OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients

Status:	Recruiting
Conditions:	Overactive Bladder, Urology
Therapuetic Areas:	Gastroenterology, Nephrology / Urology
Healthy:	No
Age Range:	12 - 17
Updated:	3/29/2019
Start Date:	May 23, 2014
End Date:	April 28, 2022
Contact:	Clinical Trials Registry Team
Email:	IR-CTRegistration@Allergan.com
Phone:	1-877-277-8566

This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) for the
treatment of urinary incontinence due to overactive bladder in pediatric patients between the
ages of 12 to 17 years who have not been adequately managed with anticholinergics.

Inclusion Criteria:

- Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for
at least 6 months

- OAB symptoms not adequately managed by 1 or more anticholinergic agents

Exclusion Criteria:

- OAB caused by a neurological condition

- Use of anticholinergics or other medications to treat OAB symptoms within 7 days

- Current use of indwelling catheter or 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

We found this trial at

sites

Pediatric Urology Associates PC

Tarrytown, New York 10591

from

Tarrytown, NY