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TVTO Versus TVTFFM for Urinary Stress Incontinence

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ClinicalTrials.gov Identifier: NCT01392664
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
menahem neuman, Western Galilee Hospital-Nahariya

Brief Summary:
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.

Condition or disease
Urinary Stress Incontinence Treated by TVT

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.

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Retrospective
Study Start Date : February 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. 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.



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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 Urinary Stress Incontinence treated by TVT
Criteria

Inclusion Criteria:

  • Women with Urinary Stress Incontinence treated by TVT

Exclusion Criteria:

  • Women without with Urinary Stress Incontinence or not treated by TVT

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): NCT01392664


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

Responsible Party: menahem neuman, Principal Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01392664     History of Changes
Other Study ID Numbers: 920090040
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016

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