Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse (ELEPE)

Civil Hospices of Lyon

Status: Completed

Conditions: Vaginal Prolapse

Treatments: Device: Perigee™; Device: Elevate Ant™

Study type: Observational

Funder types: Other

Identifiers

NCT03187574

69HCL17_0356

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

126 participants in 2 patient groups

Group A

Description:

group received Elevate Ant™ single-incision mesh

Treatment:

Device: Elevate Ant™

Group B

Description:

group received Perigee™ transvaginal mesh

Treatment:

Device: Perigee™