Vaginal laser trials for genitourinary syndrome of menopause and stress urinary incontinence: a critical methodological review of dosimetry, sham design, clinical meaningfulness, and harm

Vaginal laser therapy has been studied for genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI).However, sham-controlled trials remain difficult to interpret because carbon dioxide (CO 2 ) and erbium:yttrium-aluminum-garnet procedures are physically distinct and incompletely reported.This structured critical narrative review used a targeted search of PubMed/MEDLINE and ClinicalTrials.gov,supplemented by citation searching through August 26, 2026.Within the targeted source set, 10 GSM trials reported 524 randomized participants, and 10 SUI trials reported 941 women randomized to eligible laser or sham arms.Six of the eight CO 2 trials for GSM did not show a statistically significant advantage of laser over sham for their principal patient-reported outcomes.SUI trial results were inconsistent, with objective or composite pad-test endpoints more often favoring laser than patient-reported outcomes.Among the available reports for these 20 trials, none provided all the laser settings and delivery details needed to estimate exposure at vaginal tissue, and none reported independent measurement of actual laser output.Zero-energy shams may have remained perceptibly different because active treatment caused pain, heat, discharge, or spotting.Adverse events were usually transient, but sample sizes and follow-up were inadequate to characterize uncommon or delayed complications.Current evidence does not establish a reproducible, clinically meaningful average benefit with adequately characterized long-term safety.Future trials should report delivered exposure, validate sham credibility, prespecify patient-centered thresholds, and conduct longterm surveillance of adverse events.