NCT03671694

Laser Vaginal Treatment for SUI

Laser Vaginal Treatment for Stress Urinary Incontinence

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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?

Detailed 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).

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Erbium-YAG laser vaginal treatment	Erbium-YAG laser vaginal treatment

Timeline

• Start date: 2018-09-19
• Primary completion: 2023-11-24
• Completion: 2025-11-30
• First posted: 2018-09-14
• Last updated: 2024-02-15

Locations

1 site across 1 country: Canada