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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Western Galilee Hospital-Nahariya.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01392651
First received: June 27, 2011
Last updated: July 23, 2011
Last verified: July 2011
  Purpose

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
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 ] [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: January 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with urinary stress incontinence

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392651

Contacts
Contact: Menahem Neuman, MD 0546444033 mneuman@netvision.net.il

Locations
Israel
Department of Obstetrics and Gynecology, Western Galilee Hospital Recruiting
Nahariya, Israel
Sub-Investigator: Jacob Bornstein, MD, MPA         
Sub-Investigator: Vladimir Sosnovsky, MD         
Sub-Investigator: Rene Tendler, MD         
Sub-Investigator: Mohamed Kais, MD         
Clinics of Dr Neuman Recruiting
Rishon Lezion, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

No publications provided

Responsible Party: Dr. Menahem Neuman, Dpt. Obstetrics & Gynecology, Western Galilee Hospital, Nahariya, Israel
ClinicalTrials.gov Identifier: NCT01392651     History of Changes
Other Study ID Numbers: 920090039
Study First Received: June 27, 2011
Last Updated: July 23, 2011
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 23, 2014