Efficacy Study of Vaginal Mesh for Anterior Prolapse (VAMP-A)
Primary Purpose
Vaginal Prolapse, Uterine Prolapse, Cystocele
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
synthetic polypropylene mesh
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Prolapse focused on measuring prolapse, uterus, mesh, bladder
Eligibility Criteria
Inclusion Criteria:
- women age > 21
- diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery
- available for 12 months of follow-up
- able to complete study questionnaires and assessments.
- available for 12 months follow-up
Exclusion Criteria:
- Uterus in place.
- No anterior vaginal prolapse.
- 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 self catheterization.
- Pregnancy or desire for future fertility.
- Presence of an adnexal or ovarian mass.
- Shortened vagina.
- 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 surgery requiring an abdominal incision.
- <12 months post-partum. (Enrollment can be deferred until time requirement has been met).
Sites / Locations
- Wahington Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
mesh
no mesh
Arm Description
Vaginal reconstructive surgery with synthetic polypropylene mesh
Vaginal reconstructive surgery without mesh
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00557882
First Posted
November 13, 2007
Last Updated
October 8, 2020
Sponsor
Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00557882
Brief Title
Efficacy Study of Vaginal Mesh for Anterior Prolapse
Acronym
VAMP-A
Official Title
A Randomized Clinical Trial of Vaginal Mesh for Anterior Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. 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 anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Prolapse, Uterine Prolapse, Cystocele, Pelvic Organ Prolapse
Keywords
prolapse, uterus, mesh, bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mesh
Arm Type
Active Comparator
Arm Description
Vaginal reconstructive surgery with synthetic polypropylene mesh
Arm Title
no mesh
Arm Type
Active Comparator
Arm Description
Vaginal reconstructive surgery without mesh
Intervention Type
Device
Intervention Name(s)
synthetic polypropylene mesh
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women age > 21
diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery
available for 12 months of follow-up
able to complete study questionnaires and assessments.
available for 12 months follow-up
Exclusion Criteria:
Uterus in place.
No anterior vaginal prolapse.
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 self catheterization.
Pregnancy or desire for future fertility.
Presence of an adnexal or ovarian mass.
Shortened vagina.
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 surgery requiring an abdominal incision.
<12 months post-partum. (Enrollment can be deferred until time requirement has been met).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew I Sokol, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wahington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Links:
URL
http://medstarresearch.org/
Description
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Efficacy Study of Vaginal Mesh for Anterior Prolapse
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