PD45-04 NON-INDUSTRY SPONSORED SAFETY ANALYSIS FOLLOWING COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (XIAFLEX®) INJECTION IN MEN WITH PEYRONIE’S DISEASE

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Peyronie’s Disease1 Apr 2016PD45-04 NON-INDUSTRY SPONSORED SAFETY ANALYSIS FOLLOWING COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (XIAFLEX®) INJECTION IN MEN WITH PEYRONIE’S DISEASE Ryan Owen, Chris Winter, Michael Jennings, Jonathan Angelle, Wesley White, LeRoy Jones, and Edward Kim Ryan OwenRyan Owen More articles by this author , Chris WinterChris Winter More articles by this author , Michael JenningsMichael Jennings More articles by this author , Jonathan AngelleJonathan Angelle More articles by this author , Wesley WhiteWesley White More articles by this author , LeRoy JonesLeRoy Jones More articles by this author , and Edward KimEdward Kim More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2104AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES In 2013, the FDA approved collagenase clostridium histolyticum (CCH) (Xiaflex®) for use in men with Peyronie's disease who demonstrate a palpable penile plaque and penile curvature of >30°. Currently, there is limited data on the clinical outcomes since approval of this medication. Given this gap in knowledge, we conducted a review of all patient visits for CCH administration with the aim of reporting on real world clinical outcomes and adverse effects. METHODS After IRB approval, a retrospective study from 2 large-volume centers was conducted to assess patient outcomes and complications associated with CCH injection. Eligible study candidates included those with documented penile curvature of between 30° and 90° and a palpable penile plaque. The risk evaluation and mitigation strategy (REMS) protocol was followed as described in the CCH prescribing information. Adverse events and treatment response were documented after each patient encounter. RESULTS Fifty-five men received 338 plaque injections with CCH from April 2014 thru August 2015. Of the 55 men identified, 36 (65.5%) experienced penile, suprapubic or scrotal ecchymosis. Additional adverse effects included post injection penile erythema (30.9%), penile pain (23.6%), penile edema (18.4%), hematoma formation (9.1%), penile blister (7.3%), penile hemorrhage (3.6%) and corporal rupture (3.6%). One corporal rupture occurred with aggressive vacuum erection device use within 2 weeks of CCH injection. The injury was diagnosed with pelvic MRI and required no operative intervention. The second occurred with penile fracture during sexual activity 4 weeks after the first cycle and operative intervention was required. Plaque softening was observed in 50 (89.5%) men while 41 (73.7%) reported improvement in curvature. CONCLUSIONS CCH is a safe and effective treatment option for men with Peyronie's disease. Minor adverse effects may be anticipated but are typically short lived. This study emphasizes the need for strict compliance with the REMS program, as corporal rupture is being reported in real-world clinical experience. Physicians administering Xiaflex® need to be able to manage corporal rupture. Additionally, the majority of men report improvement in penile curvature and plaque composition. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e1062 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Ryan Owen More articles by this author Chris Winter More articles by this author Michael Jennings More articles by this author Jonathan Angelle More articles by this author Wesley White More articles by this author LeRoy Jones More articles by this author Edward Kim More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...