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

Completed

• Conditions: Vaginal Prolapse
• Interventions: Device: Perigee™; Device: Elevate Ant™

• Registration Number: NCT03187574
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2015-01
• Study Completion: 2016-04
• Status Verified: 2017-05
• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-15
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

• symptomatic patient presenting with POP-Q grade ≥3 anterior or apical prolapse

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	Perigee™	group received Perigee™ transvaginal mesh
Group A	Elevate Ant™	group received Elevate Ant™ single-incision mesh

Primary Outcome Measures

Name	Time	Method
comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits	1 year post-surgery