Clinical Trial: Multi-center Study of Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse

Brief Summary: The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

Detailed Summary:

The primary objective is to evaluate clinical effectiveness of transvaginal repair with mesh (Uphold LITE) against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Uphold LITE-related complications and subject reported outcomes.

The primary endpoint of the study is to achieve superiority of transvaginal repair with mesh (Uphold LITE) over native tissue repair at 36 months as compared to baseline. Success will be based on a composite of objective and subjective measures.

Additionally, a co-primary endpoint of the study is to achieve non-inferiority of transvaginal repair with mesh (Uphold LITE) to native tissue repair for safety by comparing rates of serious device or serious procedure related complications between baseline and the 36 month time point.

The secondary endpoints of the study include assessments of complications and subject reported outcomes.


Sponsor: Boston Scientific Corporation

Current Primary Outcome: The primary endpoint will be based on anatomic success measured by Pelvic Organ Prolapse Quantification System (POP-Q) for the target compartment at 36 months. [ Time Frame: 36 Months ]

Success will be based on a composite of objective and subjective measures. Also, a co-primary endpoint of the study is to achieve non-inferiority of mesh to native tissue repair for safety by comparing rates of serious device or serious procedure-related complications between baseline and the 36 month time point.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Boston Scientific Corporation

Dates:
Date Received: July 18, 2013
Date Started: October 2013
Date Completion: December 2019
Last Updated: April 12, 2017
Last Verified: April 2017