(166) Characteristics of Veterans Suffering Corporeal Rupture after Collagenase Clostridium Histolyticum

Abstract

Abstract Introduction Collagenase clostridium histolyticum is the only guideline and US FDA approved intralesional treatment for Peyronie's disease (PD). The most feared complication is corporeal rupture which occurs in less than 0.5% of treated patients. In the largest clinical trial, only 3 occurred, however this was enough to include a black box warning and recommend patients to abstain from sexual intercourse for 6 weeks. To date, there have been few studies evaluating the timing and causes of fracture after injection. Objective To determine the incidence and factors leading to penile fracture in men with PD treated with CCH. Methods We queried the VA Informatics and Computing Infrastructure, to identify veterans with a diagnosis of PD by ICD-9 (607.85) or ICD-10 (N48.6) code between 2015-2020. We searched medication codes for CCH and ICD-9 (959.13) and ICD-10 (S39.840) codes for penile fracture to determine which patients had fractures. All patients with penile fracture codes were manually reviewed. Only patients with penile fractures after administration of CCH were included in the study. Results In total, 17,647 veterans were diagnosed with PD with 1,541 (8.7%) treated with CCH. In total, 11 patients (0.7%) had penile fracture after treatment with CCH. Table 1 shows patient demographic and clinical information for 11 patients with penile fracture post CCH treatment. Within these 11 patients, the median number of CCH injections was 6 with a median initial curvature of 35°. Fracture occurred at a median of 8 days after CCH injection with all occurring secondary to spontaneous ejections or sexual intercourse. Finally, 6 patients had their fracture repaired with surgery while the remaining were managed conservatively. Conclusions The highest risk of penile fracture appears to be within two weeks of the second injection of a CCH cycle. Only one fracture occurred after three weeks, and one occurred after the first injection of a cycle. Our data supports the warning to avoid sexual activity for 4 weeks after CCH injection. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo pharmaceuticals.