MP65-18 PRELIMINARY OUTCOMES OF A NOVEL PENILE TRACTION DEVICE (RESTOREX) IN MEN WITH PEYRONIE’S DISEASE: A RANDOMIZED, CONTROLLED TRIAL

Abstract

INTRODUCTION AND OBJECTIVES: Penile traction therapy (PTT) is a common treatment used in the management of Peyronie's disease (PD). However, existing PTT devices require daily utilization for >5 hours and data regarding penile curvature and length improvements are inconsistent and of unclear clinical benefit. Given these limitations, a novel PTT device, RestoreX, was developed specifically as a primary or adjunctive therapy for PD. Here, we sought to assess the safety and efficacy of the RestoreX PTT device in men with PD. METHODS: A randomized, controlled trial (NCT03389854) is ongoing to evaluate the impact of PTT with RestoreX in 120 men with PD. Men are randomized to one of four groupings: no therapy (control) or treatment with Restorex for 30 minutes 1x, 2x, or 3x daily for 3 months. All men then enter an open label phase for an additional 3 months. Inclusion criteria are no current or recent PD therapies and >30 degrees curvature. The primary outcome is safety, and secondary outcomes include penile length, curvature, and subjective responses to standardized (IIEF, PDQ) and non‐standardized questionnaires. Assessments are obtained at baseline and 3 and 6 months after starting therapy. RESULTS: A total of 117 men have been enrolled to date, with 3‐month data available on 85 patients (control, n = 19, PTT, n=66). Baseline clinicopathologic characteristics include a mean age of 58.4 (SD 7.8) years, mean PD duration 45.0 (42.0) months, mean primary curvature 45.7 (11.7) degrees, and mean stretched penile to coronal length of 11.5 (1.4) cm, all non‐significant between PTT and controls. After 3 months of treatment, PTT significantly improved penile length (+1.4 cm [+9.9%] vs +0.3 cm =2.1%], p<0.01), and primary penile curvature (‐9 degrees [‐18.9%] vs ‐1.0 degrees [‐2.4%], p<0.01) compared to controls. Results from the PD Questionnaire demonstrated significant improvements in the psychological/physical domain (PTT ‐2.6 vs ‐0.5, p=0.01). Of those who could not penetrate at baseline, 38% reported restored ability to penetrate (vs 0%, p<0.01), and 19% indicated that therapy negated a need for surgery. Adverse events with PTT were all mild and resolved within 5 minutes of completing therapy: mild discomfort (44%), erythema (39%), and sensory changes (15%). CONCLUSIONS: Based on preliminary results, in a cohort of PD men, PTT with RestoreX for 30‐90 minutes daily resulted in statistically significant improvements in penile length and curvature at 3 months compared to controls with no significant adverse events.