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Introduction

Low-Intensity Shockwave Lithotripsy (LISWT) may improve erectile function in patients with mild to moderate erectile dysfunction (ED). Currently there remains a paucity of research and prospective data on the utilization of LISWT in patients whom experience ED.

Objectives

The purpose of this Phase I clinical trial is to evaluate the safety and potential efficacy of this novel therapy. We present our Results with an initial cohort of patients.

Methods

We obtained IRB approval and prospectively enrolled patients (n=17) with mild to moderate ED. Treatment consisted of the application of 3300 shocks (0.16mJ/mm2) each to the bilateral corpora cavernosa and the bilateral crura. Full treatment course included six weekly treatment sessions and a one-month post-treatment evaluation. IIEF and EDITS scores were obtained at baseline and one month after the treatment course concluded, along with GAQ and erectile hardness questionnaires. Duplex penile ultrasound assessed peak systolic velocity (PSV) of the cavernosal arteries at baseline and one-month post-treatment. Statistically significant differences in IIEF, EDITS and PSV pre and post-treatment were evaluated using Wilcoxon signed-ranks test, while categorical metrics were evaluated using logistic regression. Clinically-significant differences for IIEF-6 scores were defined by an increase of 2, 5, or 7 points based on baseline mild (>17), moderate (>8), or severe (<8) scores, respectively, while clinically-significant differences for EDITS was defined as an increase >9 points from initial to final score.

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