TVT Worldwide Registry
May 5, 2014 updated by: Ethicon, Inc.
TVT-World Wide Observational Registry for Long-Term Data
The objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape) systems in women with stress urinary incontinence.
Study Overview
Status
Completed
Conditions
Detailed Description
Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System
Study Type
Observational
Enrollment (Actual)
1407
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Douglas, Australia
- The Townsville Hospital Department of Urogynaecology
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Southport, Australia
- Gold Coast Health Service
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Woodville, Australia
- Queen Elizabeth Hospital
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Moedling, Austria
- Abteilung fuer Gynaekologie
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Ontario
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Hamilton, Ontario, Canada, L9A 5H4
- Wentworth-Limeridge Medical Centre
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Tubingen, Germany, 72076
- Universitätsfrauenklinik
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Singapore, Singapore, 229 899
- Kandang Kerbau Women's and Children's Hospital
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Cape Town, South Africa, 7708
- Kingsbury House
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Hatfield, South Africa, 0028
- Pretoria Urology Hospital
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Kempton, South Africa, 1620
- Arwyp Hospital
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Belfast, United Kingdom
- Ulster Hospital Belfast
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Buckinghamshire, United Kingdom, HP21 8AL
- Stoke Mandeville Hospital
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Glasgow, United Kingdom, G51 4TF
- Glasgow Southern General
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Leicester, United Kingdom, LE5 4PW
- Leicester General Hospital
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California
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Downey, California, United States, 91101
- Southern California Permanente Medical Group
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Colorado
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Englewood, Colorado, United States, 80112
- Milestone Medical Research
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Florida
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Naples, Florida, United States, 34102
- Specialists in Urology
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Illinois
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Oak Lawn, Illinois, United States, 60453
- Illinois Urogynecology LTD
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Michigan
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Dearborn, Michigan, United States, 48124
- Michigan Institute of Women's Health
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Grand Rapids, Michigan, United States, 49503
- Women's Health Center of West Michigan
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Minnesota
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Minneapolis, Minnesota, United States, 55403
- Female Pelvic Medicine & Reconstructive Surgery
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Nevada
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Las Vegas, Nevada, United States, 89148
- Sheldon J. Freedman MD
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New York
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Rochester, New York, United States, 14642
- University of Rochester OB/Gyn Department
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Ohio
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West Chester, Ohio, United States, 45069
- Seton Center, Good Samaritan Hospital
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- The Institute for Female Pelvic Medicine and Reconstructive Surgery
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West Reading, Pennsylvania, United States, 19611
- Advanced Clinical Concepts
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical School
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Virginia
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Annandale, Virginia, United States, 22003
- Northern Virginia Pelvic Surgery Associates
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Washington
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Edmonds, Washington, United States, 98026
- Sound Urological Associates
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women diagnosed with SUI who are suitable candidates for a TVT system, according the relevant Instructions for Use (IFU).
Description
Inclusion Criteria:
- Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Standing cough stress test
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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I-QOL score
Time Frame: 3, 6, 12 and 24 months
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3, 6, 12 and 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
March 28, 2007
First Submitted That Met QC Criteria
March 28, 2007
First Posted (Estimate)
March 29, 2007
Study Record Updates
Last Update Posted (Estimate)
May 6, 2014
Last Update Submitted That Met QC Criteria
May 5, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300-06-006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.