Vaginal Laser Treatment on Stress Urinary Incontinence: A Randomized Controlled Trial.

Abstract

Introduction and hypothesis: This study evaluates the efficacy of vaginal Erbium:YAG laser treatment for stress urinary incontinence (SUI) compared with sham treatment over 12 months.

Methods: This single-blinded, multicenter randomized controlled trial involved women diagnosed with urodynamic SUI at three urogynecology centers in Hong Kong. Participants were randomly assigned to receive either vaginal laser therapy (two sessions, 4 weeks apart) or sham treatment. The primary outcome was the reduction in Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) Stress subscale scores at 6 and 12 months. Secondary outcomes included urinary incontinence episodes, severity from bladder diaries, visual analog scale (VAS) scores, and scores from the Pelvic Floor Impact Questionnaire Urinary Impact Questionnaire and the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form.

Results: Out of 114 screened women, 75 were randomized. Significant reductions in PFDI UDI stress subscale scores were shown in the treatment group at the 6-month and 12-month follow-up (p < 0.001 at 6 months; p < 0.001 at 12 months) but was not significant in the control group. Significant reductions were observed in the treatment group at the 6-month and 12-month follow-up in all secondary outcome parameters whereas the Pelvic Floor Impact Questionnaire UDI score and the VAS score of SUI severity at both 6 months and 12 months were not significantly reduced in the control group. There was no significant difference in both primary or secondary outcomes between groups.

Conclusions: Vaginal Erbium: YAG laser improved SUI symptoms and shows potential as a minimally invasive option, but lacks significant differences from sham treatment, necessitating further research.