Phase 3
N=548
Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00910520 ↗Enrolled (actual)
548
Serious AEs
5.9%
Results posted
Mar 2013
Primary outcome: Primary: Change From Baseline in Number of Daily Episodes of Urinary Incontinence — 5.52; 5.70; -2.95; -1.03 Incontinence episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- onabotulinumtoxinA (Biological); normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Number of Daily Episodes of Urinary Incontinence |
5.52; 5.70; -2.95; -1.03 | — |
| SECONDARY Change From Baseline in Number of Daily Micturition Episodes |
12.01; 11.77; -2.56; -0.83 | — |
| SECONDARY Change From Baseline in Volume Voided Per Micturition |
144.2; 152.5; 43.0; 12.6 | — |
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.
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 (NCT00910520). 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.