165 Impact of Penile Traction Therapy on Erectile Dysfunction in a Cohort of Men with Peyronie's Disease

Abstract

Several studies have previously demonstrated improvements in erectile function among Peyronie’s disease (PD) men undergoing penile traction therapy (PTT). However, to date, no randomized controlled trials have confirmed this finding or attempted to differentiate the changes in erectile function from improvements in curvature. To identify the impact of PTT on erectile function, independent of improvements in penile curvature or length in a PD cohort. 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 and non-standardized questionnaires. Assessments are obtained at baseline and 3 and 6 months after starting therapy. To specifically evaluate erectile function, patients were administered the International Index of Erectile Function Questionnaire and SEP2 and SEP3. Additionally, given the difficulty in differentiating improvements in erectile function from changes in PD, patients were asked the non-standardized question, “has the treatment you have been taking improved your erectile function?”