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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
menahem neuman, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT01392651
First received: June 27, 2011
Last updated: July 2, 2014
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.


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)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: menahem neuman, Principal Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT01392651     History of Changes
Other Study ID Numbers: 920090039
Study First Received: June 27, 2011
Last Updated: July 2, 2014
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 July 20, 2014