A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Completed · Phase 3

Conditions studied: Urinary Incontinence

In brief

This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in participants who successfully completed Study 191622-120 (NCT01852045).

Key facts

Study ID

NCT01852058

Run by

Allergan

People needed

95

Starts

2014-01-11

Expected to finish

2019-10-03

Last updated by the study team

2020-05-12

Who can join

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

You may qualify if…

• Successfully completed participation in Study 191622-120
• Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120
• Regularly using clean intermittent catheterization to empty the bladder

You may not qualify if…

• Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
• 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 for any other condition since entering study 191622-120

Where it is running

• University of Alabama at Birmingham Division of Urology Research Office — 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
• St. Louis Children's Hospital Division of Urology — 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 — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center Cincinnati Center for Clinical Research and Outpatient Clinic — Cincinnati, Ohio, United States
• Oklahoma Children's Hospital — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Children's Hospital of Wisconsin Department of Pediatric Urology — Milwaukee, Wisconsin, United States
• UZ Antwerpen — Antwerp, Belgium
• Ghent University Hospital — 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 - Hôpital Mère et l'Enfant — Limoges, France
• Hôpital Necker Enfants-Malades — Paris, France
• Seconda Università di Napoli — Naples, Italy

Full record on ClinicalTrials.gov

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