Vaginal erbium laser treatment for stress urinary incontinence: A multicenter randomized sham‐controlled clinical trial

Abstract

AbstractObjectiveTo evaluate the efficacy and safety of non‐ablative vaginal Er:YAG laser device in stress urinary incontinence (SUI) treatment.MethodsWe conducted a multicenter blinded randomized sham‐controlled trial in which women with urodynamic SUI were randomization to active arm using Er:YAG laser therapy, and sham arm using sham handpiece. Patients received two treatments 1 month apart. The primary outcomes measure was 1 h pad weight test measured at 6 months. Secondary outcomes were durability of treatment success at 12 months, and questionnaires for assessment of SUI severity (ICIQ‐UI SF), sexual function (PISQ‐12) and HRQoL (KHQ), and incidence and severity of device related adverse events and pain (VAS).ResultsA total of 110 participants with SUI were recruited; 73 in the active arm and 37 in the sham arm. Two participants were excluded; one was assigned the wrong treatment and one withdrew their consent. Treatment success was observed in 36% of the sham arm and 59% of the active arm; in the latter, odds of achieving treatment success were more than three‐fold higher (OR 3.63, 95% CI: 1.3–11.2, P = 0.02). HRQoL by KHQ showed significant improvement in the active versus the sham arm (OR 0.36, 95% CI: 0.15–0.87, P = 0.003). Similarly, subjective patient assessment of general and sexual function improvement with PISQ‐12 and PGI‐I showed superior effect over sham (OR 2.8, 95% CI: 1.2–7.0, P = 0.02 and OR 0.13, 95% CI: 0.05–0.36, P < 0.001, respectively).ConclusionNon‐ablative vaginal Er:YAG laser therapy significantly improves SUI symptoms versus sham treatment. Er:YAG laser therapy should be considered as a non‐surgical treatment option for SUI patients.