Vaginal Erbium Laser for the Treatment of Mild‐to‐Moderate Stress Urinary Incontinence: A Multicentre Randomised Sham–Controlled Trial

Objective To assess whether Er:YAG laser is superior to sham in treating women with mild/moderate stress urinary incontinence (SUI). Design A single blinded, multi‐centre RCT comparing Er:YAG laser to sham in women with mild/moderate SUI with patients blinded to allocated treatment. Setting Three urogynaecology departments in United Kingdom, Switzerland and Germany. Population or Sample 79 participants were recruited with mild/moderate SUI. Methods Participants were randomised (2 active: 1 sham) receiving 3 treatment sessions. Participants were assessed at baseline and 6 months post final treatment. Main Outcome Measures Primary outcome measure: cure defined as at least 50% reduction in 1 h pad weigh test (PWT) at 6 months compared to baseline (as per FDA guidelines). Secondary Outcomes: Change in PWT, (ICIQ‐UI SF), (PISQ‐12), cough test standing and supine and visual analogue score for pain. Results 32/51 patients (62.7%) of patients were defined as cured (per FDA guidelines) in the laser group compared with 4/23 (18.2%) cure in the sham group, p < 0.001, (OR 7.6, 2.2–25.8 95% CI). There was a statistically and clinically significant improvement in patients treated with laser in PWT, ICIQ‐UI SF and PISQ‐12 at 6 months (3 g, p = 0.002, 5 points, p < 0.001 and 6 points, p < 0.001, respectively). There was no evidence of statistically significant differences in the sham group. Conclusions This RCT demonstrates a beneficial effect of Er:YAG laser in women with mild/moderate SUI compared with sham. Trial Registration www.clinicaltrials.gov (NCT03996070)