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TVT Worldwide Registry

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ClinicalTrials.gov Identifier: NCT00453739
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Stress Urinary Incontinence

Detailed Description:
Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System

Study Design

Study Type : Observational
Actual Enrollment : 1407 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TVT-World Wide Observational Registry for Long-Term Data
Study Start Date : February 2007
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Standing cough stress test [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. I-QOL score [ Time Frame: 3, 6, 12 and 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).
Contacts and Locations

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): NCT00453739


  Show 30 Study Locations
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: David Robinson, MD Ethicon, Inc.
More Information

Publications:
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00453739     History of Changes
Other Study ID Numbers: 300-06-006
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

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