NCT03187574

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
Last Updated

June 19, 2017

Status Verified

May 1, 2017

Enrollment Period

5.7 years

First QC Date

June 13, 2017

Last Update Submit

June 16, 2017

Conditions

Vaginal Prolapse

Keywords

vaginal prolapse, mesh kit, anatomic assessment, quality of life

Outcome Measures

Primary Outcomes (1)

  • comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits

    1 year post-surgery

Study Arms (2)

Group A

group received Elevate Ant™ single-incision mesh

Device: Elevate Ant™

Group B

group received Perigee™ transvaginal mesh

Device: Perigee™

Interventions

Elevate Ant™DEVICE

Surgery with Elevate Ant™

Group A
Perigee™DEVICE

Surgery with Perigee™

Group B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with grade ≥3 anterior prolapse

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Gery LAMBLIN

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

May 1, 2009

Primary Completion

January 1, 2015

Study Completion

April 1, 2016

Last Updated

June 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share