Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse
NCT01559168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121
Last updated 2025-11-19
Summary
The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.
Conditions
- Pelvic Organ Prolapse
Interventions
- DEVICE
-
UpholdTM LITE placement
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.
Sponsors & Collaborators
-
Centre Hospitalier Universitaire de Nīmes
lead OTHER
Principal Investigators
-
Renaud de Tayrac, MD PhD · Centre Hospitalier Universitaire de Nîmes
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2016-10-12
- Completion
- 2016-10-12
Countries
- France
Study Locations
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