Urinary Bladder, Overactive, Urinary Incontinence
Conditions
Brief summary
This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms have not been adequately managed by oral anticholinergic therapy.
Interventions
BIOLOGICALbotulinum toxin Type A
botulinum toxin Type A administered in accordance with physician standard practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* No prior treatment with botulinum toxin Type A for treatment of iOAB
Exclusion criteria
* Treatment with any botulinum toxin Type A within 18 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS) | Baseline, Week 12 |
| Change From Baseline in Number of Urinary Incontinence Episodes | Baseline, Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Time to Re-Injection of BOTOX® | 12 Months |
| Number of Nocturia Episodes | 12 Months |
| Usage of Incontinence Support Products | 12 Months |
| Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence | Baseline, 12 Months |
Countries
Germany, Spain, Sweden, United Kingdom
Outcome results
None listed