Status:
COMPLETED
Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Collaborating Sponsors:
Office of Research on Women's Health (ORWH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some wome...
Detailed Description
The overall objective of this randomized clinical trial is to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by addi...
Eligibility Criteria
Inclusion
- Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:
- Do you usually have a sensation of bulging or protrusion from the vaginal area?
- Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Anterior vaginal prolapse defined by pelvic organ prolapse quantification (POP-Q) Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm).
- Surgical plan that includes a vaginal approach for apical or anterior prolapse repair.
- Able and willing to complete data collection per protocol, including written informed consent.
Exclusion
- Pregnancy or planning pregnancy in the first postoperative year. Any prior mid urethral sling. Currently participating in another interventional study for urinary incontinence.
- Untreated urinary tract infection (may be included after resolution).
- Overt symptoms of stress urinary incontinence as defined by a positive response to any of the following 3 PFDI items:
- Do you usually experience urine leakage related to coughing, sneezing, or laughing?
- Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?
- Do you usually experience urine leakage related to lifting or bending over? Currently being treated for stress urinary incontinence with pessary/incontinence ring, pelvic floor muscle exercise or medication (duloxetine and imipramine, and alpha agonists).
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT00460434
Start Date
May 1 2007
End Date
March 1 2011
Last Update
May 30 2018
Active Locations (8)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233-7333
2
USCD Medical Center
La Jolla, California, United States, 92037
3
Kaiser Permanente
San Diego, California, United States, 92120
4
Loyola University Medical Center
Maywood, Illinois, United States, 60153