Evaluating Low Intensity Shockwave Therapy with Collagenase Injection for Treating Peyronies Disease in Men

What this Trial Is About

Researchers are studying Peyronies Disease and erectile dysfunction to find out if combining low-intensity shockwave therapy LiSWT with Xiaflex Collagenase Clostridium Histolyticum injections improves the curvature of the penis better than Xiaflex injections alone. The trial aims to compare these treatments in men with stable symptoms and specific curvature measurements. This randomized study is sponsored by Mayo Clinic and focuses on clinical outcomes related to symptom bother, sexual intercourse ability, and erectile function. Participants will be randomly assigned to one of two groups. One group will receive eight Xiaflex injections divided into four series, with two injections each, spaced 1 to 7 days apart, combined with four sessions of low-intensity shockwave therapy given before each injection series. The other group will receive the Xiaflex injections alone as per standard care without shockwave therapy. The shockwave therapy involves delivering 1,500 shocks at a set rate and power using a specialized device. During the study, participants will be evaluated at the start and after six weeks for changes in symptom bother, ability to have penetrative sexual intercourse, need for surgical straightening, and erectile function measured by the International Index of Erectile Function IIEF-EF. Researchers will monitor responses to treatment using physical assessments and questionnaires. The total duration of participation covers the injection series and follow-up assessments to track improvements and safety.

Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease