Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Study Overview
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Brief Summary
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The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.

Detailed Description
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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.

Official Title
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Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial

Conditions
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Cystocele, Uterine Prolapse, Urinary Incontinence

Intervention / Treatment
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* Device: grafted anterior prolapse repair
* Procedure: sutured anterior vaginal prolapse repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stage II or greater anterior vaginal prolapse requiring surgical correction age 21 years and older Exclusion Criteria: less than Stage II anterior vaginal prolapse decline participation pregnant or contemplating future pregnancy prior anterior vaginal prolapse repair with biologic or synthetic graft active or latent systemic infection compromised immune system previous pelvic irradiation or cancer known hypersensitivity to polypropylene uncontrolled diabetes mellitus unable or unwilling to give valid informed consent unable or unwilling to comply with the protocol scheduled to undergo concomitant Burch colposuspension or pubovaginal sling

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Anterior Colporrhaphy (sutured repair)<br>Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures. | Procedure: sutured anterior vaginal prolapse repair<br>* anterior vaginal prolapse repair with suture<br>* Other names: cystocele repair;|
| Active Comparator: Perigee (grafted repair)<br>Anterior vaginal prolapse repair with graft | Device: grafted anterior prolapse repair<br>* anterior vaginal prolapse repair with graft<br>* Other names: Perigee Transobturator Prolapse Repair System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Stage II or Greater Anterior Vaginal Prolapse | 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. | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Calculated as time from first incision to time of closure of last incision. | perioperative | 
| Vaginal Mesh Exposure | 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. | perioperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystocele, uterine prolapse, urinary incontinence