Status:
COMPLETED
Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Friends of Prentice
Conditions:
Pelvic Organ Prolapse
Urinary Incontinence,Stress
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 und...
Detailed Description
In the United States it is estimated that 13% of women will undergo surgery for POP by age 80. In patients without symptoms of stress urinary incontinence (SUI), surgical correction of pelvic organ pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03841513
Start Date
January 29 2019
End Date
September 27 2022
Last Update
August 26 2025
Active Locations (2)
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1
Northwestern University Prentice Women's Hospital
Chicago, Illinois, United States, 60611
2
Loyola University Hospital
Maywood, Illinois, United States, 60153