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June 6, 2026

(839) Efficacy of Low-Intensity Extracorporeal Shock Wave Therapy Versus PDE-5i for Erectile Dysfunction: A Systematic Review and Meta-Analysis

Key Points

The study aims to compare the efficacy of LI-ESWT monotherapy versus PDE-5i monotherapy in treating erectile dysfunction.
Systematic review and meta-analysis following PRISMA guidelines.
Included randomized controlled trials comparing LI-ESWT against PDE-5i in men with erectile dysfunction.
Primary outcomes were changes in IIEF-5 and EHS scores, analyzed at 1 month and 3 months follow-up.
At 1 month, PDE-5i showed superior IIEF-5 improvement (MD: -2.75; 95% CI [-4.34, -1.16]; p=0.0007).
By 3 months, no significant difference was observed in IIEF-5 between treatments (MD: -0.09; 95% CI [-1.71, 1.54]; p=0.92).
EHS results followed a similar trend with PDE-5i better at 1 month (MD: -0.48; 95% CI [-0.92, -0.04]; p=0.03), but no difference by 3 months (MD: -0.14; 95% CI [-0.38, 0.10]; p=0.26).

Abstract

Abstract Introduction Erectile dysfunction (ED) is a prevalent condition significantly impacts quality of life. Phosphodiesterase type 5 inhibitors (PDE-5i) are the first-line, on-demand treatment for relief. Low-Intensity Extracorporeal Shock Wave Therapy (LI-ESWT) is a new, non-invasive option with potential restorative effects. Comparing their efficacy, especially onset and duration, is important for clinical decisions. However, robust meta-analytical data from direct trials remain scarce limited. Objective To compare the efficacy of LI-ESWT monotherapy versus PDE-5i monotherapy for the treatment of ED, assessed by changes in the International Index of Erectile Function-5 (IIEF-5) and the 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. We included randomized controlled trials that directly compared LI-ESWT monotherapy against PDE-5i monotherapy in men with ED. The primary outcomes analyzed were the mean difference (MD) in the International Index of Erectile Function-5 (IIEF-5) score and Erection Hardness Score (EHS). Subgroup analyses were performed based on the follow-up time points of 1 month and 3 months. Random-effects models were used to calculate pooled mean differences (MD) with 95% confidence intervals (CI) and statistical significance was set at p0.05. Results three RCTs were included in the meta-analysis. For the IIEF-5 score, the pooled analysis demonstrated a statistically significant superiority for the PDE-5i group at the 1-month follow-up (MD: -2.75; 95% CI -4.34, -1.16; p=0.0007). This analysis showed low heterogeneity (I2=0%). However, by the 3-month follow-up, this difference was no longer observed, with no statistically significant variation between the LI-ESWT and PDE-5i groups (MD: -0.09; 95% CI -1.71, 1.54; p=0.92; I2=23%). A similar pattern was observed for the Erection Hardness Score (EHS). At 1 month, the PDE-5i group showed a significantly greater improvement in EHS (MD: -0.48; 95% CI -0.92, -0.04; p=0.03), though this analysis was marked by high heterogeneity (I2=76%). By 3 months, there was no significant difference in EHS between the two treatment arms (MD: -0.14; 95% CI -0.38, 0.10; p=0.26; I2=0%). Conclusions This meta-analysis shows a time-dependent difference in LI-ESWT and PDE-5i efficacy. PDE-5i give faster, superior short-term improvements in erectile function (IIEF-5) and erection hardness (EHS) at 1 month. Yet, this advantage diminishes over time, and by 3 months, LI-ESWT has similar efficacy. While PDE-5i deliver quick results, LI-ESWT offers a viable alternative with a slower onset, reaching comparable outcomes later. The high heterogeneity in 1-month EHS data calls for cautious interpretation and more standardized trials. Disclosure No

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