Phase 3
Completed N=144
Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)
Source: ClinicalTrials.gov NCT01600716 ↗Enrolled (actual)
144
Serious AEs
5.0%
Results posted
Mar 2016
Primary outcomePrimary: Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes — 4.18; 4.32; -3.34; -1.10 Episodes
◆ Published Evidence
Established
25citations · ~3 / year
Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS.
Summary
This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.
Linked Publications
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Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes |
4.18; 4.32; -3.34; -1.10 | — |
| SECONDARY Change From Baseline in Maximum Cystometric Capacity (MCC) |
246.4; 245.7; 127.2; -1.8 | — |
| SECONDARY Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) |
35.9; 36.1; -19.6; 3.7 | — |
| SECONDARY Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score |
32.43; 34.24; 40.39; 9.92 | — |
Eligibility Criteria
Inclusion Criteria
- At least 3 episodes of urinary incontinence over a 3-day period
- History of Multiple Sclerosis (MS)
- Urinary incontinence not adequately controlled by anticholinergic medication
Exclusion Criteria
- Current use of intermittent catheter or indwelling catheter to manage urinary incontinence
- Previous or current botulinum toxin therapy of any serotype for any urological condition
- Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis
Data sourced from ClinicalTrials.gov (NCT01600716) and the linked publication. 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.