Comparison of the effectiveness of 2 shockwave therapy protocols for the treatment of vascular erectile dysfunction: a randomized, multicenter, open-label, noninferiority, phase 4 clinical trial

Abstract Background Shockwave therapy is an optional adjuvant treatment for vascular erectile dysfunction (ED). There is variability in treatment protocols and challenges with patients adherence to the weekly protocol, which is the most commonly used. Aim This study aimed to evaluate the noninferiority of a monthly shockwave therapy protocol compared to the weekly protocol for treating vascular ED. Methods A randomized, open-label, control active, multicenter clinical trial was conducted. A total of 184 men diagnosed with vascular ED, without comorbid conditions associated with secondary dysfunction or active treatment for ED, were included across 5 clinics in Mexico and Colombia. Patients were randomized to receive either 6 sessions of weekly or monthly shockwave therapy, applying the same parameters for both groups. Outcomes The primary outcome was the change in the International Index of Erectile Function-Erectile Function Domain (IIEF-EF) Questionnaire score at 24 weeks after treatment, assessed using a noninferiority approach. Secondary outcomes included clinical improvement, erection hardness, and self-esteem (SEAR Questionnaire) at posttreatment, 12 weeks, and 24 weeks of follow-up. Results At 24-week posttreatment, the average change in IIEF-EF was 1.93 (± 6.55; 95% CI 0.49-3.38) in the weekly group and 4.30 (± 6.78; 95% CI 2.69-5.9) in the monthly group, demonstrating noninferiority of the monthly protocol (difference −2.36; 95% CI −4.4 to −0.2; noninferiority P < .0001). At the end of treatment, clinical improvement was achieved by 55.2% of participants in the monthly protocol and 30.9% in the weekly (P = .042). No significant differences were found in other outcomes. Clinical Implications A 6-session monthly shockwave therapy regimen could improve erectile function in men with ED. Strengths and Limitations This is the largest clinical trial to date evaluating shockwave therapy regimens for ED. The principal limitations were the absence of objective vascular assessment of the changes produced by shockwaves, and the absence of a placebo control group. Conclusion A monthly protocol of 6 shockwave therapy sessions is noninferior to a weekly protocol up to 6 months after therapy, in men with vascular ED.