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NCT Number: NCT02673047

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

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.

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site D'Aix En Provence, Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-Patients not residing in France.

Treatment and study plan

Botulinum toxin type A

Biological

Botulinum toxin Type A (Botox®) injection as prescribed as standard of care in clinical practice.

Other names: Botox®, onabotulinumtoxinA

Primary outcomes

  1. Target Patients Prescribed Botox® in Clinical Practice

    Time frame: Day 1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Acronym: BOREAL

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2016
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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