CompletedNot Applicable

Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence

United States50 participantsStarted 2019-01-29

Plain-language summary

This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence. Half of the participants will undergo Burch colposuspension procedure at the time of sacrocolpopexy, and half of the participants will undergo sacrocolpopexy alone.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * English or Spanish speaking and reading * Symptomatic pelvic organ prolapse with any compartment at or beyond the hymen * Stress-continent, as defined as response of "no" to question 17 of PFDI-20: "Do you usually experience urine leakage related to coughing, sneezing, or laughing?", as well as a negative empty supine stress test. * Planning laparoscopic or robotic sacrocolpopexy, with or without hysterectomy * Have completed childbearing Exclusion Criteria: * Adults unable to consent * Pregnant women or patients desiring future pregnancy * Patients undergoing uterine sparing surgery * Individuals under age 18 * Prior procedure for stress urinary incontinence * Prior retropubic surgery

What they're measuring

Number of Participants With Stress Urinary Incontinence

Timeframe: 3 months following study intervention

Trial details

NCT IDNCT03841513

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-27

Results submitted2024-12-20

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials