Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT01657916
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2012-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
5-Year Objective and Subjective Results of a Mid-Urethral Sling
Sponsor:
Atlantic Health System
Organization:
Study Overview
Official Title:
5-Year Objective and Subjective Results of a Mid-Urethral Sling
Status:
COMPLETED
Status Verified Date:
2017-06
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:
Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.
Detailed Description:
Between June 2007 and December 2008, the investigators performed 155 Align mid-urethral slings in patients who were only receiving this operation. Very few studies have outcomes at 5 years of greater. The aim of this prospective cohort study is to evaluate five-year objective and subjective cure rates. Secondary endpoints will assess failure risk factors and describe any complications of the retropublic Align Urethral Support System five years postoperatively.
Study Oversight
Has Oversight DMC:
True
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?: