Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-04-30

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.

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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.

Conditions

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Cystocele Uterine Prolapse Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Anterior Colporrhaphy (sutured repair)

Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures.

Group Type PLACEBO_COMPARATOR

sutured anterior vaginal prolapse repair

Intervention Type PROCEDURE

anterior vaginal prolapse repair with suture

Perigee (grafted repair)

Anterior vaginal prolapse repair with graft

Group Type ACTIVE_COMPARATOR

grafted anterior prolapse repair

Intervention Type DEVICE

anterior vaginal prolapse repair with graft

Interventions

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grafted anterior prolapse repair

anterior vaginal prolapse repair with graft

Intervention Type DEVICE

sutured anterior vaginal prolapse repair

anterior vaginal prolapse repair with suture

Intervention Type PROCEDURE

Other Intervention Names

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Perigee Transobturator Prolapse Repair System cystocele repair

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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes