TVT Worldwide Registry

NCT ID: NCT00453739

Last Updated: 2014-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1407 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Robinson, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

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Southern California Permanente Medical Group

Downey, California, United States

Site Status

Milestone Medical Research

Englewood, Colorado, United States

Site Status

Specialists in Urology

Naples, Florida, United States

Site Status

Illinois Urogynecology LTD

Oak Lawn, Illinois, United States

Site Status

Michigan Institute of Women's Health

Dearborn, Michigan, United States

Site Status

Women's Health Center of West Michigan

Grand Rapids, Michigan, United States

Site Status

Female Pelvic Medicine & Reconstructive Surgery

Minneapolis, Minnesota, United States

Site Status

Sheldon J. Freedman MD

Las Vegas, Nevada, United States

Site Status

University of Rochester OB/Gyn Department

Rochester, New York, United States

Site Status

Seton Center, Good Samaritan Hospital

West Chester, Ohio, United States

Site Status

The Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, United States

Site Status

Advanced Clinical Concepts

West Reading, Pennsylvania, United States

Site Status

Vanderbilt University Medical School

Nashville, Tennessee, United States

Site Status

Northern Virginia Pelvic Surgery Associates

Annandale, Virginia, United States

Site Status

Sound Urological Associates

Edmonds, Washington, United States

Site Status

The Townsville Hospital Department of Urogynaecology

Douglas, , Australia

Site Status

Gold Coast Health Service

Southport, , Australia

Site Status

Queen Elizabeth Hospital

Woodville, , Australia

Site Status

Abteilung fuer Gynaekologie

Mödling, , Austria

Site Status

Wentworth-Limeridge Medical Centre

Hamilton, Ontario, Canada

Site Status

Universitatsfrauenklinik

Tübingen, , Germany

Site Status

Kandang Kerbau Women's and Children's Hospital

Singapore, , Singapore

Site Status

Kingsbury House

Cape Town, , South Africa

Site Status

Pretoria Urology Hospital

Hatfield, , South Africa

Site Status

Arwyp Hospital

Kempton, , South Africa

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Ulster Hospital Belfast

Belfast, , United Kingdom

Site Status

Stoke Mandeville Hospital

Buckinghamshire, , United Kingdom

Site Status

Glasgow Southern General

Glasgow, , United Kingdom

Site Status

Leicester General Hospital

Leicester, , United Kingdom

Site Status

Countries

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United States Australia Austria Canada Germany Singapore South Africa South Korea United Kingdom

References

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Tincello DG, Botha T, Grier D, Jones P, Subramanian D, Urquhart C, Kirkemo A, Khandwala S; TVT Worldwide Registry Investigators. The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women. J Urol. 2011 Dec;186(6):2310-5. doi: 10.1016/j.juro.2011.07.078. Epub 2011 Oct 20.

Reference Type RESULT
PMID: 22014817 (View on PubMed)

Other Identifiers

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300-06-006

Identifier Type: -

Identifier Source: org_study_id

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