Safety and efficacy of vaginal laser therapy for stress urinary incontinence: a meta-analysis.

Background: Laser therapy has recently been proposed as a novel treatment for stress urinary incontinence (SUI) due to offering several advantages. This study aimed to evaluate the safety and efficacy of laser treatment of SUI by a meta-analysis.

Methods: The systematic review registration number is INPLASY202080001. A comprehensive search to identify relevant studies was conducted using the PubMed, Embase, Cochrane Library, CNKI, VIP and Wanfang databases with a cutoff date of 1 November, 2020. Outcome measures were extracted based on subjective and objective indexes, including International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and objective measurements "1-hour pad test" (1-hour test under standardized conditions). Score changes before and after treatment were evaluated through meta-analysis. Subgroup analysis was performed according to geographic region, type of urinary incontinence (UI), severity of UI, age, and body mass index (BMI).

Results: Sixteen published clinical research studies, involving 899 patients with SUI, were included in this study. After laser treatment, the change in the ICIQ-SF score at 1, 2, and 6 months was -5.49 (95% CI: -6.74--4.24; I2=91%, P<0.01), -4.97 (95% CI: -6.24--3.71), and -5.48 (95% CI: -6.15--4.81), respectively. The improvement in 1-hour pad weight test results at 1, 3, and 12 months post treatment was -5.59 (95% CI: -6.93--4.25), -4.96 (95% CI: -6.73--3.20), and -5.82 (95% CI: -6.77--4.87), respectively. The PISQ-12 score increased by 5.39 (95% CI: 1.20-9.58) following treatment. Subgroup analysis identified the type and severity of UI as the potential source of heterogeneity. Adverse effects were reported in 6 of the 16 trials and affected only a small number of patients. Most adverse events were mild or moderate and required no medical intervention or resolved in a few days.

Conclusions: Vaginal laser therapy appears to be a safe, effective, and minimally invasive treatment option for SUI that can be well tolerated by patients.