Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01559168
Study type	Interventional
Source	Centre Hospitalier Universitaire de Nimes
Contact
Status	Completed
Phase	N/A
Start date	October 2012
Completion date	July 15, 2016

View Details

See also
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