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Efficacy Study of Vaginal Mesh for Prolapse (VAMP)

Primary Purpose

Pelvic Organ Prolapse, Uterine Prolapse, Vaginal Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
synthetic monofilament polypropylene mesh
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring prolapse, uterus, pelvic organ, vaginal prolpase

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prolift mesh

Prolapse repair without mesh

Arm Description

vaginal prolapse repair with mesh

vaginal prolapse repair without mesh

Outcomes

Primary Outcome Measures

Number of Participants With Anatomic Cure at 3 Years
3 different measures for Anatomic cure using POPQ measurements: POP-Q at Stage I or less* (POP-Q points Ba, Bp or C -1 or less); no prolapse beyond the hymen (Ba, Bp or C 0 or less); 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

Bothersome Dyspareunia
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia

Full Information

First Posted
May 17, 2007
Last Updated
September 13, 2022
Sponsor
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00475540
Brief Title
Efficacy Study of Vaginal Mesh for Prolapse
Acronym
VAMP
Official Title
A Randomized Clinical Trial of Vaginal Mesh for Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2013 (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 pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Uterine Prolapse, Vaginal Prolapse, Cystocele, Rectocele
Keywords
prolapse, uterus, pelvic organ, vaginal prolpase

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolift mesh
Arm Type
Active Comparator
Arm Description
vaginal prolapse repair with mesh
Arm Title
Prolapse repair without mesh
Arm Type
Active Comparator
Arm Description
vaginal prolapse repair without mesh
Intervention Type
Device
Intervention Name(s)
synthetic monofilament polypropylene mesh
Other Intervention Name(s)
Prolift
Intervention Description
Vaginal prolapse repair with mesh
Primary Outcome Measure Information:
Title
Number of Participants With Anatomic Cure at 3 Years
Description
3 different measures for Anatomic cure using POPQ measurements: POP-Q at Stage I or less* (POP-Q points Ba, Bp or C -1 or less); no prolapse beyond the hymen (Ba, Bp or C 0 or less); 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
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Bothersome Dyspareunia
Description
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia
Time Frame
3 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Iglesia, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24084533
Citation
Gutman RE, Nosti PA, Sokol AI, Sokol ER, Peterson JL, Wang H, Iglesia CB. Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):770-777. doi: 10.1097/AOG.0b013e3182a49dac.
Results Reference
derived
PubMed Identifier
20664388
Citation
Iglesia CB, Sokol AI, Sokol ER, Kudish BI, Gutman RE, Peterson JL, Shott S. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2010 Aug;116(2 Pt 1):293-303. doi: 10.1097/AOG.0b013e3181e7d7f8.
Results Reference
derived

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Efficacy Study of Vaginal Mesh for Prolapse

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