Phase 2
N=313
A Research Study for Patients With Overactive Bladder
Overactive Bladder · Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00168454 ↗Enrolled (actual)
313
Serious AEs
—
Results posted
Feb 2010
Primary outcome: Primary: Change in Number of Urinary Urge Incontinence Episodes — 32.5; 30.3; 27.8; 28.3 episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- botulinum toxin Type A (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Urinary Urge Incontinence Episodes |
32.5; 30.3; 27.8; 28.3; 24.1; 26.8 | — |
| SECONDARY Change in Number of Micturitions |
73.3; 76.3; 80.3; 76.5; 76.7; 75.6 | — |
| SECONDARY Change in Number of Nocturia Episodes |
12.3; 12.2; 13.9; 17.9; 12.2; 14.9 | — |
| SECONDARY Maximum Cystometric Capacity (MCC) by Urodynamic Measurements |
267.1; 262.9; 255.0; 258.4; 280.1; 271.7 | — |
| SECONDARY Incontinence Quality of Life Instrument (I-QOL) |
35.9; 32.3; 34.3; 30.5; 32.0; 34.5 | — |
Summary
The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.
Eligibility Criteria
Inclusion Criteria
- Must be between 18-85 years old
- Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
- Must weigh at least 50 kg (110 lbs)
- Must be willing and able to record information regarding bladder function into a diary (provided)
- Must be willing and able to complete the entire course of the study
Exclusion Criteria
- Cannot currently be catheterizing as a way to control incontinence
- Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition
Data sourced from ClinicalTrials.gov (NCT00168454). 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.