Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial
Condition: Pelvic Organ Prolapse
MeSH terms: Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Intervention: TVT; Sham
Intervention description: Prophylactic TVT; Sham TVT
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 337.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prolapse; Urinary incontinence; TVT

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 criteria:

        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).