Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006390

Trial Description

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Title

An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder

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Trial Acronym

GRACE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in
patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms
have not been adequately managed by oral anticholinergic therapy.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006390
  •   2014/11/19
  •   2014/06/09
  •   no
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Secondary IDs

  •   NCT02161159  (ClinicalTrials.gov)
  •   MAF/AGN/NS/OAB/002  (Allergan)
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Health Condition or Problem studied

  •   Urinary Incontinence
  •   Urinary Bladder, Overactive
  •   R32 -  Unspecified urinary incontinence
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Interventions/Observational Groups

  •   Biological: botulinum toxin Type A
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Characteristics

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

- Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS); time frame: Baseline, Week 12
- Change From Baseline in Number of Urinary Incontinence Episodes; time frame: Baseline, Week 12

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Secondary Outcome

- Time to Re-Injection of BOTOX®; time frame: 12 Months
- Number of Nocturia Episodes; time frame: 12 Months
- Usage of Incontinence Support Products; time frame: 12 Months
- Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence; time frame: Baseline, 12 Months

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Countries of Recruitment

  •   Germany
  •   Spain
  •   Sweden
  •   United Kingdom
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Locations of Recruitment

  •  
  •  
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Recruitment

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  •   2014/06/30
  •   500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- No prior treatment with botulinum toxin Type A for treatment of iOAB

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Exclusion Criteria

- Treatment with any botulinum toxin Type A within 18 months

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Addresses

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    • Allergan
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    • Allergan
    • Medical Director 
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    • Allergan Inc. 
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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 ongoing
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Trial Publications, Results and other Documents

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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.