Effect of Low-Energy Linear Shockwave Therapy on Erectile Dysfunction—A Double-Blinded, Sham-Controlled, Randomized Clinical Trial

Introduction Previous studies have shown that focal low-energy extracorporeal shockwave therapy (Li-ESWT) can have a positive effect in men with erectile dysfunction (ED). Linear Li-ESWT (LLi-ESWT) for ED has not been previously assessed in a randomized trial. Aim To evaluate the treatment outcome of LLi-ESWT for ED. Methods Men with ED (n = 126) and a score lower than 25 points on the International Index of Erectile Function erectile function domain (IIEF-EF) were included. Subjects were allocated to receive LLi-ESWT once a week for 5 weeks or sham treatment once a week for 5 weeks. After a 4-week break, the two groups received active treatment once a week for 5 weeks. Subjects completed the IIEF, Erection Hardness Scale (EHS), Sexual Quality of Life–Men, and the Erectile Dysfunction Inventory of Treatment Satisfaction at baseline, after 9 weeks, and after 18 weeks. Main Outcome Measures The primary outcome measurement was an increase of at least five points on the IIEF-EF score. The secondary outcome measurement was an increased EHS score to at least 3 in men with a score no higher than 2 at baseline. Data were analyzed by linear and logistic regression. Results Mean IIEF-EF scores were 11.5 at baseline (95% CI = 9.8–13.2), 13.0 after five sessions (95% CI = 11.0–15.0), and 12.6 after 10 sessions (95% CI = 11.0–14.2) in the sham group and correspondingly 10.9 (95% CI = 9.1–12.7), 13.1 (95% CI = 9.3–13.4), and 11.8 (95% CI = 10.1–13.4) in the ESWT group. Success rates based on IIEF-EF score were 38.3% in the sham group and 37.9% in the ESWT group (odds ratio = 0.95, 95% CI = 0.45–2.02, P = .902). Success rates based on EHS score were 6.7% in the sham group and 3.5% in the ESWT group (odds ratio = 0.44, 95% CI = 0.08–2.61, P = .369). A limitation of this study is that device settings (number of shockwaves and penetration depth) were estimated based on an existing trial on focused ESWT. Conclusion No clinically relevant effect of LLi-ESWT on ED was found.