Efficacy Study of Vaginal Mesh for Prolapse

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse Uterine Prolapse Vaginal Prolapse Cystocele Rectocele

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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Prolift mesh

vaginal prolapse repair with mesh

Group Type ACTIVE_COMPARATOR

synthetic monofilament polypropylene mesh

Intervention Type DEVICE

Vaginal prolapse repair with mesh

Prolapse repair without mesh

vaginal prolapse repair without mesh

Group Type ACTIVE_COMPARATOR

synthetic monofilament polypropylene mesh

Intervention Type DEVICE

Vaginal prolapse repair with mesh

Interventions

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synthetic monofilament polypropylene mesh

Vaginal prolapse repair with mesh

Intervention Type DEVICE

Other Intervention Names

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Prolift

Eligibility Criteria

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Inclusion Criteria

* Woman \> 21 yrs
* Stage II-IV vaginal prolapse
* Desires vaginal reconstructive surgery
* Able to complete study questionnaires and assessments
* Uterus \< 12 weeks size
* Available for 12 months follow-up

Exclusion Criteria

* Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system.
* Current intermittent catheterization.
* Pregnancy or desire for future fertility.
* Presence of an adnexal mass.
* Shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys).
* Other laparoscopic or abdominal/pelvic surgery in the past 3 months.
* Known neurologic or medical condition affecting bladder function, e.g. Multiple Sclerosis, spinal cord injury.
* Need for concomitant surgery requiring an abdominal incision.
* \< 12 months post-partum.
* Non-english speaking

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No