Abstract: PD69-04
Sources of Funding: None.

Introduction

To evaluate the safety and efficacy of Low-intensity Extracorporeal Shockwave (LI-ESWT) in the Treatment of Vasculogenic Erectile Dysfunction.

Methods

A multi-center, double-blind, randomized sham-controlled clinical trial was conducted. 70 patients (46 cases for LI-ESWT treatment group and 24 cases for the placebo group) at age 20-70 years, who had mild or moderate Vasculogenic ED evaluated with the International Index of Erectile Function erectile function domain (IIEF-EF) were recruited for this study. Screening, treatment and results were performed in sequence. 4 weekly sessions for the treatment stage: A total of 5000 shockwaves were applied for each treatment and 4 areas were conducted including: 900 shockwaves in right and left crura, and 1600 shockwaves in each site. Effectiveness was assessed according to the International Index of Erectile Function erectile function domain (IIEF-EF), questions 2 and 3 of the Sexual Encounter Profile (SEP), Global Assessment Question (GAQ) scores, and Erection Hardness Scale (EHS) at baseline and at 1 and 3 months after treatment. The study was approved by Peking University First Hospital ethics committee, and all patients signed an informed consent form.

Results

For Full Analysis Set (FAS) and Per-Protocol Set (PPS), the average IIEF-EF increased significantly from 18.04±3.94 (17.90±3.77) at baseline to 22.02±4.13 (21.95±4.06) at 1 months post treatment, and was 22.54±3.98 (22.49±3.90) at the 3 months follow-up. The success rate by LI-ESWT is 67.39% (73.17%) after 1months post treatment VS 20.83% (23.81%) in the placebo group and is 69.57% (73.17%) after 3 months post treatment VS 20.83% (23.81%) in the placebo group by FAS (PPS). SEP, GAQ, EHS analysis were also significantly improved compared to the placebo controls (p<0.05). No side effects were reported in this study. _x000D_ _x000D_

Conclusions

LI-ESWT in patients with mild or moderate Vasculogenic ED is a feasible, noninvasive and effective way for improving male ED.

Funding

None.