Phase 3
Completed N=275
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Source: ClinicalTrials.gov NCT00461292 ↗Enrolled (actual)
275
Serious AEs
21.5%
Results posted
Oct 2011
Primary outcomePrimary: Change From Baseline in Number of Weekly Episodes of Urinary Incontinence — 31.2; 32.5; 36.7; -19.4 Number of Weekly Episodes
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Number of Weekly Episodes of Urinary Incontinence |
31.2; 32.5; 36.7; -19.4; -21.8; -13.2 | — |
| SECONDARY Change From Baseline in Maximum Cystometric Capacity (MCC) |
246.8; 247.3; 249.4; 157.2; 157.0; 6.5 | — |
| SECONDARY Change From Baseline in Maximum Detrusor Pressure (MDP) |
42.1; 51.7; 41.5; -26.9; -28.5; 6.4 | — |
| SECONDARY Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire |
36.32; 37.46; 35.72; 24.26; 24.43; 11.71 | — |
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 or 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 (NCT00461292). 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.