of scarring. He believes the same will be true in regard to PD.
My follow up clarification question to Dr. Khera was, did he believe Boxtox would prevent further scarring or reverse the already present scarred tissue? His response was that if look at all the placebo arms for the major studies that use injection therapies, the placebo arm also has a significant improvement in curvature. It is believed that the needle passing 20-30 times reduces and destroys the plaque. Unfortunately, the scar tissue has a tendency to reform. Thus, if you put a substance in the plaque that inhibits the scar tissue from reforming again, such as Boxtox, a favorable outcome will result
My comments: a few years ago there was a potentially promising surgical procedure known as the Leriche Technique that consisted of the percutaneous tear of the PD plaque with an 18 gauge needle. It seemed very promising with an approximately 70% improvement rate. The conclusion of one study noted that the Leriche Technique was a simple, minimally invasive technique with satisfactory results without any short or long term complications. For some unknown reason, articles about this technique stopped appearing, so I have to assume it was not a long term success. Maybe it offered temporary improvement and the scarring returned along with the symptoms. Hopefully, the use of Botox will result in a favorable, long term outcome.
Another cautionary note. I have read a number of PD studies which test injections of various substance and there was some improvement in some members the placebo group, but I have never seen any study that concluded definitively that the needle itself caused the improvement. There was one study in NY where the urologist said in a off the cuff way that there was some improvement in the placebo group and we don’t know why, maybe it was the needle.
Dr. Khera is a well respected physician and it is positive that there is at least some interest in our medical condition. To link to the clinical trial announcement about this study click HERE.