The Use of Energy-Based Devices for the Treatment of Stress Urinary Incontinence: A Systematic Review and Meta Analysis of the Randomised Sham-Controlled Trials

Abstract Introduction and Hypothesis Energy-based devices (EBDs), including vaginal laser and radiofrequency therapies, have been proposed as minimally invasive treatments for stress urinary incontinence (SUI), but evidence remains limited and inconsistent. We hypothesised that EBDs would provide greater symptom improvement than sham, particularly in women with mild to moderate SUI. Methods Following PRISMA guidelines, we searched Medline, Embase, the Cochrane Library, and One Search for randomised controlled trials (RCTs) comparing EBDs with sham in women with SUI, with at least 1 month of follow-up. The primary outcome was change in International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF) scores. Two reviewers independently performed data extraction and RoB-2 assessment. Random-effects meta-analyses using restricted maximum likelihood estimation were conducted. Results Ten RCTs (11 datasets; ~ 850 women) were included. Using a random-effects model with Knapp–Hartung adjustment, the pooled EBD analysis showed a mean difference of –1.08 points (95% CI –2.08 to –0.08), indicating a statistically significant improvement with EBD. The prediction interval (–3.63 to 1.48) suggests a wide range of possible effects, including no benefit. Heterogeneity was moderate (I 2 = 53%). Subgroup analysis of non-ablative Er:YAG laser showed the strongest and most homogeneous effect (MD –1.42; 95% CI –2.55 to –0.28; I 2 = 29%). CO 2 laser findings were inconsistent, and evidence for radiofrequency was insufficient. Adverse events were mild and transient. Conclusions EBDs may improve SUI symptoms compared with sham, with the most consistent benefit observed for non-ablative Er:YAG laser. However, effects are modest and short-term. High-quality RCTs with standardised protocols and long-term follow-up are needed.