(096) Comparison of Collagenase Clostridium Histolyticum Treatment to Surgery in a Protocol for the Management of Peyronie’s Disease: A Randomized Trial – 3 Year Outcomes
Abstract
Since FDA approval of Collagenase Clostridium Histolyticum for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. We therefore sought to compare key outcomes between the two therapies.
To compare the satisfaction and adverse event profiles between surgery and Collagenase Clostridium Histolyticum injections for the treatment of PD.
A randomized, controlled trial is ongoing. Participants were randomized 1:1 to receive either Collagenase Clostridium Histolyticum + traction (RestoreX) + sildenafil (CCH) or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD (Surgery). Objective, standardized, and non-standardized assessments were obtained at baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment. Key outcomes included differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses.
A total of 40 men were randomized with 36-month data available in 23. Mean age was 54.7 years, PD duration 37.4 months (mo), composite curvature 73.1 degrees (deg), and penile length 12.7 cm. All baseline variables were similar between cohorts. Regarding primary outcomes, consistent with earlier reports, at 36-months post-treatment, CCH men were more likely to report being very satisfied with treatment (54% vs 8%, p<0.01). For secondary outcomes, only questionnaire data were…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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