Introduction: Since FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its comparable efficacy to surgical therapies. The current study objective was to compare various objective and subjective outcome measures between men undergoing CCH or surgery for PD.
Methods: A randomized, controlled trial (NCT04786106) is ongoing. Participants are randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD. Objective, standardized (International Index of Erectile Function [IIEF] and Peyronie’s Disease Questionnaire [PDQ]), and non-standardized assessments are obtained at baseline, and post-treatment at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcome is overall satisfaction. Secondary outcomes include standardized and non-standardized self-assessments, penile curvature, penile length, subsequent interventions, and adverse events.
Results: A total of 40/40 men have been randomized, with 3-month data available on 17 (CCH=8, surgery=9). Mean age was 54.9 years, PD duration 37.4 months, curvature 72.3 degrees, and penile length 12.7 cm. All baseline variables were similar between cohorts. For the primary outcome at 3 months post-treatment, CCH men reported higher overall satisfaction (100% vs 82% surgery, p=0.12). For secondary outcomes, the median differences between CCH and surgery were: IIEF-EFD (+3.5 vs +7, p=0.52), PDQ-physical (-9.5 vs -6, p=0.56, note: lower is better for PDQ scales), PDQ-pain (-5 vs 0, p=0.22), PDQ-bother (-4 vs -8, p=0.56), length change (+1.0 vs -0.5 cm, p<0.01), and curvature degree change (-21 [41%] vs -65 [85%], p<0.01). More CCH men reported improved sexual function (88% vs 70%, p=0.59), erectile function (75% vs 45%, p=0.16), penile length (63% vs 9%, p<0.01), and less impact on sensation (25% less sensation vs 55%, p=0.13), while surgery men were more likely to report satisfaction with curvature (73% vs 50%, p=0.31). 100% of men in both groups would recommend treatment to a friend. When asked which treatment they would pick if starting over, 100% of CCH men reported CCH and/or traction, while 80% of surgery men indicated surgery (p < 0.01).
Conclusions: Preliminary 3-month data suggests that when compared to surgery, CCH results in higher overall satisfaction (not statistically significant), decreased curve improvement, improved penile length, and fewer impacts on erectile function and sensation.
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