Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
|Cystocele Uterine Prolapse Urinary Incontinence||Device: grafted anterior prolapse repair Procedure: sutured anterior vaginal prolapse repair||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial|
- Recurrent Stage II or Greater Anterior Vaginal Prolapse [ Time Frame: three years ]Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal prolapse is defined as POPQ Point Ba measurement equal to or greater (more positive) than -1.
- Operative Time [ Time Frame: perioperative ]Calculated as time from first incision to time of closure of last incision.
- Vaginal Mesh Exposure [ Time Frame: perioperative ]Vaginal mesh exposure defined as appearance of mesh, placed during the index surgery, not covered by overlying vaginal epithelium on postoperative pelvic exams subsequent to the first postoperative exam. May be either symptomatic or asymptomatic. This was not differentiated in the statistical analysis.
|Study Start Date:||January 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Anterior Colporrhaphy (sutured repair)
Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures.
Procedure: sutured anterior vaginal prolapse repair
anterior vaginal prolapse repair with suture
Other Name: cystocele repair
Active Comparator: Perigee (grafted repair)
Anterior vaginal prolapse repair with graft
Device: grafted anterior prolapse repair
anterior vaginal prolapse repair with graft
Other Name: Perigee Transobturator Prolapse Repair System
Successful correction of anterior vaginal prolapse remains one of the most challenging aspects of pelvic reconstructive surgery. Up to 70% have recurrent prolapse following anterior colporrhaphy. The low success rate has consequently led to widespread use of grafts in anterior vaginal prolapse repair. While both biologic grafts and polyglactin 910 mesh have yielded disappointing results, uncontrolled studies have demonstrated low recurrence rates with polypropylene mesh reinforcement.
The Perigee Transobturator Prolapse Repair System (Perigee TPRS) (American Medical Systems, Minnetonka, Minnesota) is used to repair anterior vaginal prolapse via a transobturator approach. Specially-designed helical needles are utilized to attach either a porcine dermal (InteXenTM) or soft polypropylene (InteProTM) graft to the pelvic sidewall at four points. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the Perigee TPRS with polypropylene mesh to that of anterior colporrhaphy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535301
|United States, California|
|Downey, California, United States, 90242|
|Principal Investigator:||John N Nguyen, MD||Southern California Permanente Medical Group|