Abstract Introduction Erectile dysfunction (ED), defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is a prevalent condition among men and has a significant impact on quality of life. Among the emerging therapeutic options, low-intensity extracorporeal shockwave therapy (LI-ESWT) has gained attention due to its proposed regenerative effects. Despite a growing number of studies suggesting the efficacy of LI-ESWT, the overall quality of the evidence remains limited, with heterogeneity in treatment protocols and study designs. Objectives This study aims to synthesize the available evidence from randomized controlled trials (RCTs) to identify and evaluate the therapeutic parameters associated with optimal outcomes of LI-ESWT in the treatment of ED. By clarifying treatment protocols, this review seeks to provide guidance for clinical practice and inform future research design. Methods Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, the study protocol was registered with PROSPERO (CRD42024581988). Searches were conducted in PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov up to October 30, 2024, to evaluate the efficacy of the therapy. Risk of bias was evaluated using the Cochrane risk-of-bias tool (version 2, RoB 2) for the included RCTs. As for the heterogeneity across the RCTs, subgroup and meta-regression analyses were conducted to mitigate heterogeneity and identify the most effective treatment protocols. Results Nineteen RCTs met our inclusion criteria. The majority of included studies exhibited important methodological limitations, most notably the limited use of the International Index of Erectile Function erectile function domain (IIEF-EF; 6 items) as the standardized outcome measure. Pooled analyses demonstrated that LI-ESWT significantly improved erectile function at 1-month, 3-month, and 6-month follow-ups, with statistically significant improvements in IIEF. However, confidence in long-term effects was reduced due to the limited number of studies reporting 6-month outcomes. Meta-regression analyses indicated that treatment frequency and pulse number per course were associated with therapeutic response. Conclusions Although several RCTs demonstrated statistically significant improvements in erectile function following LI-ESWT, the majority of studies failed to achieve the minimally clinically important difference. Therefore, based on the currently available evidence, it remains unclear whether LI-ESWT provides a clinically meaningful benefit for ED at the present time. No definitive conclusions can be drawn regarding the superiority of any specific treatment regimen.
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