TVT Worldwide Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00453739
First received: March 28, 2007
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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
Stress Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TVT-World Wide Observational Registry for Long-Term Data

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Standing cough stress test [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • I-QOL score [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 1407
Study Start Date: February 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: 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
Study First Received: March 28, 2007
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board
France: Institutional Ethical Committee
United Kingdom: Research Ethics Committee
Austria: Ethikkommission
Germany: Ethics Commission
Italy: Ethics Committee
Finland: Ethics Committee
Spain: Ethics Committee
South Africa: National Health Research Ethics Council
Australia: Human Research Ethics Committee
South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014