Efficacy Study of Vaginal Mesh for Prolapse (VAMP)

September 13, 2022 updated by: Medstar Health Research Institute

A Randomized Clinical Trial of Vaginal Mesh for Prolapse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Anatomic Cure at 3 Years
Time Frame: 3 year

3 different measures for Anatomic cure using POPQ measurements:

  1. POP-Q at Stage I or less* (POP-Q points Ba, Bp or C -1 or less);
  2. no prolapse beyond the hymen (Ba, Bp or C 0 or less);
  3. no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no.

Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bothersome Dyspareunia
Time Frame: 3 year
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 17, 2007

First Submitted That Met QC Criteria

May 17, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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