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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01392651
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Urinary Stress Incontinence

Study Design

Study Type : Observational
Actual Enrollment : 200 participants
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)
Study Start Date : January 2009
Primary Completion Date : January 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Women with urinary stress incontinence


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392651


Locations
Israel
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
ClinicalTrials.gov Identifier: NCT01392651     History of Changes
Other Study ID Numbers: 920090039
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2011

Keywords provided by menahem neuman, Western Galilee Hospital-Nahariya:
Urinary stress incontinence
TVT

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms