ELEPE: Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse
Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03187574
Collaborator
(none)
126
83
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
126 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Actual Study Start Date
:
May 1, 2009
Actual Primary Completion Date
:
Jan 1, 2015
Actual Study Completion Date
:
Apr 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group A group received Elevate Ant™ single-incision mesh |
Device: Elevate Ant™
Surgery with Elevate Ant™
|
| Group B group received Perigee™ transvaginal mesh |
Device: Perigee™
Surgery with Perigee™
|
Outcome Measures
Primary Outcome Measures
- comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits [1 year post-surgery]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- symptomatic patient presenting with POP-Q grade ≥3 anterior or apical prolapse
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Gery LAMBLIN, Hospices Civils de Lyon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03187574
Other Study ID Numbers:
- 69HCL17_0356
First Posted:
Jun 15, 2017
Last Update Posted:
Jun 19, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms: