Abstract: PD31-06
Sources of Funding: Funding support provided by Endo Pharmaceuticals Inc.

Introduction

To evaluate collagenase clostridium histolyticum (CCH) injection with vacuum therapy for treatment of Peyronie's disease (PD).

Methods

In this open-label study, patients with PD were stratified by penile curvature degree and randomized 1:1 to CCH plus vacuum therapy with or without modeling. Each treatment cycle consisted of 2 CCH injections (0.58 mg, separated by 24-72 hours) and twice-daily vacuum therapy (initiated ~2 weeks after second CCH injection in a given cycle). Modeling was performed 24-72 hours after last CCH injection of each treatment cycle. Patients who did not achieve penile curvature less than 15 degrees by ~6 weeks after previous cycle received up to 4 cycles. Penile curvature and the Peyronie's Disease Questionnaire (PDQ) were assessed.

Results

Each group included 15 patients. Penile contusion (86.7% and 100.0% in the CCH plus vacuum plus modeling and the CCH plus vacuum group, respectively), penile swelling (73.3% and 100.0%), and penile pain (53.3% and 33.3%) were the most frequent adverse events. All were mild, local, and transient. No incidences of corporal rupture or penile fracture were reported. Penile curvature at baseline was similar between treatment groups (mean [SD], 59.0 degrees [15.0] and 58.3 degrees [12.2] for the CCH plus vacuum plus modeling and CCH plus vacuum only group, respectively). At week 36, mean improvement in penile curvature was similar in both groups (mean change [SD]; CCH plus vacuum plus modeling, 23.7 degrees [10.9] or 39.3% [13.2%]; CCH plus vacuum only, 23.3 degrees [7.2] or 41.1% [11.5%]; difference, 0.3 degrees [95% CI: -7.3, 6.6] and 1.8% [95% CI: -7.5%, 11.0%]). Mean (SD) improvement in the PDQ bother score at week 36 was similar in the CCH plus vacuum plus modeling (2.4 [2.5]) and the CCH plus vacuum only (3.8 [3.0]) groups (difference, 1.4 [95% CI: -0.9, 3.8]). Results were similar for other secondary efficacy endpoints.

Conclusions

CCH plus vacuum therapy with and without modeling improved penile curvature in patients with PD with report of mild local adverse events.

Funding

Funding support provided by Endo Pharmaceuticals Inc.