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

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

Urinary Stress Incontinence

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • Prevention of stress incontinence [ Time Frame: 12 months ]
    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.

Secondary Outcome Measures:
  • Evaluation of side effects: tape erosion, pain, bleeding [ Time Frame: 12 months ]
    We will question the women for possible pain, bleeding or vaginal discharge. The data on physical examination will be taken from the file.

Enrollment: 200
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Women with urinary stress incontinence


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with stress urinary incontinence who underwent surgery, by TVT methos, either TVTO or TVTS.

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
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Please refer to this study by its identifier: NCT01392651

Department of Obstetrics and Gynecology, Western Galilee Hospital
Nahariya, Israel
Clinics of Dr Neuman
Rishon Lezion, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

Responsible Party: menahem neuman, Principal Investigator, Western Galilee Hospital-Nahariya Identifier: NCT01392651     History of Changes
Other Study ID Numbers: 920090039
Study First Received: June 27, 2011
Last Updated: July 2, 2014

Keywords provided by Western Galilee Hospital-Nahariya:
Urinary stress incontinence

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms processed this record on April 28, 2017