A Prospective Randomized Study on Low-Energy Extracorporeal Shockwave Therapy for Erectile Dysfunction After Radical Prostatectomy.

PURPOSE To evaluate the efficacy of low-energy extracorporeal shockwave therapy (LI-SWT) compared with a sham treatment in improving erectile function in men after radical prostatectomy. Erectile function was assessed using the Erection Hardness Score (EHS) and International Index of Erectile Function (IIEF) at baseline and 4, 12, and 24 weeks after treatment. MATERIALS AND METHODS A total of 75 participants were randomized to either LI-SWT or sham treatment. Data were analyzed using a zero-inflated negative binomial model for IIEF scores and appropriate nonparametric methods for the ordinal EHS data, including binary transformation for clinically relevant outcomes. RESULTS The zero-inflated model for IIEF scores showed no significant difference between treatment groups with a ratio of 1.2 (95% CI: 0.1-2.4, P  =  .469). At 24 weeks post-treatment, the estimated median IIEF score was 4 in the LI-SWT group compared with 4 in the sham group. For EHS, no significant treatment effect was found, with median scores at 24 weeks of 2 in the LI-SWT group vs 2 in the sham group. The proportion of patients achieving sufficient erection hardness (EHS ≥3) at 24 weeks was 18% (95% CI: 9%-34%) in the LI-SWT group vs 26% (95% CI: 14%-43%) in the sham group (P = .552). CONCLUSIONS This study did not demonstrate a statistically significant improvement in erectile function for men undergoing LI-SWT compared with sham treatment after radical prostatectomy.