MP36-06 COMPARISON OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM TO SURGERY FOR THE MANAGEMENT OF PEYRONIE’S DISEASE: A RANDOMIZED TRIAL

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You have accessJournal of UrologyCME1 Apr 2023MP36-06 COMPARISON OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM TO SURGERY FOR THE MANAGEMENT OF PEYRONIE’S DISEASE: A RANDOMIZED TRIAL Jacob Warner, Benjamin Green, Joshua Savage, Klint Brearton, Matthew Ziegelmann, Sevann Helo, Tobias Kohler, and Landon Trost Jacob WarnerJacob Warner More articles by this author , Benjamin GreenBenjamin Green More articles by this author , Joshua SavageJoshua Savage More articles by this author , Klint BreartonKlint Brearton More articles by this author , Matthew ZiegelmannMatthew Ziegelmann More articles by this author , Sevann HeloSevann Helo More articles by this author , Tobias KohlerTobias Kohler More articles by this author , and Landon TrostLandon Trost More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003270.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) 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. Specifically, investigators have compared relative utilization, costs, and outcomes with varying conclusions. The objective of the current study 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. Key outcomes include differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Curvature is measured in two planes and summed to provide a composite curvature. Penile length is measured from pubic symphysis to corona. All therapies were stopped prior to the 3-month time point (i.e. traction and sildenafil). RESULTS: A total of 40 men have been randomized, with 3-month data available on 38 men (CCH=19, surgery=19). Mean age at enrollment was 54.9 years, PD duration 36.6 months (mo), composite curvature 72.3 degrees (deg), and penile length 12.7 cm. All baseline variables were statistically similar between cohorts. Regarding the primary outcome, post-treatment, CCH men reported higher overall satisfaction (3-months: 93.8% vs 84.3% surgery, p=0.16. For secondary outcomes at 3 months, the mean curve improvement was 83.7% vs 53.9% and length change -4.1% vs +6.3% for surgery versus CCH, respectively. The majority of adverse events were higher in the surgery cohort (p<0.01): pain 63% vs 6%, length loss 69% vs 20%, palpable lumps 42% vs 19%, sensation loss 58% vs 19%, and other 16% vs 6%. Skin discoloration was higher in the CCH cohort (6.3% vs 0%). CONCLUSIONS: Preliminary 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. Source of Funding: Endo Pharmaceuticals Grant © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e481 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jacob Warner More articles by this author Benjamin Green More articles by this author Joshua Savage More articles by this author Klint Brearton More articles by this author Matthew Ziegelmann More articles by this author Sevann Helo More articles by this author Tobias Kohler More articles by this author Landon Trost More articles by this author Expand All Advertisement PDF downloadLoading ...