NCT00460434

Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00460434

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial

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 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.

Eligibility

Inclusion Criteria:

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 Criteria:

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).

Disease(s) and\or Condition(s)

Pelvic Organ Prolapse

Primary Purpose

PREVENTION

Intervention/Treatment

- Type: DEVICE
- Name: TVT
- Description: Prophylactic TVT
- Arm Group Labels: 1
- Type: OTHER
- Name: Sham
- Description: Sham TVT
- Arm Group Labels: 2

Sponsor

NICHD Pelvic Floor Disorders Network