N/A
N=55
Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02072928 ↗Enrolled (actual)
55
Serious AEs
7.3%
Results posted
Dec 2017
Primary outcome: Primary: Change From Baseline in Anticholinergic Drug Use — 305.21; 199.77 Doses of Anticholinergic Drugs
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- botulinum toxin Type A (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Anticholinergic Drug Use |
305.21; 199.77 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02072928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.