Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135616
Status:
UNKNOWN
Last Update Posted:
2007-04-30
First Post:
2005-08-25
Brief Title:
Treatment of Female Stress Urinary Incontinence Study Comparing Two Suburethral Slings Retropubic Approach TVT and Trans-Obturator TVT-O Approach
Sponsor:
Hopital Antoine Beclere
Organization:
Hopital Antoine Beclere
Study Overview
Official Title:
Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence TVT and TVT-O
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence TVT and TVT-O
Detailed Description:
Urinary stress incontinence USI is a frequent pathology in women Surgical treatment is required in 30 to 50 of women presenting with USI Several surgical techniques are currently available
At the present time the placement of suburethral slings is one of the most efficient techniques Furthermore the placement of a suburethral sling is known to be associated with a low rate of complications
Currently two approaches are available for the placement of a suburethral sling retropubic approach TVT and trans-obturator approach TVT-O The efficacy of these two approaches seem equivalents However the morbidity related to these two techniques is probably different In retrospective studies the retropubic approach is associated with a higher rate of bladder perforation On the other hand the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain
Thus the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence TVT and TVT-O
At the present time the placement of suburethral slings is one of the most efficient techniques Furthermore the placement of a suburethral sling is known to be associated with a low rate of complications
Currently two approaches are available for the placement of a suburethral sling retropubic approach TVT and trans-obturator approach TVT-O The efficacy of these two approaches seem equivalents However the morbidity related to these two techniques is probably different In retrospective studies the retropubic approach is associated with a higher rate of bladder perforation On the other hand the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain
Thus the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence TVT and TVT-O
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