Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Status Completed

Clinical Trial Summary

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

Clinical Trial Description

This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02348112
Study type	Observational
Source	Coloplast A/S
Contact
Status	Completed
Phase
Start date	January 2015
Completion date	September 2021

View Details

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