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

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04829357` - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed	`NCT05493735` - Lidocaine for Pessary Check Pain Reduction	Phase 3
Completed	`NCT04512053` - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence	Phase 2
Active, not recruiting	`NCT06224335` - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting	`NCT05304312` - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women	N/A
Not yet recruiting	`NCT05527665` - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting	`NCT04558762` - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn	`NCT02524366` - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement	N/A
Completed	`NCT01924728` - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence	N/A
Completed	`NCT01676662` - Solace European Confirmatory Trial	N/A
Unknown status	`NCT01455779` - Lyrette: Renewing Continence Objective and Subjective Efficacy Study	N/A
Terminated	`NCT01029106` - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)	N/A
Withdrawn	`NCT00573703` - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence	Phase 4
Completed	`NCT01123096` - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?	N/A
Completed	`NCT01770691` - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence	N/A
Completed	`NCT00234754` - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women	N/A
Completed	`NCT00441454` - Retropubic vs. Transobturator Tension-free Vaginal Tape	N/A
Completed	`NCT03985345` - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.	N/A
Completed	`NCT04097288` - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects	Phase 1
Recruiting	`NCT05272644` - Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence	N/A