(303) Low-Intensity Extracorporeal Shock Wave Therapy for Erectile Dysfunction: A Comprehensive Systematic Review and Meta-Analysis

Introduction Erectile dysfunction (ED) is common and can strongly affect men's well-being. While phosphodiesterase type 5 inhibitors (PDE-5i) offer effective symptomatic relief, they do not restore natural erectile function for all patients. Low-intensity extracorporeal shock wave therapy (LI-ESWT) has been proposed as a regenerative option, but its comparative efficacy remains unclear. Objective To comprehensively evaluate the efficacy of LI-ESWT for ED through multiple direct comparisons: LI-ESWT versus sham treatment, LI-ESWT versus PDE-5i monotherapy, combination therapy (LI-ESWT plus PDE-5i) versus PDE-5i monotherapy, and combination therapy versus LI-ESWT monotherapy, with subgroup analyses in vasculogenic ED and PDE-5i non-responders. Methods A systematic review and network meta-analysis were conducted following PRISMA guidelines. PubMed, Web of Science, Scopus, and the Cochrane Library were systematically searched through May 2025 for randomized controlled trials evaluating LI-ESWT in men with ED. Included studies compared LI-ESWT monotherapy versus sham, LI-ESWT versus PDE-5i, LI-ESWT plus PDE-5i versus PDE-5i alone, and LI-ESWT plus PDE-5i versus LI-ESWT alone. Primary outcomes were changes in International Index of Erectile Function-5 (IIEF-5) and Erection Hardness Score (EHS) assessed at 1-, 3-, 6-, and 12-month follow-up. Random-effects models calculated pooled mean differences with 95% confidence intervals. Heterogeneity was quantified using I^2 statistics, and subgroup analyses examined vasculogenic etiology and PDE-5i non-responder populations. Results Twenty-two randomized controlled trials were included. LI-ESWT demonstrated significant superiority over sham treatment across all timepoints for IIEF-5 (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; 6 months: MD=3.51, 95% CI 1.17–5.85, p=0.003). When compared directly with PDE-5i monotherapy, PDE-5i showed superior short-term efficacy at 1 month (MD=-2.75, 95% CI -4.34 to -1.16, p=0.0007), but by 3 months, no significant difference existed between treatments (MD=-0.09, 95% CI -1.71 to 1.54, p=0.92). Combination therapy (LI-ESWT plus PDE-5i) provided significantly greater IIEF-5 improvement versus LI-ESWT alone at 1, 3, and 6 months (p<0.001), but not at 12 months (p=0.35). However, adding LI-ESWT to PDE-5i in patients already on PDE-5i showed no additional benefit at 1 month (MD=1.86, 95% CI -1.93 to 5.65, p=0.34). In vasculogenic ED specifically, LI-ESWT monotherapy significantly outperformed sham at both 1 and 3 months, while combination therapy offered no advantage over PDE-5i alone. Notably, LI-ESWT demonstrated significant efficacy in PDE-5i non-responders compared with continued sham plus PDE-5i treatment (1 month: MD=3.63, 95% CI 1.02–6.24, p=0.006; 3 months: MD=3.21, 95% CI 2.94–3.50, p<0.001). Conclusions LI-ESWT is an effective regenerative treatment for erectile dysfunction. It is superior to sham, matches PDE-5i effectiveness by 3 months, and helps patients unresponsive to PDE-5i. Combined therapy gives short-term benefits but no long-term advantage. LI-ESWT should be considered for both treatment-naïve and PDE-5i-refractory patients, while further research is needed to optimize protocols and candidate selection. Disclosure No