NCT00460434

Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: NICHD Pelvic Floor Disorders Network · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 adding TVT® at the time of the prolapse surgery among women with anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence. The primary aims are: In stress continent women planning vaginal surgery for pelvic organ prolapse: 1. To determine if the failure rate defined by subsequent treatment for urinary incontinence, signs or symptoms of bothersome urinary incontinence \[defined as having at least moderate bother for any of 4 Pelvic Floor Distress Inventory (PFDI) incontinence items\] differs between vaginal prolapse repair and vaginal prolapse repair plus TVT® during the first 3 months after the index surgery. 2. To determine if the prevalence of bothersome urinary incontinence at 12 months after the index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus TVT®, whether or not there was subsequent treatment for symptoms of urinary incontinence; i.e., to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding a TVT® at the time of the prolapse surgery. 3. To measure the total cost of care and relate the difference in cost of care between the two groups to differences in health utilities and health-related quality of life, which will allow us to examine the cost-effectiveness of prophylactic use of a TVT® at the time of prolapse surgery versus symptom-specific treatment of stress incontinence after prolapse surgery.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	TVT	Prophylactic TVT
OTHER	Sham	Sham TVT

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2007-04-16
• Last updated: 2018-05-30
• Results posted: 2017-09-11

Locations

8 sites across 1 country: United States