Abstract

INTRODUCTION AND OBJECTIVE: Several studies have demonstrated favorable results for the use of Low-intensity Shockwave Therapy (Li-SWT) for the treatment of erectile dysfunction (ED). Despite several studies demonstrating efficacy, no clinical trial from the USA has been published in the peer-reviewed literature. We hypothesized that Li-SWT is safe and can be used to treat men with mild to moderate ED. METHODS: We performed a single–institution, open-label, two-arm, phase II clinical trial, conducted between February 2017 and March 2018 with primary end points of safety and dose estimation. Intervention included Li-SWT delivering 3600 shocks over 5 days (720 once a day, Group A) or over 2 weeks (600, 3 times a week, Group B). Patients completed the International Index of Erectile Function Erectile Function domain (IIEF-EF) and the Erectile Hardness Scale (EHS) at baseline, and at 1, 3, and 6 months’ visits. Improvement in IIEF-EF and EHS scores, and clinical response, defined as the proportion of participants achieving minimal clinically important difference (MCID) defined as an increase in IIEF-EF of ≥2 for patients with baseline mild ED (IIEF-EF scores 17-25) and ≥5 for patients with baseline moderate ED (IIEF-EF scores 11-16) in IIEF-EF at 6 months, were compared between groups. RESULTS: A total of 87 men were randomized with 45 and 42 in groups A and B, respectively. No adverse outcomes were reported during treatment nor during follow-up; and 80 patients completed the 6-month evaluation (40 in each group). Overall, 57.5% and 47.5% of patients for Group A and Group B, respectively, reached MCID in IIEF-EF at 6 months. There were statistically significant (p<0.05) improvements in IIEF-EF score (mean increase of 2.7 points (95% CI: 1.2, 4.2) and 2.7, 95% CI: 1.4, 4.1) for groups A and B, respectively) and in EHS (mean increase of 0.6 points (95% CI: 0.3, 0.8) and 0.5 (95% CI: 0.2, 0.8) for Groups A and B, respectively) at 6 months, with no differences between groups. CONCLUSIONS: Li-SWT appears to be safe for the treatment of ED. Our results corroborate prior randomized controlled trials which demonstrate favorable improvement in IIEF-EF and EHS scores. Future randomized trials with sham treatment will need to be performed to demonstrate true efficacy of Li-SWT for ED. Source of Funding: Supported by Barton Weiss Mens Health Initiative and device was provided by Direx Inc.

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