Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003987

Trial Description

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Title

TVT-World Wide Observational Registry for Long-Term Data

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00003987
  •   2012/06/18
  •   2007/03/28
  •   no
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Secondary IDs

  •   NCT00453739  (ClinicalTrials.gov)
  •   300-06-006  (Ethicon, Inc.)
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Health Condition or Problem studied

  •   Stress Urinary Incontinence
  •   R32 -  Unspecified urinary incontinence
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Standing cough stress test; time frame: 12 months

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Secondary Outcome

- I-QOL score; time frame: 3, 6, 12 and 24 months

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Countries of Recruitment

  •   Australia
  •   Austria
  •   Canada
  •   Germany
  •   Korea, Republic of
  •   Singapore
  •   South Africa
  •   United Kingdom
  •   United States
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Locations of Recruitment

  •  
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Recruitment

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  •   2007/02/27
  •   1407
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion Criteria:

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

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Exclusion Criteria

[---]*

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Ethicon, Inc.
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    • Ethicon, Inc.
    • David Robinson, MD 
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    •   [---]*
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  • start of 1:1-Block address public-contact
    • Ethicon, Inc.
    • David Robinson, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2010/06/01
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Trial Publications, Results and other Documents

  •   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.; 22014817
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.