1661 CURVATURE DEFORMITY AND SYMPTOM BOTHER IMPROVEMENT OVER TIME IN PATIENTS WITH PEYRONIE'S DISEASE TREATED WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Abstract

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Peyronie Disease + Surgical Therapy1 Apr 20131661 CURVATURE DEFORMITY AND SYMPTOM BOTHER IMPROVEMENT OVER TIME IN PATIENTS WITH PEYRONIE'S DISEASE TREATED WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM Christopher McMahon, Stephen Auerbach, Genzhou Liu, James Tursi, Nigel Jones, and Arthur Burnett Christopher McMahonChristopher McMahon St. Leonards, NSW, Australia More articles by this author , Stephen AuerbachStephen Auerbach Newport Beach, CA More articles by this author , Genzhou LiuGenzhou Liu Malvern, PA More articles by this author , James TursiJames Tursi Malvern, PA More articles by this author , Nigel JonesNigel Jones Windsor, United Kingdom More articles by this author , and Arthur BurnettArthur Burnett Baltimore, MD More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.3075AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies (IMPRESS) I and II examined the clinical efficacy of collagenase clostridium histolyticum (CCH) in subjects with Peyronie's disease (PD). The effect of CCH on change from baseline penile curvature deformity and PD symptom bother score using the PD questionnaire (PDQ) was evaluated longitudinally. METHODS The identical IMPRESS I and II randomized, placebo-controlled, double-blind, phase 3 studies enrolled subjects ≥18 years of age with stable PD symptoms for ≥12 months and penile curvature deformity of 30° to 90°. Subjects received up to 8 injections of 0.58 mg CCH given as two injections separated by approximately 24 to 72 hours, with the second injection followed 24-72 hours later by plaque modeling. Each cycle was separated by 6 weeks. RESULTS Figure 1 shows the mean degree of curvature deformity during the study. The mean curvature reduction (Table 1) was significantly greater in the CCH treatment group vs placebo at Weeks 24, 42, and 52 (P < 0.01) in both trials. The 52-week improvement in PD symptom bother was significantly greater in the CCH groups than in placebo groups for both studies (P<0.05). The most frequently reported adverse events (AEs; eg, penile haematoma [or “penile bruising”], penile pain, penile swelling) remained localized to the site of injection; most resolved without intervention. Six subjects experienced treatment-related serious AEs; 3 corporal ruptures and 3 penile hematomas; all were successfully resolved or surgically repaired. CONCLUSIONS Over time, PD patients treated with CCH experienced significant improvements in mean penile curvature deformity and PD bother scores. Clinically significant improvements in penile curvature were rapidly achieved and sustained with CCH treatment. These results indicated that CCH treatment improved some of the physical and psychosexual dimensions of PD consistently over the course of 52 weeks. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e684 Peer Review Report Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christopher McMahon St. Leonards, NSW, Australia More articles by this author Stephen Auerbach Newport Beach, CA More articles by this author Genzhou Liu Malvern, PA More articles by this author James Tursi Malvern, PA More articles by this author Nigel Jones Windsor, United Kingdom More articles by this author Arthur Burnett Baltimore, MD More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...