An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder
Completed
- Conditions
- Urinary IncontinenceUrinary Bladder, Overactive
- Registration Number
- NCT02161159
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 515
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (53)
David Brix
🇩🇪Bad Mergentheim, Germany
Urologie Turmschtraße
🇩🇪Berlin, Germany
Uwe-Carsten
🇩🇪Berlin, Germany
Albrecht Kastein
🇩🇪Berlin, Germany
ATURO
🇩🇪Berlin, Germany
MVZ Burgdorf
🇩🇪Burgdorf, Germany
Ev.-Luth. Diakonissenanstalt Dresden
🇩🇪Dresden, Germany
Stefan Carl
🇩🇪Emmendingen, Germany
Zentrum für Urologie FFM
🇩🇪Frankfurt, Germany
Georg-August-Universität Göttingen
🇩🇪Göttingen, Germany
Scroll for more (43 remaining)David Brix🇩🇪Bad Mergentheim, Germany