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Xenform Postmarket Surveillance Study — Xenform  

Pelvic Organ Prolapse Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01945580
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date February 10, 2014
Completion date February 12, 2020
View Details
See also
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