(116) Breaking the Silence: Should I Be Concerned About Penile Fracture when Injecting Collagenase Clostridium Histolyticum?

Abstract

Abstract Introduction Collagenase clostridium histolyticum (CCH) was first approved by the FDA in December 2013 for the nonsurgical management of Peyronie’s disease (PD) in men who are otherwise healthy. Penile fracture (PF) is a rare but concerning adverse event with known association with CCH administration. Objective To determine the risk of PF in men with PD who are receiving CCH and correlations between the risk of PF and comorbidities previously excluded in studies investigating the safety of CCH, namely the IMPRESS trial. Methods The TriNetX database was used to measure the rate of hospital visits for penile fracture using the ICD-10 code S39.840A. Results were limited to patients who were diagnosed with PD (ICD-10 N48.9) and were seen between July 2013 to July 2023. Patients were excluded if they had a history of surgical intervention for PD, including plaque excision and grafting, penile plication, and insertion of inflatable penile prosthesis. An odds ratio (OR) was calculated to compare the rates of PF between patients who had and had not received CCH. For those who received CCH, OR’s were calculated to determine if the presence of certain comorbidities increased the risk of PF. Results Within the examined time period, 44,542 patients with PD experienced 280 PF’s. The rate of PF in those who had and had not received CCH were 1.25% (N = 37) and 0.59% (N = 243) respectively, OR 2.122 (95% CI: 1.499-3.001, p<0.0001). Tobacco use, diabetes mellitus, peripheral vascular disease, hypertension, hyperlipidemia, erectile dysfunction, and hypogonadism were not associated with an increased risk of PF in men receiving CCH (p>0.05) (Table 1). Conclusions While the rate of PF following CCH use for PD was low at 1.25%, this was significantly higher than in those who did not receive CCH. Despite this, men who were previously excluded from studies examining the safety of CCH use for PD due to comorbidity burden were without an increased rate of PF, suggesting that these men may be able to receive CCH without additional risk of PF. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Antares Pharma, Clarus Therapeutics, Coloplast.