Status:
UNKNOWN
A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence
Lead Sponsor:
Coloplast A/S
Conditions:
Urinary Incontinence, Stress
Eligibility:
FEMALE
18+ years
Brief 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 3...
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 ...
Eligibility Criteria
Inclusion
- Implanted with Altis Single Incision Sling System
Exclusion
- 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.
Key Trial Info
Start Date :
April 27 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 22 2023
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT04115605
Start Date
April 27 2015
End Date
September 22 2023
Last Update
March 28 2022
Active Locations (33)
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1
UZ Leuven
Leuven, Belgium, 3000
2
CHRU Hotel Dieu
Angers, France, 49933
3
Clinique Rhône Durance
Avignon, France, 84082
4
Clinique Champeau Mediterranée
Béziers, France, 34535