Double-blinded randomized controlled trial of Erbium-YAG Laser to treat Female Stress Urinary Incontinence

Patricia Lee; Darian Perruzza; Humara Edell; Stephanie Jarvi; Katherine Kim; Razia Sultana; Nasrin Alavi; Alex Kiss; Xingshan Cao; Louise-Helene Gagnon; Janet Bodley; Lesley Carr; Sender Herschorn; Rose Kung

doi:10.1016/j.ajog.2024.11.021

Double-blinded randomized controlled trial of Erbium-YAG Laser to treat Female Stress Urinary Incontinence

Am J Obstet Gynecol. 2024 Nov 25:S0002-9378(24)01160-8. doi: 10.1016/j.ajog.2024.11.021. Online ahead of print.

Authors

Affiliations

¹ Division of Urogynecology, Dept of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. Electronic address: pel.lee@utoronto.ca.
² Sunnybrook Research Institute, Toronto, Ontario, Canada.
³ Division of Urogynecology, Dept of Obstetrics and Gynecology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
⁴ Sunnybrook Research Institute, Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences, University of Toronto.
⁵ Division of Urology, Dept of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.

PMID: 39603442
DOI: 10.1016/j.ajog.2024.11.021

Abstract

Background: Stress urinary incontinence affects approximately 40% of adult females and is often treated surgically. Minimally invasive laser vaginal therapy to treat stress urinary incontinence has become widely available, but the efficacy of this novel therapy is unclear.

Objective: To determine the efficacy of Erbium-Yttrium Aluminum Garnet (Er-YAG) laser therapy as a treatment for stress urinary incontinence.

Study design: Randomized sham-controlled, double-blinded trial with 6-week and 6-month follow-up at a single tertiary hospital setting with 144 adult female patients with symptomatic stress urinary incontinence. Each participant received two vaginal laser treatments 6-weeks apart, with patients randomized to either laser or sham. The primary outcome was patients' subjective reporting of no urinary incontinence 6-months post-treatment on question 3 of the International Consultation on Incontinence Questionnaire-Short Form. Secondary outcomes included objective measures of urine loss with 24-hour pad tests, three incontinence symptom questionnaires (using Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, and International Consultation on Incontinence Questionnaire-Short Form questionnaires), one quality of life questionnaire (King's Health Questionnaire) and one sexual function questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire).

Results: Of 263 approached, 76/144 and 68/144 were randomized to the laser and sham treatment group respectively. There was no difference between the groups in the reported cure rate, the primary outcome, at 6-months: Laser group, 0.013 (1/76) with 95% confidence interval (0.0006-0.0811) and sham group, 0/68 with 95% confidence interval (0-0.0666). Apart from a statistically significant difference noted at 6-weeks in 1 of 3 incontinence questionnaires and 3 of 9 domains of the quality-of-life questionnaire, there were no other significant differences in our subjective or objective measures between the two groups at 6-weeks and at 6-months post treatment.

Conclusion: Er-YAG laser vaginal treatment was no more effective than sham for curing or improving female stress urinary incontinence at 6-months.

Keywords: Erbium-YAG laser; Stress urinary incontinence; female; randomized controlled trial; vaginal laser treatment.