Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
menahem neuman, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01392651
First received: June 27, 2011
Last updated: July 2, 2014
Last verified: July 2011

June 27, 2011
July 2, 2014
January 2009
January 2012   (final data collection date for primary outcome measure)
Prevention of stress incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
We will collect data from the files, question the women for possible urinary stress incontinence after one month, 6 months and 12 months after surgery. Data of physical examination will also be incorporated.
Prevention of stress incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
We will question the women for possible urinary stress incontinence after one month, 6 months and 12 months after surgery. Data of physical examination will be collected from the file.
Complete list of historical versions of study NCT01392651 on ClinicalTrials.gov Archive Site
Evaluation of side effects: tape erosion, pain, bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
We will question the women for possible pain, bleeding or vaginal discharge. The data on physical examination will be taken from the file.
Same as current
Not Provided
Not Provided
 
Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI
Outcome of Treatment of Women With Urinary Stress Incontinence Treated by Tension-free-vaginal-tape-obturator (TVTO) Compared to Tension-free-vaginal-tape-Secur (TVTS)

Women with urinary stress incontinence who underwent surgical treatment by either TVTO or TVTS will be enrolled. The investigators will collect data from charts and use a telephone questionnaire to check the outcome of these women. Physical examination findings will also be incorporated.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Women with stress urinary incontinence who underwent surgery, by TVT methos, either TVTO or TVTS.

Urinary Stress Incontinence
Not Provided
Women with urinary stress incontinence
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with USI who underwent TVTS or TVTO procedure, more than 6 months ago

Exclusion Criteria:

  • Women who have not undergone TVT procedure
Female
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01392651
920090039
No
menahem neuman, Western Galilee Hospital-Nahariya
Western Galilee Hospital-Nahariya
Not Provided
Not Provided
Western Galilee Hospital-Nahariya
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP