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Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium

Completed
Conditions
Urinary Incontinence
Interventions
Biological: botulinum toxin Type A
Registration Number
NCT02072928
Lead Sponsor
Allergan
Brief Summary

This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical practice.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
55
Inclusion Criteria
  • Patients prescribed BOTOX® for urine incontinence from NDO due to spinal injury or MS as standard of care in clinical practice in Belgium
  • Previous treatment with anticholinergic drugs ineffective
  • Last BOTOX® treatment ≥18 months.
Exclusion Criteria
  • Diagnosis of urinary incontinence less than 9 months.
  • No anticholinergic drug use in the last 9 months.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
BOTOX®botulinum toxin Type APatients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice.
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Anticholinergic Drug UseBaseline, 9 Months

Anticholinergic drug use was collected the 9 months before the baseline Botox® treatment and the 9 months following the baseline Botox® treatment. Total anticholinergic drug use in the 9 months following the baseline Botox® treatment is noted.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

CHU de Liège

🇧🇪

Esneux, Belgium

UZA

🇧🇪

Edegem, Belgium

Maria Ziekenhuis Noord-Limburg

🇧🇪

Overpelt, Belgium

Centre Hospitalier Regional de Huy

🇧🇪

HUY, Belgium

UZ Leuven

🇧🇪

Leuven, Belgium

UZ Gent

🇧🇪

Ghent, Belgium

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