Status:
COMPLETED
Comparison of Burch Urethropexy and Mid-urethral Sling Performed Concomitantly With a Sacral Colpopexy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Corewell Health West
Saint Luke's Health System
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
21+ years
Phase:
PHASE4
Brief Summary
I. Specific Aims Pelvic organ prolapse is a common and distressing condition that is frequently associated with stress urinary incontinence (SUI) and often requires surgical repair. Abdominal sacral ...
Eligibility Criteria
Inclusion
- older than 21 years of age;
- with symptomatic pelvic organ prolapse (POP-Q point Aa or C at ≥ -1 cm;
- who have opted for sacral colpopexy repair of prolapse;
- who have symptomatic SUI desiring surgical correction or who have occult SUI;
- who have urethral hypermobility;
- with a maximal cystometric capacity ≥ 200 cc;
- who are willing to return for follow-up visit; or
- who understand and have signed written informed consent to undergo randomization and who has given investigators permission to collect data pertaining to surgical care and follow-up.
Exclusion
- with known or suspected disease that affect bladder function (i.e., multiple sclerosis, Parkinson's Disease, spinal cord injury, etc.);
- who are pregnant by self report or by positive pregnancy test;
- who desire to maintain fertility;
- with history of urethral diverticulum;
- with a history of radical pelvic surgery or pelvic radiation therapy;
- who are deemed medically poor candidates for abdominal surgery;
- Non-ambulatory (including those who ambulate with assistance; or
- who are actively undergoing chemotherapy or radiation treatment for malignancy.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00934999
Start Date
June 1 2009
End Date
October 1 2015
Last Update
August 14 2023
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905