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Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder (BOREAL)

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: NCT02673047
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : October 24, 2016
Information provided by (Responsible Party):

Brief Summary:
This study will describe the prescription conditions of botulinum toxin Type A (Botox®) injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity (NDO) or idiopathic overactive bladder (IOAB) as per standard of care in clinical practice in France.

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

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Study Type : Observational
Actual Enrollment : 474 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : February 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients prescribed botulinum toxin Type A (Botox®) injection for the treatment of urinary incontinence associated with neurogenic detrusor overactivity or overactive bladder as per standard of care in clinical practice.
Biological: botulinum toxin Type A
Botulinum toxin Type A (Botox®) injection as prescribed as standard of care in clinical practice.
Other Names:
  • Botox®
  • onabotulinumtoxinA

Primary Outcome Measures :
  1. Target Patients Prescribed Botox® in Clinical Practice [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Treatments Previously Prescribed [ Time Frame: Day 1 ]
  2. Number of Sites Injected [ Time Frame: Day 1 ]
  3. Total Dose of Botox® Used [ Time Frame: Day 1 ]
  4. Types of Anaesthesia and Antibiotic Prophylaxis Used [ Time Frame: Day 1 ]
  5. Cytobacteriological Examination of the Urine [ Time Frame: Day 1 ]
  6. Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®) [ Time Frame: Day 1 ]
  7. Length of Botox® Treatment in Non-naive Patients [ Time Frame: Day 1 ]
  8. Time Since Last Botox® Injection in Non-naive Patients [ Time Frame: Day 1 ]
  9. Characteristics of Injector Sites (Locations) [ Time Frame: Day 1 ]
  10. Characteristics of Injector Physicians [ Time Frame: Day 1 ]
  11. Characteristics of Patients [ Time Frame: Day 1 ]
  12. Number of Patients by Pathology History [ Time Frame: Day 1 ]
  13. Number of Patients by Medical and Surgical History [ Time Frame: Day 1 ]
  14. Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive Patients [ Time Frame: Day 1 ]
  15. Percentage of Continent Patients in Non-naive Patients [ Time Frame: Day 1 ]
  16. Number of Adverse Events during the Visit [ Time Frame: Day 1 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:   Probability Sample
Study Population
Adult patients treated with Botox® for urinary incontinence associated with NDO or IOAB in clinical practice.

Inclusion Criteria:

-Patients who receive a Botox® injection for urinary incontinence.

Exclusion Criteria:

-Patients not residing in France.

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): NCT02673047

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Sponsors and Collaborators
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Study Director: Medical Director Allergan
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Responsible Party: Allergan Identifier: NCT02673047    
Other Study ID Numbers: MAF/AGN/NS/OAB/006
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Neurologic Manifestations
Nervous System 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