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)
What it found
The main measure showed a statistically significant benefit.
“OnabotulinumtoxinA vs placebo significantly reduced UI at week 6 (-3.3 episodes/day vs -1.1 episodes/day, p < 0.001; primary endpoint).”Read by software from the paper's abstract
week 6
| Group | n | Value |
|---|---|---|
| onabotulinumtoxinA 100 U | 66 | -3.3 episodes/day |
| placebo | 78 | -1.1 episodes/day |
p = < 0.001
Read by software from the paper's abstract
What was tested
Treatment tested
- Onabotulinumtoxina
Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor
- Botulinum toxin type a
Synaptosomal nerve-associated protein 25 (SNAP-25) hydrolytic enzyme
Placebo or sham
- Placebo (Normal Saline)
Results by group
Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
Baseline, Week 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| OnabotulinumtoxinA | 4.18 Episodes | 3.167 (Standard Deviation) | 66 |
| Placebo (Normal Saline) | 4.32 Episodes | 2.422 (Standard Deviation) | 78 |
| OnabotulinumtoxinA | -3.34 Episodes | 2.881 (Standard Deviation) | 66 |
| Placebo (Normal Saline) | -1.10 Episodes | 2.083 (Standard Deviation) | 78 |
OnabotulinumtoxinA
Placebo (Normal Saline)
OnabotulinumtoxinA
Placebo (Normal Saline)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| OnabotulinumtoxinA Treatment Cycle 1 | 66 | 7 (10.6%) | |
| Placebo (Normal Saline) | 78 | 3 (3.8%) | |
| OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2 | 30 | 0 (0.0%) | |
| Placebo (Normal Saline)/OnabotulinumtoxinA | 67 | 2 (3.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
Baseline, Week 6
Bladder, bowel and sexual functionThe primary efficacy measure is the number of episodes of urinary incontinence as recorded by the patient in the 3 day bladder diary completed in the week prior to each study visit.
Bladder, bowel and sexual function
Other measures (4)
Change From Baseline in Maximum Cystometric Capacity (MCC)
Baseline, Week 6
Bladder, bowel and sexual functionChange From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)
Baseline, Week 6
Bladder, bowel and sexual functionChange From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Baseline, Week 6
Bladder, bowel and sexual functionQuality of life (reported by participants)- Maximum Cystometric Capacity (MCC, mL) by urodynamics as determined by the independent central reviewer
Who could take part
MS (type not specified) · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS.Neurology · 2018
OnabotulinumtoxinA vs placebo significantly reduced UI at week 6 (-3.3 episodes/day vs -1.1 episodes/day, p < 0.001; primary endpoint).
Read by software from the paper's abstract
Loading reviews and guidelines…
Related trials
- ICE Trial
Phase 4 · Ongoing (inferred)
Still running
- A Study to Investigate Arbaclofen ER Tablets for the Trea…
Phase 3 · Not yet recruiting
Still running
- Silodosin for Urinary Symptoms in Female Patients With Mu…
Phase 4 · Recruiting
Still running
- Cannabis (THC vs. CBD) in Multiple Sclerosis
Phase 2 · Recruiting
Still running
- ICE
Phase 4 · Recruiting
Still running
- ALPHA-SEP
Not a drug-phase study · Status unknown
No result found
History
Started
Jun 2012
Main results due
Apr 2014
Finished
Mar 2015
Results posted
Mar 2016
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error