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NCT03187574 Clinical Trial

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

Vaginal Prolapse Clinical Trial

— ELEPE  

Official title:
A Prospective Comparison of Two Vaginal Mesh Kits in the Management of Anterior and Apical Vaginal Prolapse: Long Term-results for Apical Fixation and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03187574
Other study ID # 69HCL17_0356
Secondary ID
Status Completed
Phase N/A
First received June 13, 2017
Last updated June 16, 2017
Start date May 2009
Est. completion date April 2016

Study information
Verified date May 2017
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date April 2016
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Elevate Ant™
Surgery with Elevate Ant™
• Perigee™
Surgery with Perigee™

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Outcome
Type Measure Description Time frame Safety issue
Primary comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits 1 year post-surgery
See also
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Recruiting NCT05449054 - Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy N/A
Completed NCT00475540 - Efficacy Study of Vaginal Mesh for Prolapse N/A
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Completed NCT02431897 - Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen Phase 4