036 A Trial of Low-Intensity Shockwave Therapy for Penile Rehabilitation After Radical Prostatectomy

Abstract

Erectile dysfunction (ED) is a common complication of radical prostatectomy, usually due to nerve damage. Low-intensity shockwave therapy (LISWT) is an encouraging new treatment for men with vasculogenic ED, but the role of LISWT in the post-prostatectomy setting is unknown, as existing LISWT trials excluded men who underwent prostatectomy. Interestingly, rat models of cavernosal nerve injury suggest LISWT may restore penile blood flow via revascularization and neuronal regeneration. We hypothesize that LISWT-based penile rehabilitation will accelerate recovery of erectile function following nerve-sparing radical prostatectomy. To evaluate the hypothesis that PDE5i therapy combined with LISWT, delivered early in the post-prostatectomy period, will lead to more rapid recovery of erectile function compared to men treated with PDE5i alone. This is an interim analysis of an IRB approved, non-randomized trial of LISWT for penile rehabilitation. Patients were identified for inclusion if their pre-operative sexual health inventory for men (SHIM) score was ≥ 17 and they underwent a bilateral nerve-sparing prostatectomy at our academic referral hospital. Exclusion criteria included: concurrent use of intracavernosal injections or vacuum erectile device; or Gleason Grade Group ≥ 4 disease. Men were enrolled in either the LISWT arm (intervention) or the PDE5i only arm (control) at their own discretion. Beginning two weeks post-operatively, intervention patients received six consecutive LISWT sessions delivered once weekly using the Zimmer enPuls 2.0 device. During each session, settings were 90 mJ and 15 Hz to deliver a total of 10,000 “shocks” distributed to the corpora and cavernosal neurovascular bundles bilaterally. SHIM and erection hardness score (EHS) surveys were mailed to both cohorts at 6, 12, and 24-weeks post-operatively. All patients were prescribed a PDE5i at the discretion of their treating surgeon.