Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

Completed · Phase 2 · Has a placebo group

Conditions studied: Pelvic Organ Prolapse

In brief

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 women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.

Key facts

Study ID

NCT00460434

Run by

NICHD Pelvic Floor Disorders Network

People needed

337

Starts

2007-05-01

Expected to finish

2011-03-01

Last updated by the study team

2018-05-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• USCD Medical Center — La Jolla, California, United States
• Kaiser Permanente — San Diego, California, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UT Southwestern — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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