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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03187574

Acronym

ELEPE

Enrollment

126

Registered

2017-06-15

Start date

2009-05-31

Completion date

2016-04-30

Last updated

2017-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Prolapse

Keywords

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

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.

Interventions

DEVICEElevate Ant™

Surgery with Elevate Ant™

DEVICEPerigee™

Surgery with Perigee™

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026