Trials / Completed
CompletedNCT03187574
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 126 (actual)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Elevate Ant™ | Surgery with Elevate Ant™ |
| DEVICE | Perigee™ | Surgery with Perigee™ |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2015-01-01
- Completion
- 2016-04-01
- First posted
- 2017-06-15
- Last updated
- 2017-06-19
Source: ClinicalTrials.gov record NCT03187574. Inclusion in this directory is not an endorsement.