VAMP: Efficacy Study of Vaginal Mesh for Prolapse

Medstar Health Research Institute (Other)
Overall Status
Completed ID

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
  • 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:
Actual Enrollment :
65 participants
Intervention Model:
Parallel Assignment
Double (Participant, Outcomes Assessor)
Primary Purpose:
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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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


    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 Washington Hospital Center Washington District of Columbia United States 20010

    Sponsors and Collaborators

    • Medstar Health Research Institute


    • Principal Investigator: Cheryl Iglesia, MD, Medstar Health Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Medstar Health Research Institute Identifier:
    Other Study ID Numbers:
    • 2006-232
    First Posted:
    May 21, 2007
    Last Update Posted:
    Sep 23, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Medstar Health Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 23, 2015