Efficacy Study of Vaginal Mesh for Anterior Prolapse (VAMP-A)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Medstar Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00557882
First received: November 13, 2007
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

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 anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.


Condition Intervention Phase
Vaginal Prolapse
Uterine Prolapse
Cystocele
Pelvic Organ Prolapse
Device: synthetic polypropylene mesh
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Vaginal Mesh for Anterior Prolapse

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • The primary outcome measure for objective treatment success is anterior prolapse, point Ba at stage 0 or 1 (defined as maximal descent of the anterior wall to greater than 1 cm above the hymen)at one year. [ Time Frame: 3 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measures for objective treatment success consist of apical and posterior prolapse, point C, Ap and Bp at stage I or less at 1 yr. Also the impact of treatment on a patient's quality of life will be assessed. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: June 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mesh
Vaginal reconstructive surgery with synthetic polypropylene mesh
Device: synthetic polypropylene mesh
Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
Active Comparator: no mesh
Vaginal reconstructive surgery without mesh
Device: synthetic polypropylene mesh
Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.

Detailed Description:

Multiple vaginal, abdominal and laparoscopic procedures have been described for surgical correction of pelvic support problems. However, conventional pelvic reconstructive surgeries have been associated with a 20-30% prolapse recurrence rate. The anterior vaginal wall is the site most often recognized as the area of vaginal prolapse recurrence. Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction in an attempt to improve surgical cure rates. Unfortunately, safety and efficacy data have lagged behind the technical advancements.

This trial will randomize women with advanced anterior wall prolapse to two treatment arms: vaginal reconstructive surgery with mesh and vaginal reconstructive surgery without mesh. The primary outcome is cure of anterior wall prolapse at one year. Secondary outcomes are cure of apical and posterior wall prolapse, quality-of-life measures and complication rates. Patients will be approached for recruitment only after they have made the decision to undergo vaginal surgery for anterior prolapse. The patient and examiner will be blinded to the surgical treatment assignment. Interim measurement of primary and secondary outcomes will be conducted three months post-operatively. Additional follow-up will be conducted at one-year intervals subsequent to the expected one-year endpoint.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. women age > 21
  2. diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery
  3. available for 12 months of follow-up
  4. able to complete study questionnaires and assessments.
  5. available for 12 months follow-up

Exclusion Criteria:

  1. Uterus in place.
  2. No anterior vaginal prolapse.
  3. 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.
  4. Current intermittent self catheterization.
  5. Pregnancy or desire for future fertility.
  6. Presence of an adnexal or ovarian mass.
  7. Shortened vagina.
  8. Other laparoscopic or abdominal/pelvic surgery in the past 3 months.*
  9. Known neurologic or medical condition affecting bladder function, e.g. multiple sclerosis, spinal cord injury.
  10. Need for surgery requiring an abdominal incision.
  11. <12 months post-partum. (Enrollment can be deferred until time requirement has been met).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557882

Locations
United States, District of Columbia
Wahington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Andrew I Sokol, MD Washington Hospital Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00557882     History of Changes
Other Study ID Numbers: 2006-336
Study First Received: November 13, 2007
Last Updated: March 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
prolapse
uterus
mesh
bladder

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Uterine Prolapse
Genital Diseases, Female
Pathological Conditions, Anatomical
Uterine Diseases

ClinicalTrials.gov processed this record on October 23, 2014