APDA Medical Advisory Board Position Statement on Treatment

There are many opinions regarding the best treatment approach, but not enough science to support them. Many men who experience Peyronie’s disease have used their own versions of remedies, many or most of which have never been proven to be effective.

It is the strong opinion of the APDA Medical Advisory Board that treatments should be recommended based upon evidence of medical efficacy and safety.

Dr. Levine’s recommendation for nonsurgical treatment

I recommend treatment that involves 3 arms together or in any combination. First arm is a combination of oral pentoxifylline 400 mg three times a day and L-arginine 1000 mg or L-citrulline 750mg twice a day. Although these drugs have not been shown in any large-scale multi-center trials to be effective, there is some evidence that they may reduce the progression of scarring and may have some beneficial effects on scar remodeling and resolution. These drugs are relatively inexpensive, non-toxic, and tend to be well tolerated. Therefore I believe are reasonable to take. I inform my patients that if they experience any side effects, they can simply stop taking the drugs, as there is little evidence of benefit. This combination of drugs should be taken for about 6 months.

The second arm is intralesional injection therapy.  Historically, verapamil was the preferred agent as it is inexpensive and has fewer side effects than interferon.  In the reported experience in over 2,000 patients, approximately 50-60% of patients did have measured reduction of curvature of at least 10 degrees.  It has also been used to accelerate stabilization of the plaque, to reduce progressive scarring and deformity as well as to more rapidly control pain which typically resolves on its own, but may be so bothersome that several intralesional verapamil injections may help resolve it more quickly.  In December 2013, Xiaflex (collagenase clostridium histolyticum) was approved by the FDA for intralesional therapy of men with Peyronie’s disease who have a palpable plaque and at least a 30 degree dorsal or lateral curvature.  Ventral curvatures and curvatures that contain significant calcification were excluded from the study.  Xiaflex has been awaited with much anticipation as it is felt to be a sensible approach to breaking down the scar which is primarily made of collagen, and now that it is FDA approved, it will usually have the benefit of insurance coverage.  The published studies indicated that the average curvature reduction in the men receiving the active drug was just under 18 degrees or a 33% reduction of curvature as compared to about 9 degrees and 18% reduction of curvature for the saline placebo.  The goal of this drug is to enzymatically break down the collagen within the scar while not injuring adjacent structures.  It must be administered by a qualified physician who has gone through appropriate training.  This is because there is potential risk of weakening of the tunic which could result in serious injury to the penis including corporal rupture (penile fracture) due to excessive forces on the softened tissue as well as hematoma, swelling, and pain.  For men who are interested in pursuing treatment they should investigate the Auxilium.com website for physicians who are qualified to administer this drug in their area.

The third arm is external traction therapy. I prefer external traction devices, as they provide prolonged forces on the penis which activate the chemical processes that result in scar remodeling, elongation of the penis, and correction of deformity. I have not seen beneficial effects with vacuum therapy. I believe the reason for this is that the vacuum cannot be left on for an extended period of time; it really provides nothing more than periodic yanks on the penis, which I do not believe activates the beneficial chemical processes seen with prolonged stretching. It is important to use traction therapy carefully, which includes wearing the device for at least 3 hours per day at 2-hour intervals. This means it cannot be worn during extended periods of sleep for fear of injury to the underlying tissue. In over 1,000 patients treated with traction therapy, I have personally not seen any serious adverse side effects. Three men have had temporary abrasions of the skin on the edge of the glans penis, but there have been no negative effects on erectile function or sensation.

Initial evaluation at our medical center using this three-arm protocol demonstrated that approximately 60% of patients had measured improvement of at least 10 degrees, and that in those men who were responders, the average curvature reduction was 27 degrees. In men who used oral and injection therapy without traction therapy, only 50% had measured improvement, with an average curvature improvement of less than 20 degrees.