Urinary Incontinence
Conditions
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.
Interventions
BIOLOGICALbotulinum toxin Type A
botulinum toxin Type A (BOTOX®) prescribed as standard of care in clinical practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Anticholinergic Drug Use | Baseline, 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BOTOX® Patients with incontinence from NDO due to spinal injury or MS prescribed BOTOX® (Botulinum toxin Type A) as standard of care in clinical practice. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | BOTOX® |
|---|---|
| Age, Continuous | 44.5 Years STANDARD_DEVIATION 16 |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 4 / 55 |
Outcome results
Primary
Change From Baseline in Anticholinergic Drug Use
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.
Time frame: Baseline, 9 Months
Population: Treatment responders for whom pharmacy data is available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BOTOX® | Change From Baseline in Anticholinergic Drug Use | Baseline | 305.21 Doses of Anticholinergic Drugs | Standard Error 36.94 |
| BOTOX® | Change From Baseline in Anticholinergic Drug Use | 9 Months | 199.77 Doses of Anticholinergic Drugs | Standard Error 40.46 |