1658 COMPOSITE RESPONDERS SHOWED IMPROVEMENT IN BOTH PENILE CURVATURE DEFORMITY AND SYMPTOM BOTHER IN TWO LARGE DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 STUDIES OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM IN THE TREATMENT OF PEYRONIE'S DISEASE

Abstract

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Peyronie Disease + Surgical Therapy1 Apr 20131658 COMPOSITE RESPONDERS SHOWED IMPROVEMENT IN BOTH PENILE CURVATURE DEFORMITY AND SYMPTOM BOTHER IN TWO LARGE DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 STUDIES OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM IN THE TREATMENT OF PEYRONIE'S DISEASE Wayne Hellstrom, Robert Feldman, Ted Smith, Sue Hobson, James Tursi, and Guy Bernstein Wayne HellstromWayne Hellstrom New Orleans, LA More articles by this author , Robert FeldmanRobert Feldman Middlebury, CT More articles by this author , Ted SmithTed Smith Skillman, NJ More articles by this author , Sue HobsonSue Hobson Skillman, Macedonia More articles by this author , James TursiJames Tursi Skillman, Macedonia More articles by this author , and Guy BernsteinGuy Bernstein Bryn Mawr, PA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.3072AboutPDF 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). These large, international, identical phase 3 randomized, double-blind, placebo-controlled studies examined CCH treatment outcomes in penile curvature deformity and PD symptom bother domain using the Peyronie's disease questionnaire (PDQ) from baseline to 52 weeks. Composite responders showed both a ≥20% improvement in penile curvature deformity and an improvement of ≥1 in the symptom bother PDQ score, or a change from reporting no sexual activity at screening to reporting sexual activity. The percentage of subjects who were composite responders was compared between CCH treatment and placebo groups. METHODS The IMPRESS I (N=417) and II (N=415) phase 3 studies examined CCH treatment through a maximum of up to 4 treatment cycles, each separated by a 6-week period. Subjects received up to 8 injections into the Peyronie's plaque of 0.58 mg CCH, two injections per cycle separated by approximately 24 to 72 hours, with the second injection in each cycle followed 24-72 hours later by plaque modeling. Subjects were stratified by degree of penile curvature deformity at baseline (30° to 60° vs 61° to 90°) and randomized to CCH or placebo (2:1 in favor of CCH). A post-hoc meta-analysis combined data from the two identical studies. RESULTS The group of men who received CCH treatment had a significantly greater percentage of composite responders compared with the placebo group at Week 52 (p<0.0001; Figure 1). CONCLUSIONS Conclusions. The IMPRESS I and II studies support the clinical efficacy of CCH treatment compared with placebo for both the physical and psychological aspects of PD. CCH treatment resulted in a greater percentage of men showing improvement in both penile curvature deformity and PD symptom bother. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e682-e683 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Wayne Hellstrom New Orleans, LA More articles by this author Robert Feldman Middlebury, CT More articles by this author Ted Smith Skillman, NJ More articles by this author Sue Hobson Skillman, Macedonia More articles by this author James Tursi Skillman, Macedonia More articles by this author Guy Bernstein Bryn Mawr, PA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...