NCT01945580

Xenform Postmarket Surveillance Study

A Prospective, Non-Randomized, Parallel Cohort, Multi-Center Study of Xenform vs. Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare transvaginal repair with a biologic graft 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 Xenform against traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Xenform-related complications and subject reported outcomes. The primary endpoint of the study is to achieve non-inferiority of transvaginal repair with Xenform 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 Xenform 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
PROCEDURE	Prolapse Repair	Transvaginal anterior/apical pelvic organ prolapse repair

Timeline

• Start date: 2014-02-10
• Primary completion: 2020-02-12
• Completion: 2020-02-12
• First posted: 2013-09-18
• Last updated: 2021-04-14
• Results posted: 2021-04-14

Locations

25 sites across 1 country: United States