Phase 3
N=416
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00311376 ↗Enrolled (actual)
416
Serious AEs
18.7%
Results posted
Oct 2011
Primary outcome: Primary: Change From Baseline in Number of Weekly Episodes of Urinary Incontinence — 31.1; 32.3; 28.3; -22.7 Number of Weekly Episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- botulinum toxin Type A (200U) (Biological); botulinum toxin Type A (300U) (Biological); Normal Saline (Placebo); botulinum toxin Type A (200U) (Other); Normal Saline (Placebo); botulinum toxin Type A (300U) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Number of Weekly Episodes of Urinary Incontinence |
31.1; 32.3; 28.3; -22.7; -21.0; -8.8 | — |
| SECONDARY Change From Baseline in Maximum Cystometric Capacity (MCC) |
255.8; 252.3; 256.0; 167.7; 151.2; 15.5 | — |
| SECONDARY Change From Baseline in Maximum Detrusor Pressure (MDP) |
47.1; 51.3; 50.9; -33.3; -35.1; -2.4 | — |
| SECONDARY Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire |
32.18; 33.95; 35.06; 32.92; 26.90; 10.81 | — |
Summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
Eligibility Criteria
Inclusion Criteria
- Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
- Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion Criteria
- History of evidence of pelvic or urologic abnormality
- Previous or current diagnosis of bladder or prostate cancer
- Urinary tract infection at time of enrollment
Data sourced from ClinicalTrials.gov (NCT00311376). 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.