VAMP-A: Efficacy Study of Vaginal Mesh for Anterior Prolapse

Sponsor
Medstar Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00557882
Collaborator
(none)
65
1
2
53
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: synthetic polypropylene mesh
Phase 4

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.

Study Design

Study Type:
Interventional
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 Anterior Prolapse
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Wahington Hospital Center Washington District of Columbia United States 20010

Sponsors and Collaborators

  • Medstar Health Research Institute

Investigators

  • Principal Investigator: Andrew I Sokol, MD, Medstar Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT00557882
Other Study ID Numbers:
  • 2006-336
First Posted:
Nov 14, 2007
Last Update Posted:
Oct 30, 2020
Last Verified:
Oct 1, 2020
Keywords provided by Medstar Health Research Institute
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Mesh no Mesh
Arm/Group Description Vaginal reconstructive surgery with synthetic polypropylene mesh 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. Vaginal reconstructive surgery without mesh 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.
Period Title: Overall Study
STARTED 32 33
COMPLETED 27 33
NOT COMPLETED 5 0

Baseline Characteristics

Arm/Group Title Mesh no Mesh Total
Arm/Group Description Vaginal reconstructive surgery with synthetic polypropylene mesh 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. Vaginal reconstructive surgery without mesh 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. Total of all reporting groups
Overall Participants 32 33 65
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
32
100%
33
100%
65
100%
>=65 years
0
0%
0
0%
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
64.4
(10.8)
63.5
(8.9)
63.94
(9.89)
Sex: Female, Male (Count of Participants)
Female
32
100%
33
100%
65
100%
Male
0
0%
0
0%
0
0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
3
9.4%
3
9.1%
6
9.2%
Not Hispanic or Latino
29
90.6%
29
87.9%
58
89.2%
Unknown or Not Reported
0
0%
1
3%
1
1.5%

Outcome Measures

1. Primary Outcome
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.
Description
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
NIH optimal prolapse cure (Pelvic Organ Prolapse Quantifications System (POP-Q) stage <1)
Arm/Group Title Mesh no Mesh
Arm/Group Description Vaginal reconstructive surgery with synthetic polypropylene mesh 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. Vaginal reconstructive surgery without mesh 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.
Measure Participants 32 33
Count of Participants [Participants]
12
37.5%
10
30.3%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Mesh no Mesh
Arm/Group Description Vaginal reconstructive surgery with synthetic polypropylene mesh 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. Vaginal reconstructive surgery without mesh 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.
All Cause Mortality
Mesh no Mesh
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/32 (3.1%) 1/33 (3%)
Serious Adverse Events
Mesh no Mesh
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 5/32 (15.6%) 0/33 (0%)
Injury, poisoning and procedural complications
mesh erosion 5/32 (15.6%) 0/33 (0%)
Other (Not Including Serious) Adverse Events
Mesh no Mesh
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 4/32 (12.5%) 1/33 (3%)
General disorders
Febrile Illness 1/32 (3.1%) 1/33 (3%)
Postoperative blood transfusion 1/32 (3.1%) 0/33 (0%)
Renal and urinary disorders
cystotomy 2/32 (6.3%) 0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Andrew Sokol, MD
Organization MedStar Washington Hospital Center
Phone 2028776526
Email andrew.i.sokol@medstar.net
Responsible Party:
Medstar Health Research Institute
ClinicalTrials.gov Identifier:
NCT00557882
Other Study ID Numbers:
  • 2006-336
First Posted:
Nov 14, 2007
Last Update Posted:
Oct 30, 2020
Last Verified:
Oct 1, 2020