Efficacy of a Step-wise Protocol in Optimizing Collagenase Clostridium Histolyticum Outcomes in Men With Peyronie's Disease

What this Trial Is About

This research aims to evaluate a step-wise treatment protocol using collagenase Clostridium histolyticum (CCH) injections for men with Peyronie's Disease who have not responded to initial treatments. The study focuses on a modified injection technique with limited in-office modeling, assessing safety and effectiveness compared to previous data. It also involves sexual partners who will provide feedback on their support during treatment. Participants will receive up to four series of CCH injections administered on back-to-back days, with a total dose of 0.9 mg per series diluted to 0.8 mL. Mild in-office modeling is performed on the second treatment day of each series, along with wrap applications to reduce bruising. Men will take sildenafil 25 mg nightly starting on treatment day 2 and use Restorex daily beginning post-injection day 3, continuing both until six weeks after the final injection. If patients are not satisfied after four series, they may enter a salvage phase 9-12 months later, receiving up to two additional series with more aggressive modeling. During the study, participants and their partners will complete questionnaires at baseline, before each series, six weeks after the fourth series, and one year after the final injection. Researchers will measure penile curvature and length at one year, along with therapy adherence, satisfaction, adverse events, and partner support. The total study duration extends to one year post-treatment, with ongoing safety and efficacy monitoring throughout.

Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease