Mp28-13 Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie’s Disease Among Prior Non-Responders: A Randomized, Controlled, Single-Blinded Study

You have accessJournal of UrologySexual Function/Dysfunction: Peyronie's Disease (MP28)1 May 2024MP28-13 EFFICACY OF A NOVEL COLLAGENASE CLOSTRIDIUM HISTOLYTICUM PROTOCOL FOR PEYRONIE'S DISEASE AMONG PRIOR NON-RESPONDERS: A RANDOMIZED, CONTROLLED, SINGLE-BLINDED STUDY Henry Larson, Joshua Savage, Klint Brearton, Riley Warner, Matthew Ziegelmann, Sevann Helo, Tobias Kohler, and Landon Trost Henry LarsonHenry Larson , Joshua SavageJoshua Savage , Klint BreartonKlint Brearton , Riley WarnerRiley Warner , Matthew ZiegelmannMatthew Ziegelmann , Sevann HeloSevann Helo , Tobias KohlerTobias Kohler , and Landon TrostLandon Trost View All Author Informationhttps://doi.org/10.1097/01.JU.0001008872.42208.7a.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie's disease (PD) men who have previously failed a first series of injections. We sought to evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. METHODS: A randomized, controlled trial (NCT05108558) is ongoing. All participants previously failed to achieve≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH+traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. RESULTS: A total of 28/40 men have been randomized to date, with 13 having fully completed treatment. Mean age was 64 years, with a median PD duration of 34 months. Mean composite baseline curvature was 67 degrees, with 44% having hourglass or indentation deformities, 10% calcification, median baseline IIEF-EFD 16, and 63% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 18.8), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (63% vs 30% satisfied, 7% neutral). Of the 13 men who had completed the study protocol, 54% required 1 series, 8% 2 series, 31% 3 series, and 8% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (mean 65 degrees vs 15, p<0.05). IIEF-EFD was non-statistically higher in treated men (0 vs -2.5, p=0.07). 100% of men reported a subjective major improvement in curvature, with the average subjectively estimated improvement 90%. 67% reported improved sensitivity (33% no change), while 60% reported improved or no change in erectile function, with 20% unsure, and 20% somewhat worse. Post-treatment, 88% of men were very satisfied with CCH as a treatment and 17% somewhat satisfied. CONCLUSIONS: Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. Source of Funding: Endo Pharmaceuticals © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e477 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Henry Larson More articles by this author Joshua Savage More articles by this author Klint Brearton More articles by this author Riley Warner 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 ...