- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03187574
Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse (ELEPE)
June 16, 2017 updated by: Hospices Civils de Lyon
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
126
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
patients with grade ≥3 anterior prolapse
Description
Inclusion Criteria:
- symptomatic patient presenting with POP-Q grade ≥3 anterior or apical prolapse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A
group received Elevate Ant™ single-incision mesh
|
Surgery with Elevate Ant™
|
Group B
group received Perigee™ transvaginal mesh
|
Surgery with Perigee™
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits
Time Frame: 1 year post-surgery
|
1 year post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gery LAMBLIN, Hospices Civils de Lyon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2009
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
June 13, 2017
First Submitted That Met QC Criteria
June 13, 2017
First Posted (Actual)
June 15, 2017
Study Record Updates
Last Update Posted (Actual)
June 19, 2017
Last Update Submitted That Met QC Criteria
June 16, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL17_0356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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