Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00904969
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2009-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Sponsor:
American Medical Systems
Organization:
Study Overview
Official Title:
A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2017-01
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:
AMS051
Brief Summary:
The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.
Detailed Description:
A multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionnaire). Intra-operative procedural data will be collected.
Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status.
Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status.
Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
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?: