Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial

Abstract

ABSTRACT Introduction Radial wave therapy is commercialized as an option for the management of erectile dysfunction. However, the mechanism of action of the radial waves differs substantially from shock waves, so the evidence gathered for shock wave therapy cannot be extrapolated, and there are very few clinical trials with the radial wave. Aim To assess the efficacy and safety of radial wave therapy compared with sham therapy for the treatment of moderate and mild to moderate erectile dysfunction. Methods A randomized, double-blind, sham-controlled clinical trial was realized. Eighty patients with moderate erectile dysfunction, without sickle cell anemia, anticoagulation treatment, comorbidities, or conditions associated with secondary erectile dysfunction were included. The efficacy and safety were assessed at 6 and 10 weeks after randomization. Patients were randomized 1:1 to 1 of 2 arms: (i) 6 weekly sessions of radial wave therapy (RW group) or (ii) 6 weekly sessions of sham therapy (control group). All patients received sildenafil 25 mg. Outcome The primary outcome was the mean change in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain score at 6 weeks after randomization. Results Eighty men were randomized. The average baseline IIEF-EF score was 16.3 (Standard Deviation - SD 3.2), and the median baseline Erection Hardness Score (EHS) was 3 (IQR 1). At 6 weeks after randomization, the mean change in the IIEF-EF score was 3.4 (95% confidence interval [CI] 1.5-5.2) in the RW group and 4.2 (95% CI 2.5-5.9) in the control group. No differences were observed between groups (P value =.742). No change was observed in the median EHS score in the evaluations. No serious adverse events occurred in 2 (5%) patients after radial wave therapy, and in 1 (2.5%) patient after sham therapy. Clinical Implications Knowledge of the effectiveness of radial waves protocols used for the treatment of moderate erectile dysfunction, helps doctors and patients in making decisions about the use of this therapy. Strengths & Limitations One strength is conducting the study with high methodological standards to minimize risk biases. Our results are limited to the evaluation of 1 specific protocol in moderate and mild to moderate erectile dysfunction. Conclusions No difference was found in this study between men with moderate and mild to moderate erectile dysfunction treated with radial waves and men treated with placebo sham therapy. Studies with different protocols of radial waves are necessary.