Double-blind randomized controlled trial of Er: YAG vaginal laser to treat female stress urinary incontinence

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

Objective: This study aimed to determine the efficacy of erbium-doped yttrium aluminum garnet laser as a therapy for stress urinary incontinence.

Study design: This was a double-blind randomized sham-controlled trial with 6-week and 6-month follow-ups at a single tertiary hospital setting with 144 adult female patients with symptomatic stress urinary incontinence. Each participant received 2 vaginal laser therapies 6 weeks apart, with patients randomized to either laser or sham. The primary outcome was patients' subjective reporting of no urinary incontinence at 6 months after treatment on question 3 of the International Consultation on Incontinence Questionnaire-Short Form. The secondary outcomes included objective measures of urine loss with 24-hour pad tests, 3 incontinence symptom questionnaires (Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, and International Consultation on Incontinence Questionnaire-Short Form), 1 quality-of-life questionnaire (King's Health Questionnaire), and 1 sexual function questionnaire (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire).

Results: Of 263 individuals approached, 76 of 144 individuals were randomized to the laser treatment group, and 68 of 144 individuals were randomized to the sham treatment group. There was no difference in the reported cure rate and the primary outcome at 6 months after treatment between the groups (laser treatment group: 0.0136; 95% confidence interval, 0.0006-0.0811; sham treatment group: 0.0000; 95% confidence interval, 0.0000-0.0666). Apart from a statistically significant difference noted at 6 weeks after treatment 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 2 groups at 6 weeks and 6 months after treatment.

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