Abstract Introduction Erectile dysfunction (ED) is a prevalent condition that significantly affects quality of life, with current treatments focused mainly on symptom management rather than restoration of erectile function. Low-intensity extracorporeal shock wave therapy (LI-ESWT) has emerged as a potential regenerative treatment aimed at improving penile hemodynamics through neovascularization, yet its clinical efficacy remains debated. Objective To compare the effects of LI-ESWT versus sham treatment on erectile function in men with ED, assessed by changes in the International Index of Erectile Function-5 (IIEF-5) and Erection Hardness Score (EHS). Methods A systematic review and meta-analysis were performed following PRISMA guidelines. Databases including PubMed, Web of Science, Scopus, and the Cochrane Library were searched through May 2025 for randomized controlled trials comparing ESWT with sham treatment in men with ED. The primary outcome was change in IIEF-5 score, while secondary outcomes included change in EHS at 1-, 3-, and 6-month follow-up. Results Nine RCTs were included. ESWT significantly improved IIEF-5 scores compared with sham at 1 month (MD = 1.89, 95% CI 0.40–3.39; p = 0.01), 3 months (MD = 2.24, 95% CI 0.96–3.52; p 0.001), and 6 months (MD = 3.51, 95% CI 1.17–5.85; p = 0.003), with low-to-moderate heterogeneity (I2 = 0–45%). For EHS, ESWT showed higher values than sham at both 1 month (MD = 0.53, 95% CI 0.01–1.05; p = 0.05) and 3 months (MD = 0.48, 95% CI –0.12–1.07; p = 0.12), though without reaching statistical significance. No subgroup differences were observed across time points (p 0.05). Conclusions This meta-analysis demonstrates that LI-ESWT significantly improves erectile function as measured by IIEF-5, with effects sustained for up to 6 months, while EHS shows only a slight improvement. These findings support ESWT as a safe and effective non-invasive option for men with mild to moderate ED. However, further studies are warranted to define optimal treatment protocols and long-term outcomes. Disclosure No
Abdelshafi et al. (Mon,) studied this question.
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