Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441454
Status:
COMPLETED
Last Update Posted:
2012-12-11
First Post:
2007-02-28
Brief Title:
Retropubic vs Transobturator Tension-free Vaginal Tape
Sponsor:
Austrian Urogynecology Working Group AUWG
Organization:
Austrian Urogynecology Working Group AUWG
Study Overview
Official Title:
Retropubic vs Transobturator Tension-free Vaginal Tape TVT vs TVT-O A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2012-12
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 so-called tension-free vaginal tape TVT first described in Sweden in 1996 has become a standard operation worldwide for the treatment of women with stress urinary incontinence This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen just above the pubic bone In 2001 a urologist in France proposed passing a similar tape laterally as opposed to behind the pubic bone This tape is passed through a window of the pelvic bones the so-called obturator foramen by what is called a transobturator approach It is passed through the skin of the thigh as opposed to the lower abdomen The reason for this modification was to avoid injuring the bladder and possibly provide a more physiologic restoration of the continence mechanism However it is unclear whether the lateral so-called transobturator approach is as good as or better than the initial approach behind the pubic bone
The purpose of the present study is to compare the standard retropubic and the newer transobturator approach for the placement of a tape for treating women with stress urinary incontinence
The purpose of the present study is to compare the standard retropubic and the newer transobturator approach for the placement of a tape for treating women with stress urinary incontinence
Detailed Description:
After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach
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