At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 114 enrolled
Drug / intervention
OnabotulinumtoxinAbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
In Brief
A Phase 3 clinical trial evaluating OnabotulinumtoxinA for Urinary Incontinence. Completed, enrolled 114 participants across 31 sites in 8 countries.
Detailed Summary
This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence
CountriesBelgium, Canada, Czechia, France, Italy, Poland, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJul 2013
Primary CompletionOct 2018
TodayJul 2026
First PostedMay 13, 2013
Enrollment StartJul 2, 2013
Primary CompletionOct 11, 2018
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 13.1 years ago
Interventions
OnabotulinumtoxinAbiological
OnabotulinumtoxinA injected into the detrusor wall on Day 1.