Peyronie's disease patients with pain: a post hoc analysis of the IMPRESS I/II studies

Significant clinical variations exist in the definitions of acute/active vs. chronic/stable Peyronie's disease (PD), limiting treatment options. To determine whether penile pain should inform PD treatment timing, we analyzed the association between baseline penile pain levels and treatment efficacy using data from the IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I/II studies of collagenase clostridium histolyticum (CCH).

A post hoc analysis of pooled data from 2 phase 3 randomized double-blind trials of CCH in PD (IMPRESS I, NCT01221597; IMPRESS II, NCT01221623) was conducted. CCH-treated participants were stratified by baseline penile pain levels using investigator-assessed and patient-reported measures. A subgroup analysis stratified participants with Any Pain by disease duration.

At total of 364 CCH-treated men were included. Mean penile curvature improvements at week 52 were similar across all 4 investigator-assessed and patient-reported penile pain measures (35.0-36.7% improvement for the No Pain group vs. 32.2-33.9% improvement for the Any Pain group, P=0.14-0.65). Among those experiencing Any Pain, no statistical differences were observed in men with shorter (12-18 months; 21.8-34.8% improvement) vs. longer (>18 months; 31.4-36.8% improvement, P=0.20-0.95) disease durations.

Men with PD who were treated with CCH experienced similar curvature improvements regardless of baseline pain status or disease duration among those who experienced any pain. Findings support the literature that demonstrate similar efficacy when treating men with active vs. stable disease, suggesting that ongoing pain is not a contraindication to CCH therapy.