Phase 3 N=114 Randomized Quadruple-blind Treatment

Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients

Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT01852045 ↗

Enrolled (actual)

114

Serious AEs

8.0%

Results posted

Oct 2019

Primary outcome: Primary: Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes — -1.30; -1.30; -1.34 urinary incontinence episodes per day — p=0.9949

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: OnabotulinumtoxinA (Biological)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes	-1.30; -1.30; -1.34	0.9949
SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE)	27; 33; 23	—
SECONDARY Change From Baseline in Average Urine Volume at First Morning Catheterization	21.93; 34.90; 87.49	0.5117
SECONDARY Percentage of Participants With Night Time Urinary Incontinence	0.0; 13.3; 3.6; 13.2; 2.2; 14.3	—
SECONDARY Change From Baseline in Maximum Cystometric Capacity (MCC)	62.06; 48.57; 63.55	0.4948
SECONDARY Percentage of Participants With Involuntary Detrusor Contractions (IDC)	94.4; 88.1; 92.6; 61.8; 44.7; 46.4	0.2027
SECONDARY Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC	-7.64; -12.13; -5.46	0.5524
SECONDARY Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase	-12.88; -20.09; -27.31	0.1737
SECONDARY Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase	9.50; -39.00; 12.00	—
SECONDARY Time to Participant Request for Retreatment	30.6; 24.1; 29.6	—
SECONDARY Time to Participant Qualification for Retreatment	35.0; 25.0; 29.6	—

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.

Eligibility Criteria

Inclusion Criteria

Urinary incontinence due to neurogenic detrusor overactivity
Regularly using clean intermittent catheterization to empty the bladder

Exclusion Criteria

Surgery of the spinal cord within 6 months
Diagnosis of cerebral palsy
Current or planned use of a baclofen pump
Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01852045). 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.