NCT04115605

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

A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 599 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Urinary Incontinence, Stress

Interventions

Type	Name	Description
DEVICE	Altis Single Incision Sling	Minimally invasive system including permanently implantable synthetic suburethral sling for the surgical treatment of female Stress Urinary Incontinence

Timeline

• Start date: 2015-04-27
• Primary completion: 2021-09-22
• Completion: 2023-09-22
• First posted: 2019-10-04
• Last updated: 2022-03-28

Locations

33 sites across 5 countries: Belgium, France, Germany, Italy, Spain