Clincosm LogoSign in Get a demo

TVT Worldwide Registry

Sponsor
Ethicon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00453739
Collaborator
(none)
1,407
Enrollment
30
Locations
40
Duration (Months)
46.9
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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 :
    Feb 1, 2007
    Actual Primary Completion Date :
    Jun 1, 2010
    Actual Study Completion Date :
    Jun 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. Standing cough stress test [12 months]

    Secondary Outcome Measures

    1. I-QOL score [3, 6, 12 and 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Southern California Permanente Medical Group Downey California United States 91101
    2 Milestone Medical Research Englewood Colorado United States 80112
    3 Specialists in Urology Naples Florida United States 34102
    4 Illinois Urogynecology LTD Oak Lawn Illinois United States 60453
    5 Michigan Institute of Women's Health Dearborn Michigan United States 48124
    6 Women's Health Center of West Michigan Grand Rapids Michigan United States 49503
    7 Female Pelvic Medicine & Reconstructive Surgery Minneapolis Minnesota United States 55403
    8 Sheldon J. Freedman MD Las Vegas Nevada United States 89148
    9 University of Rochester OB/Gyn Department Rochester New York United States 14642
    10 Seton Center, Good Samaritan Hospital West Chester Ohio United States 45069
    11 The Institute for Female Pelvic Medicine and Reconstructive Surgery Allentown Pennsylvania United States 18104
    12 Advanced Clinical Concepts West Reading Pennsylvania United States 19611
    13 Vanderbilt University Medical School Nashville Tennessee United States 37232
    14 Northern Virginia Pelvic Surgery Associates Annandale Virginia United States 22003
    15 Sound Urological Associates Edmonds Washington United States 98026
    16 The Townsville Hospital Department of Urogynaecology Douglas Australia
    17 Gold Coast Health Service Southport Australia
    18 Queen Elizabeth Hospital Woodville Australia
    19 Abteilung fuer Gynaekologie Moedling Austria
    20 Wentworth-Limeridge Medical Centre Hamilton Ontario Canada L9A 5H4
    21 Universitatsfrauenklinik Tubingen Germany 72076
    22 Samsung Medical Center Seoul Korea, Republic of 135-710
    23 Kandang Kerbau Women's and Children's Hospital Singapore Singapore 229 899
    24 Kingsbury House Cape Town South Africa 7708
    25 Pretoria Urology Hospital Hatfield South Africa 0028
    26 Arwyp Hospital Kempton South Africa 1620
    27 Ulster Hospital Belfast Belfast United Kingdom
    28 Stoke Mandeville Hospital Buckinghamshire United Kingdom HP21 8AL
    29 Glasgow Southern General Glasgow United Kingdom G51 4TF
    30 Leicester General Hospital Leicester United Kingdom LE5 4PW

    Sponsors and Collaborators

    • Ethicon, Inc.

    Investigators

    • Study Director: David Robinson, MD, Ethicon, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ethicon, Inc.
    ClinicalTrials.gov Identifier:
    NCT00453739
    Other Study ID Numbers:
    • 300-06-006
    First Posted:
    Mar 29, 2007
    Last Update Posted:
    May 6, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Urinary Incontinence
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of May 6, 2014