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

NCT03187574 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2017-06-19

No results posted yet for this study

Summary

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.

Conditions

  • Vaginal Prolapse

Interventions

DEVICE

Elevate Ant™

Surgery with Elevate Ant™

DEVICE

Perigee™

Surgery with Perigee™

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Gery LAMBLIN · Hospices Civils de Lyon

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2015-01-31
Completion
2016-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03187574 on ClinicalTrials.gov