Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064662
Status:
COMPLETED
Last Update Posted:
2013-05-10
First Post:
2003-07-10
Brief Title:
Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2013-05
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:
SISTEr
Brief Summary:
The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates yet have not been compared directly to each other in a large rigorously conducted randomized trial The secondary aims of the trial are to compare other outcomes for the two surgical procedures including quality of life sexual function satisfaction with treatment outcomes complications and need for other treatmentsafter surgery Follow-up will be a minimum of two years and up to four years
Detailed Description:
None
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