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A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence

2019-10-10 09:39:43 | BioPortfolio

Summary

The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.

Description

This project has been launched after the introduction of Altis in Europe. This study is a multicenter prospective, observational (i.e. naturalistic) post-marketing clinical follow-up of women for who stress urinary incontinence was diagnosed and will be treated with Altis Single Incision Sling System. Therefore these patients will be asked to allow to use their clinical data and answer some questionnaires. The patients'data will be collected in routine clinical practice before, during and after surgery until 12 months. Then, questionnaires will be mailed to the participants annually during 2 additional years.

Study Design

Conditions

Urinary Incontinence, Stress

Intervention

Altis Single Incision Sling

Location

UZ Leuven
Leuven
Belgium
3000

Status

Recruiting

Source

Coloplast A/S

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-10T09:39:43-0400

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PubMed Articles [13333 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

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