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

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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
13
sites
Tarrytown, New York 10591
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Anchorage, AK
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Birmingham, Alabama 35233
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Birmingham, AL
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Charlotte, North Carolina 28203
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Charlotte, NC
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Cleveland, OH
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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Orange, California 92868
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Orange, CA
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Orlando, FL
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Raleigh, North Carolina 27607
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Raleigh, NC
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Randwick, New South Wales 2031
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Randwick,
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Royal Oak, MI
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Saint Louis, MO
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Wyoming, Michigan 49519
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Wyoming, MI
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