Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451796
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-28
Brief Title:
Investigation of Novel Non-CE Marked Catheter
Sponsor:
MagCath
Organization:
MagCath
Study Overview
Official Title:
A Urethral Valve Catheter for the Treatment of Women With Stress Urinary Incontinence SUI
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
Hypothesis Treatment with the hydrophilic coated valved intraurethral catheter up to 16 hours per day is effective well tolerated and seemingly safe for treatment of women with stress incontinence
Test persons Ten to twenty stress incontinent women Treatment time Up to two weeks
Test persons Ten to twenty stress incontinent women Treatment time Up to two weeks
Detailed Description:
Demonstrate ease and comfort of device insertion indwelling and removal Patient acceptability during use
Other
Symptom and QOL questionnaire
Drop out analysis
Is the patient motivated to continue using the valve catheter
Is the patient motivated to recommend the valve catheter to other stress incontinent women
Other
Symptom and QOL questionnaire
Drop out analysis
Is the patient motivated to continue using the valve catheter
Is the patient motivated to recommend the valve catheter to other stress incontinent women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None