Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-05 @ 11:29 PM
Study NCT ID:
NCT01559168
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2012-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Secondary objectives include the evaluation of the following:
* Change from baseline of POP-Q scoring at 6 weeks, 6 months and 12 months post procedure, including evolution of treated or non-treated posterior compartments.
* The proportion of patients with anatomical prolapse (C/D), but who are asymptomatic.
* Change from baseline of mean quality-of-life scores.
* Evaluation of mesh properties from procedure date through study period.
* Peri-operative and post-treatment pain score assessment comparing the various anesthesia regimes used (Visual Analog Scale).
* Assessment of patient subjective outcomes for overall treatment effects and satisfaction.
* Objective evaluation of mesh shrinkage by standardized ultrasound measurements.
* Change from baseline of POP-Q scoring at 6 weeks, 6 months and 12 months post procedure, including evolution of treated or non-treated posterior compartments.
* The proportion of patients with anatomical prolapse (C/D), but who are asymptomatic.
* Change from baseline of mean quality-of-life scores.
* Evaluation of mesh properties from procedure date through study period.
* Peri-operative and post-treatment pain score assessment comparing the various anesthesia regimes used (Visual Analog Scale).
* Assessment of patient subjective outcomes for overall treatment effects and satisfaction.
* Objective evaluation of mesh shrinkage by standardized ultrasound measurements.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-A01705-36 | OTHER | ANSM | View |