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TVTO Versus TVTFFM for Urinary Stress Incontinence

This study has been completed.
Information provided by (Responsible Party):
menahem neuman, Western Galilee Hospital-Nahariya Identifier:
First received: June 29, 2011
Last updated: June 6, 2016
Last verified: June 2016
Women who had urinary stress incontinence and underwent one of two procedures: the classic TVTO or the Folke-Flam method of surgical operation, will be evaluated and compared.

Urinary Stress Incontinence Treated by TVT

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Resolution of urinary stress incontinence [ Time Frame: One year after surgery ]
    We will question the women as for they have stress urinary incontinence. Physical examination data will also be retrieved.

Secondary Outcome Measures:
  • Side effect of surgery [ Time Frame: six-12 months ]
    We will question the women if they have symptoms such as pain in the hip joints, vaginal discharge and bleeding. Physical examination will be retrieved from the charts.

Enrollment: 200
Study Start Date: February 2009
Study Completion Date: July 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Detailed Description:
We will enroll women that underwent one of the two surgeries: TVTO or the modification where the needle passes somewhat to the side to prevent the post operative pain, for urinary stress incontinence. Data will be collected from the charts. Telephone interviews will be carried out. Physical examination will also be incorporated.

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 Urinary Stress Incontinence treated by TVT

Inclusion Criteria:

  • Women with Urinary Stress Incontinence treated by TVT

Exclusion Criteria:

  • Women without with Urinary Stress Incontinence or not treated by TVT
  Contacts and Locations
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Please refer to this study by its identifier: NCT01392664

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

Responsible Party: menahem neuman, Principal Investigator, Western Galilee Hospital-Nahariya Identifier: NCT01392664     History of Changes
Other Study ID Numbers: 920090040
Study First Received: June 29, 2011
Last Updated: June 6, 2016

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 September 20, 2017