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Efficacy Study of Vaginal Mesh for Anterior Prolapse

NCT ID: NCT00557882

Last Updated: 2020-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Vaginal Prolapse Uterine Prolapse Cystocele Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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mesh

Vaginal reconstructive surgery with synthetic polypropylene mesh

Group Type ACTIVE_COMPARATOR

synthetic polypropylene mesh

Intervention Type DEVICE

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.

no mesh

Vaginal reconstructive surgery without mesh

Group Type ACTIVE_COMPARATOR

synthetic polypropylene mesh

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew I Sokol, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

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Wahington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Related Links

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http://medstarresearch.org/

Click clinical trials for more information about this study " A Randomized Clinical trial of Vaginal Mesh for Prolapse"

Other Identifiers

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2006-336

Identifier Type: -

Identifier Source: org_study_id