We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study of Vaginal Mesh for Prolapse (VAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00475540
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : October 12, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : January 2007
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Prolift mesh
vaginal prolapse repair with mesh
Device: synthetic monofilament polypropylene mesh
Vaginal prolapse repair with mesh
Other Name: Prolift

Active Comparator: Prolapse repair without mesh
vaginal prolapse repair without mesh
Device: synthetic monofilament polypropylene mesh
Vaginal prolapse repair with mesh
Other Name: Prolift




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475540


Locations
Layout table for location information
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Cheryl Iglesia, MD Medstar Health Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT00475540    
Other Study ID Numbers: 2006-232
First Posted: May 21, 2007    Key Record Dates
Results First Posted: October 12, 2022
Last Update Posted: October 12, 2022
Last Verified: July 2022
Keywords provided by Medstar Health Research Institute:
prolapse
uterus
pelvic organ
vaginal prolpase
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectocele
Cystocele
Uterine Prolapse
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Uterine Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia