A Prospective, Randomized, Double-Blinded, Clinical Trial Using a Second-Generation Duolith SD1 Low-Intensity Shockwave Machine in Males with Vascular Erectile Dysfunction

Purpose: To evaluate the clinical efficacy and patient satisfaction rates of low-intensity extracorporeal shockwave therapy LIESWT) in men with vasculogenic erectile dysfunction (ED) using Duolith SD1 machine. Materials and Methods: This prospective, randomized, double-blinded clinical trial included 60 men who were randomly assigned to LIESWT (n=30, active group) or placebo (n=30) over 6 weeks. Patient demographics, change in International Index of Erectile Function (IIEF)-5, Erection Hardness Score (EHS) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, and an overall satisfaction score (on a 5-point scale), were recorded. All patients were reviewed at 1, 3, and 6 months after completion of therapy. Results: There were 21 (70%) patients in the LIESWT group and 3 (10%) patients in the placebo group who had a 5-point or greater increase in IIEF-5 score (p=0.018). At 6-month study period, the mean IIEF-5 score was 18.8 (standard deviation [SD], 3.8) in the LIESWT group versus 14.8 (SD, 3.6) in the placebo group, difference in means between groups was 4.0 (95% confidence interval, 2.1-5.9; p<0.001). The EHS scores were higher in the LIESWT group with a mean of greater than 1.2 across the 1, 3, and 6 months compared to the placebo group (p<0.05). All patients completed the treatment study and there was no adverse event reported in terms of penile pain, bruising or deformity. There was a positive correlation between men who reported improvement in EF and treatment satisfaction level with LiESWT (p=0.008). Conclusions: LIESWT improves erectile function in the short-term especially in men with mild to moderate ED, and those without a cardiometabolic disease.