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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02673047
Acronym
BOREAL
Enrollment
474
Registered
2016-02-03
Start date
2016-02-29
Completion date
2016-08-31
Last updated
2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Neurogenic, Urinary Bladder, Overactive

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.

Interventions

BIOLOGICALbotulinum toxin Type A

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

Sponsors

Allergan
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

-Patients not residing in France.

Design outcomes

Primary

MeasureTime frame
Target Patients Prescribed Botox® in Clinical PracticeDay 1

Secondary

MeasureTime frame
Characteristics of PatientsDay 1
Number of Patients by Pathology HistoryDay 1
Number of Patients by Medical and Surgical HistoryDay 1
Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive PatientsDay 1
Percentage of Continent Patients in Non-naive PatientsDay 1
Treatments Previously PrescribedDay 1
Number of Sites InjectedDay 1
Characteristics of Injector PhysiciansDay 1
Types of Anaesthesia and Antibiotic Prophylaxis UsedDay 1
Cytobacteriological Examination of the UrineDay 1
Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®)Day 1
Length of Botox® Treatment in Non-naive PatientsDay 1
Time Since Last Botox® Injection in Non-naive PatientsDay 1
Characteristics of Injector Sites (Locations)Day 1
Number of Adverse Events during the VisitDay 1
Total Dose of Botox® UsedDay 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026