Treatment of peyronie's disease with combination of clostridium histolyticum collagenase and penile traction therapy: a prospective, multicenter, single-arm study.

ABSTRACT

The aim of this paper is to analyze our experience with intraplaque administration of collagenase from Clostridium Histolyticum (CCH) together with penile modeling for selected patients with Peyronie's disease (PD). We conducted a prospective, multicenter, single-arm study. Patients were included from October 2015 to August 2019. We carried out the I + E PROTOCOL (IMPRESS + extender). Each cycle involved administration of two injections of CCH separated 24-72 h, up to a maximum of four cycles. 24-48 h after injection patients underwent penile modeling maneuvers with the use of a PTD at home for at least 4 h a day. After each cycle, penile curvature was evaluated by the Kelami test. Mean pretreatment curvature was 57° (30-100). Eighty-seven patients underwent at least a single cycle and were eligible for analysis. Mean number of cycles administered was 2. Final average curvature after treatment, regardless of the number of cycles was 34°, with a mean reduction in curvature of -23.29° (-41%). Across the first three cycles we found statistically significant differences in the means in terms of the degrees of curvature after each cycle (p < 0.05), however this was not maintained in the fourth cycle. Statistical significance was also found when comparing the initial and final curvature after the complete treatment. We can conclude that treatment with CCH for PD is safe and effective. The concomitant use of CCH and PTT may limit the number of treatment cycles necessary to optimize outcomes when compared with CCH alone.