The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
Primary Outcome Measures:
- All POPQ points (Ba, Bp or C) at Stage I (defined as descent of the leading edge to >1 cm above hymen) or less at one year. [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare patient satisfaction and Quality of Life (QOL) variables between the two arms of the trial. We will also assess complications and subjective cure rates of overall incontinence and lower urinary tract function. [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
Estimated Enrollment: |
90 |
Study Start Date: |
January 2007 |
Estimated Study Completion Date: |
January 2010 |
Estimated Primary Completion Date: |
January 2010 (Final data collection date for primary outcome measure) |
1: Active Comparator
vaginal prolapse repair with mesh
|
Device: Vaginal mesh
Vaginal prolapse repair with mesh
|
2: Active Comparator
vaginal prolapse repair without mesh
|
Device: Vaginal mesh
Vaginal prolapse repair with mesh
|
Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the technical advancements. No randomized controlled trials of different vaginal apical suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal Stage II-IV prolapse.