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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT00557882
First received: November 13, 2007
Last updated: September 21, 2015
Last verified: September 2015

November 13, 2007
September 21, 2015
June 2007
October 2009   (final data collection date for primary outcome measure)
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 ]
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. ]
Complete list of historical versions of study NCT00557882 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Efficacy Study of Vaginal Mesh for Anterior Prolapse
A Randomized Clinical Trial of Vaginal Mesh for Anterior 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 anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Vaginal Prolapse
  • Uterine Prolapse
  • Cystocele
  • Pelvic Organ Prolapse
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: mesh
    Vaginal reconstructive surgery with synthetic polypropylene mesh
    Intervention: Device: synthetic polypropylene mesh
  • Active Comparator: no mesh
    Vaginal reconstructive surgery without mesh
    Intervention: Device: synthetic polypropylene mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
November 2011
October 2009   (final data collection date for primary outcome measure)

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).
Female
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00557882
2006-336
Yes
Not Provided
Not Provided
Medstar Health Research Institute
Medstar Health Research Institute
Not Provided
Principal Investigator: Andrew I Sokol, MD Washington Hospital Center
Medstar Health Research Institute
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP