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

Abstract

IntroductionPrevious 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. AimTo evaluate the treatment outcome of LLi-ESWT for ED. MethodsMen 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 MeasuresThe 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. ResultsMean 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. ConclusionNo clinically relevant effect of LLi-ESWT on ED was found.