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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


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

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