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Clinical Trials/NCT02673047
NCT02673047
Completed
Not Applicable

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

Allergan50 sites in 1 country474 target enrollmentFebruary 2016
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ConditionsUrinary Bladder, OveractiveUrinary Bladder, Neurogenic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Bladder, Overactive
Sponsor
Allergan
Enrollment
474
Locations
50
Primary Endpoint
Target Patients Prescribed Botox® in Clinical Practice
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
August 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Allergan
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •Patients not residing in France.

Outcomes

Primary Outcomes

Target Patients Prescribed Botox® in Clinical Practice

Time Frame: Day 1

Secondary Outcomes

  • Types of Anaesthesia and Antibiotic Prophylaxis Used(Day 1)
  • Cytobacteriological Examination of the Urine(Day 1)
  • Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®)(Day 1)
  • Length of Botox® Treatment in Non-naive Patients(Day 1)
  • Time Since Last Botox® Injection in Non-naive Patients(Day 1)
  • Characteristics of Injector Sites (Locations)(Day 1)
  • Total Dose of Botox® Used(Day 1)
  • Treatments Previously Prescribed(Day 1)
  • Number of Sites Injected(Day 1)
  • Characteristics of Injector Physicians(Day 1)
  • Characteristics of Patients(Day 1)
  • Number of Patients by Pathology History(Day 1)
  • Number of Patients by Medical and Surgical History(Day 1)
  • Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive Patients(Day 1)
  • Percentage of Continent Patients in Non-naive Patients(Day 1)
  • Number of Adverse Events during the Visit(Day 1)

Study Sites (50)

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