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Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence. — VELSUI  

Urinary Incontinence,Stress Clinical Trial

Official title:
Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.

Clinical Trial Summary

This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE). Women with symptomatic stress urinary incontinence who seek for a conservative treatment, with no history of previous incontinence-surgery will be randomised to either the laser-arm or the PFE-arm. There are 3 visits (with a maximum of 6 visits) where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators. The primary objective is to evaluate the effects of VEL treatment for the subjective cure or improvement of SUI. The secondary objectives are to measure objective outcomes, to register any adverse events, and to determine for how long the effects of laser are sustained, with a maximum of two years.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04643353
Study type Interventional
Source Universitaire Ziekenhuizen KU Leuven
Contact
Status Completed
Phase N/A
Start date November 27, 2020
Completion date December 30, 2023
View Details
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