Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-13 @ 9:44 PM
Study NCT ID:
NCT04115605
Status:
UNKNOWN
Last Update Posted:
2022-03-28
First Post:
2015-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence
Sponsor:
Coloplast A/S
Organization:
Study Overview
Official Title:
A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 36 months post device implantation in women with stress urinary incontinence.
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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: