At a glance
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Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial
In Brief
A Phase 2 clinical trial evaluating TVT and Sham for Pelvic Organ Prolapse. Completed, enrolled 337 participants across 8 sites.
Detailed 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.
Study Details
Timeline
Interventions
Prophylactic TVT
Sham TVT