Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463554
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2007-04-18
Brief Title:
TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence
Sponsor:
Ethicon Inc
Organization:
Ethicon Inc
Study Overview
Official Title:
An Evaluation of the GYNECARE TVT-SECUR System Tension-free Support for Incontinence for the Treatment of Stress Urinary Incontinence Trademark
Status:
COMPLETED
Status Verified Date:
2023-08
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:
The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR System Tension-free Support for Incontinence in women with stress urinary incontinence SUI
Detailed Description:
The primary variable for effectiveness is 50 improvement on the subjective symptom Visual Analog Scale VAS at Visit 3Week 5 35 days post-surgery to be accepted
Study Oversight
Has Oversight DMC:
None
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?:
None