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

Coloplast

Status: Unknown

Conditions: Urinary Incontinence, Stress

Treatments: Device: Altis Single Incision Sling

Study type: Observational

Funder types: Industry

Identifiers

NCT04115605

SU017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 599 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implanted with Altis Single Incision Sling System

Exclusion criteria

• Refuses to be included in the survey or that their medical data will be used for research purposes
• Indication for Altis Single Incision Sling System implantation is not for the treatment of female urinary incontinence.