Phase 3
Completed N=557
Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Source: ClinicalTrials.gov NCT00910845 ↗Enrolled (actual)
557
Serious AEs
6.2%
Results posted
Mar 2013
Primary outcomePrimary: Change From Baseline in Number of Daily Episodes of Urinary Incontinence — 5.47; 5.09; -2.65; -0.87 Incontinence episodes
Summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Number of Daily Episodes of Urinary Incontinence |
5.47; 5.09; -2.65; -0.87 | — |
| SECONDARY Change From Baseline in Number of Daily Micturition Episodes |
11.98; 11.20; -2.15; -0.91 | — |
| SECONDARY Change From Baseline in Volume Voided Per Micturition |
156.4; 161.1; 41.1; 9.7 | — |
Eligibility Criteria
Inclusion Criteria
- Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
- Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
Exclusion Criteria
- Overactive Bladder caused by neurological condition
- Patient has predominance of stress incontinence
- History or evidence of pelvic or urological abnormality
Data sourced from ClinicalTrials.gov (NCT00910845). 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. Informational only — not medical advice.