NCT01917968

Uphold LITE Post-Market Surveillance Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	Uphold Lightweight Vaginal Support System	Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
PROCEDURE	Traditional native tissue repair	Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy

Timeline

• Start date: 2013-10-10
• Primary completion: 2020-02-12
• Completion: 2020-02-12
• First posted: 2013-08-07
• Last updated: 2021-05-20
• Results posted: 2021-03-15

Locations

28 sites across 1 country: United States