PD48-06 OUTCOMES ASSOCIATED WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM TREATMENT FOR PEYRONIE'S DISEASE BY DURATION OF DISEASE

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Peyronie's Disease1 Apr 2015PD48-06 OUTCOMES ASSOCIATED WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM TREATMENT FOR PEYRONIE'S DISEASE BY DURATION OF DISEASE Laurence A. Levine, Martin K. Gelbard, James P. Tursi, Ted M. Smith, Gregory J. Kaufman, Kimberly Gilbert, Jed Kaminetsky, and John P. Mulhall Laurence A. LevineLaurence A. Levine More articles by this author , Martin K. GelbardMartin K. Gelbard More articles by this author , James P. TursiJames P. Tursi More articles by this author , Ted M. SmithTed M. Smith More articles by this author , Gregory J. KaufmanGregory J. Kaufman More articles by this author , Kimberly GilbertKimberly Gilbert More articles by this author , Jed KaminetskyJed Kaminetsky More articles by this author , and John P. MulhallJohn P. Mulhall More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2763AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Intralesional injection therapy with collagenase clostridium histolyticum (CCH) is FDA-approved for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and penile curvature deformity (PCD) of at least 30° at the start of therapy. This posthoc analysis examines improvements in PCD and bother related to PD following treatment with CCH or placebo in subjects with PD duration of 6 to <12 months or ≥12 months. METHODS 147 subjects with PD were enrolled in a double-blind, randomized, placebo-controlled phase 2 study at 12 US sites. Males >18 years of age were eligible if they had PCD of 30°-90°. Subjects received intralesional injections of 2 doses of either CCH (0.58 mg/dose) or placebo 24-72 hours apart in 3 treatment cycles, separated by 6 weeks. Subjects were assessed for 36 weeks (last observation carried forward; LOCF) using PCD measurements, responses to a PD-specific patient-reported outcome (PRO) measure, and adverse event (AE) reports. RESULTS In subjects with PD duration of 6 to <12 months (n=22, CCH; n=12, placebo), a 38% mean improvement (mean change -19.4°) in PCD was observed following CCH treatment vs. a 19.8% mean improvement (mean change -8.9°) for placebo (p=0.08). For PD duration of ≥12 months (n=78, CCH; n=22, placebo), a 27.6% mean improvement (mean change -15.2°) in PCD was observed following CCH treatment vs. a 7.3% mean improvement (mean change -3.9°) for placebo (p=0.004). For the bother domain of the PD-specific PRO, similar magnitudes of score improvements were observed for subjects with PD duration of 6 to <12 months (2.4 reduction, CCH vs 0.5 reduction, placebo; p=0.24) or ≥12 months (2.6 reduction, CCH vs 0.9 reduction, placebo; p=0.12). Most AEs in the CCH group occurred at the injection site (penile bruising, pain, edema, contusion) and were mild/moderate in severity; AE profiles were comparable regardless of PD duration. CONCLUSIONS Improvement of PCD was comparable or better for PD duration of 6 to <12 months compared with ≥12 months, although the observed differences were not statistically significant in this dataset. An increased placebo effect was also observed in subjects with a PD duration of 6 to <12 months. Further study of CCH treatment in the early months of PD should be considered. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e968 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Laurence A. Levine More articles by this author Martin K. Gelbard More articles by this author James P. Tursi More articles by this author Ted M. Smith More articles by this author Gregory J. Kaufman More articles by this author Kimberly Gilbert More articles by this author Jed Kaminetsky More articles by this author John P. Mulhall More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...