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

Objective: To evaluate the efficacy and safety of non-ablative vaginal Er:YAG laser device in stress urinary incontinence (SUI) treatment. Methods: We 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). Results: A 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). Conclusion: Non-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.