Effect of Low-Energy Linear Shockwave Therapy on Erectile Dysfunction-A Double-Blinded, Sham-Controlled, Randomized Clinical Trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 126 participants or records.
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