NCT02049840

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Altis Single Incision Sling System	Altis Single Incision Sling (SIS) System is a permanently implantable synthetic sling for the surgical treatment of Stress Urinary Incontinence

Timeline

• Start date: 2013-12-16
• Primary completion: 2019-11-04
• Completion: 2021-07-21
• First posted: 2014-01-30
• Last updated: 2021-09-28

Locations

13 sites across 5 countries: France, Germany, Italy, Netherlands, Spain