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The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence — EASY  

Stress Urinary Incontinence Clinical Trial

Official title:
The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence

Clinical Trial Summary

This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence

Clinical Trial Description

This study is a prospective, European Post-Market, one non-controlled arm, multi-centre clinical trial conducted at up to 10 centers in Europe. It is designed to get more clinical information for users (uro-gynecologists) of the Altis Single Incision Sling System for female stress urinary incontinence treatment in terms of objective and subjective cure rate, quality of life improvement, patient satisfaction and safety, especially in long term follow-up (3 years). Clinical data will be collected at baseline, implantation procedure, post-operative at 6 weeks, 6 months, 1, 2 and 3 years ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02049840
Study type Interventional
Source Coloplast A/S
Contact
Status Completed
Phase N/A
Start date December 16, 2013
Completion date July 21, 2021
View Details
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