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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02161159
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : April 18, 2016
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Urinary Incontinence Urinary Bladder, Overactive Biological: botulinum toxin Type A

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Study Type : Observational
Actual Enrollment : 515 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients With Urinary Incontinence Due to iOAB
Patients with urinary incontinence due to iOAB treated with BOTOX® in accordance with physician standard practice.
Biological: botulinum toxin Type A
botulinum toxin Type A administered in accordance with physician standard practice.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA

Primary Outcome Measures :
  1. Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS) [ Time Frame: Baseline, Week 12 ]
  2. Change From Baseline in Number of Urinary Incontinence Episodes [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures :
  1. Time to Re-Injection of BOTOX® [ Time Frame: 12 Months ]
  2. Number of Nocturia Episodes [ Time Frame: 12 Months ]
  3. Usage of Incontinence Support Products [ Time Frame: 12 Months ]
  4. Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence [ Time Frame: Baseline, 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Urinary Incontinence Due to iOAB

Inclusion Criteria:

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

Exclusion Criteria:

  • Treatment with any botulinum toxin Type A within 18 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02161159

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Sponsors and Collaborators
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Study Director: Medical Director Allergan
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Allergan Identifier: NCT02161159    
Other Study ID Numbers: MAF/AGN/NS/OAB/002
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents