VAMP: Efficacy Study of Vaginal Mesh for Prolapse

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00475540

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Uterine Prolapse Vaginal Prolapse Cystocele Rectocele	Device: synthetic monofilament polypropylene mesh	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Clinical Trial of Vaginal Mesh for Prolapse

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prolift mesh vaginal prolapse repair with mesh	Device: synthetic monofilament polypropylene mesh Vaginal prolapse repair with mesh Other Names: Prolift
Active Comparator: Prolapse repair without mesh vaginal prolapse repair without mesh	Device: synthetic monofilament polypropylene mesh Vaginal prolapse repair with mesh Other Names: Prolift

Arm

Intervention/Treatment

Active Comparator: Prolift mesh

vaginal prolapse repair with mesh

Device: synthetic monofilament polypropylene mesh

Vaginal prolapse repair with mesh

Other Names:

Prolift

Active Comparator: Prolapse repair without mesh

vaginal prolapse repair without mesh

Device: synthetic monofilament polypropylene mesh

Vaginal prolapse repair with mesh

Other Names:

Prolift

Outcome Measures

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. [3 year]

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. [3 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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