VELSUI 39 ABSTRACT Introduction and Hypothesis: Current studies on vaginal laser therapy for the management of stress urinary incontinence (SUI) are inconclusive, and many lack comparison to another conservative treatment. Therefore, we compared the efficacy of Er:YAG laser for SUI to that of pelvic floor muscle training (PFMT). Methods: Single centre, randomised controlled trial comparing laser treatment (3-6 applications) to PFMT (9-18 sessions) in women with mild to moderate SUI. Main outcome measures included subjective change in urinary incontinence symptoms by change from baseline to four months after randomisation by Urogenital Distress Inventory-6 (UDI-6) (primary), adverse events, other subjective and objective outcomes up to 24 months. A priori sample size calculation for a non-inferiority study resulted in 28 patients per arm. Because of a higher than expected dropout early in the study, we increased our sample size from 56 to 60, without unblinding of the data. Results: Sixty women were enrolled. Two participants discontinued their allocated treatment (one in each group). At four months, mean difference in change of UDI-6 scores was -6.99(95% CI=- 22.34;8.37) demonstrating non-inferiority of laser to PFMT (p=0.023). Within groups, most patients improved, yet subjective cure was reached in only a minority (laser:11%(3/28); PFMT:8%(2/26)). The mean number of treatment visits was 4.25 (SD 1.17) in the laser group and 10.04 (SD 6.36) in the PFMT group. There were no subjective or objective inter-group differences. At 24 months, the majority of patients requested additional, yet alternative treatment. There were no serious adverse events at any time-point. Conclusions: Treatment effect of vaginal laser and PFMT in patients with mild and moderate SUI were comparable, limited and short lasting. No adverse events were reported.
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