(060) DOES THE TYPE OF SHOCKWAVE GENERATOR MATTER? A SYSTEMATIC REVIEW AND BAYESIAN NETWORK META-ANALYSIS ASSESSING RANDOMIZED SHAM CONTROLLED TRIALS USING FOCUSED SHOCKWAVE LITHOTRIPSY FOR MODERATE ERECTILE DYSFUNCTION
Authors: Kohn T , Lipshultz L 
Published: December 2024

Introduction

Focused low-intensity shockwave therapy (LiSWT) has been demonstrated to improve erectile function in some randomized controlled trials (RCTs). However, significant heterogeneity exists when comparing RCTs for LiSWT as shockwaves can be generated via three methods: electromagnetic, electrohydraulic, and piezoelectric generators. No study has directly assessed whether the type of LiSWT generator impacts clinical outcomes for erectile dysfunction.

Objective

The objective of this study is to perform a network meta-analysis to compare the effect of different LiSWT generators on change in IIEF scores for men with moderate erectile dysfunction.

Methods

A systematic review of MEDLINE, EMBASE, Cochrane Library, and ClinicalTrials.gov was performed for randomized sham-controlled trials from database inception through June 2024. Studies were included if they evaluated changes in international index of erectile function (IIEF) scores in men with moderate erectile dysfunction (baseline IIEF-5: 8-11 or baseline IIEF-EF: 11-16) at either 1 month or at 3-6 months follow-up. Studies were not included if they assessed erectile dysfunction after prostatectomy. The analysis was limited to studies with a baseline of moderate erectile dysfunction as this is the most studied population and limits heterogeneity by focusing on a single severity cohort. Randomized sham-controlled trial data for piezoelectric, electromagnetic, and electrohydraulic LiSWT devices were pooled via network meta-analysis with random effect modeling.

Results

A total of 16 RCTs were identified with 1036 men included. 6 studies report changes in IIEF scores only at 1 month, 3 studies at both 1 month and 3-6 months, and 7 studies only at 3-6 months. After 1 month, the mean difference from baseline between treatment and sham group found that electrohydraulic had the greatest improvement in IIEF score (mean difference between treatment and sham therapy from baseline: 5.19, 95% Confidence Interval 2.08-8.29, number of studies = 5), while electromagnetic also had significant improvement from baseline when comparing treatment versus sham (MD: 3.72, 95% CI 3.36-4.07, n = 2), piezoelectric did not significantly improve IIEF scores when comparing treatment vs sham (MD: 0.34, 95% CI -4.72-5.39, n = 2) (Fig. 1). After 3-6 month, the mean difference from baseline between the treatment and sham group for electromagnetic was significant (MD: 5.15, 95% CI 3.90-6.40, n = 5) while piezoelectric generators did not see an improvement between therapy and sham from baseline (MD: 2.08, 95% CI -1.28-5.43, n = 4). Only 1 study assessed electrohydraulic generators at the 3-6 month interval (MD: 3.68, 95% CI 3.07-4.29).

Conclusions

Piezoelectric generators for LiSWT do not significantly improve IIEF scores at 1 or 3-6 months for men with moderate erectile function while electromagnetic generators appear to have significant improvement in IIEF scores in this same population at both 1 and 3-6 months. While electrohydraulic appears to significantly improve IIEF scores at 1 month, more studies are needed to assess the long-term impact of these LiSWT generators on erectile function.

Disclosure

No.