Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse

NCT ID: NCT03187574

Last Updated: 2017-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2016-04-30

Brief Summary

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Our study is a non-randomized prospective study compared two groups matched for anterior/apical POP-Q grade: 84 received Elevate Ant™ single-incision mesh (group A) and 42 Perigee™ transvaginal mesh (group B). The study hypothesis was that the Elevate Ant™ mesh would provide better apical correction than the Perigee™ mesh. One- and 2-year follow-up comprised anatomic assessment (POP-Q) and QoL (PFDI-20, PFIQ-7, PISQ-12). Success was defined as 2-year POP-Q ≤1. Secondary endpoints were function and complications.

Detailed Description

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Conditions

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Vaginal Prolapse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

group received Elevate Ant™ single-incision mesh

Elevate Ant™

Intervention Type DEVICE

Surgery with Elevate Ant™

Group B

group received Perigee™ transvaginal mesh

Perigee™

Intervention Type DEVICE

Surgery with Perigee™

Interventions

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Elevate Ant™

Surgery with Elevate Ant™

Intervention Type DEVICE

Perigee™

Surgery with Perigee™

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* symptomatic patient presenting with POP-Q grade ≥3 anterior or apical prolapse
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gery LAMBLIN

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Other Identifiers

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69HCL17_0356

Identifier Type: -

Identifier Source: org_study_id

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