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

Completed · Phase 3

Conditions studied: Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT01852045

Run by

Allergan

People needed

114

Starts

2013-07-02

Expected to finish

2018-10-11

Last updated by the study team

2019-11-21

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• William Beaumont Hospital Research Institute — Royal Oak, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Pediatric Urology Associates, PC — Tarrytown, New York, United States
• McKay Urology Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Health System — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Oklahoma Childrens Hospital — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• UZ Antwerpen — Antwerp, Belgium
• UZ Gent , Urology — Ghent, Belgium
• UZ Leuven — Leuven, Belgium
• McMaster University Medical Centre — Hamilton, Ontario, Canada
• CHU Sainte-Justine — Montreal, Quebec, Canada
• Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia
• Fakultni nemocnice Olomouc — Olomouc, Czechia
• Hopital Pellegrin - Enfants — Bordeaux, France
• CHU de Limoges - Hopital Mere et l'Enfant — Limoges, France
• Hopital Trousseau — Paris, France
• Necker Enfants Malades Hospital — Paris, France

Full record on ClinicalTrials.gov

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