Laser Vaginal Treatment for SUI

Status Active, not recruiting

Clinical Trial Summary

RCT designed to answer the question: Does the application of Erbium: YAG laser treatment to the vagina improve urine control for women with SUI?

Clinical Trial Description

This is a double blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm followed by an open label trial at 6 months for any sham treatment arm participants who do not meet treatment success. The primary goal is to compare the subjective success rates for the resolution of UI for the vaginal laser treatment at 6 months. Secondary aims include an assessment of complications, resolution of SUI symptoms (objective and subjective measures), patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 182 patients. At the 6-month post treatment evaluation, the treatment allocation will be unmasked. The trial will be of approximately 3 years in duration (1 year to recruit and 2 years for follow up). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03671694
Study type	Interventional
Source	Sunnybrook Health Sciences Centre
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 19, 2018
Completion date	November 30, 2025

View Details

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