Erectile dysfunction (ED) is a common condition affecting men, characterized by the inability to achieve or maintain an erection. Low-intensity extracorporeal shockwave therapy (LI-ESWT) has emerged as a potential treatment for ED due to its regenerative effects. However, despite some promising evidence, the quality of the supporting studies is low. This study aims to synthesize the available evidence from randomized controlled trials (RCTs) to optimize therapeutic parameters for LI-ESWT in ED.

Adhering to PRISMA 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.

Out of the studies reviewed, 19 RCTs met the inclusion criteria. LI-ESWT significantly improved erectile function at 1-month, 3-month, and 6-month follow-ups, with improvements in International Index of Erectile Function (IIEF). Subgroup analyses revealed that LI-ESWT was beneficial for patients across all levels of ED severity. Meta-regression analyses indicated that treatment frequency and pulse number per course played a role in the therapy’s success. The results proposed an optimal therapeutic regimen involving 3000 pulses per session administered twice per week.

LI-ESWT is a promising non-invasive and regenerative treatment for ED with significant improvements in IIEF across all disease severity lasting at least six months. Current evidence indicates that a regimen involving 3000 pulses per session, administered twice weekly, may yield the most favorable clinical outcomes.