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

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.

Timeline

Start

2013-07-02

Primary completion

2018-10-11

Completion

2018-10-11

Outcome

Missed primary endpoint

registry analysis (superiority test); OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 100 U; p = 0.9949 NCT01852045 ↗

registry analysis (superiority test); OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 200 U; p = 0.9123 NCT01852045 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	50 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	100 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	200 iu	Other

Indications