A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Urinary Incontinence
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Alabama at Birmingham Division of Urology Research Office
- Cedars-Sinai Medical Center
- Children's Hospital of Orange County
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Riley Hospital for Children
- William Beaumont Hospital Research Institute
- St. Louis Children's Hospital Division of Urology
- Pediatric Urology Associates, PC
- McKay Urology Carolinas Medical Center
- Duke University
- Cincinnati Children's Hospital Medical Center Cincinnati Center for Clinical Research and Outpatient Clinic
- Oklahoma Children's Hospital
- Medical University of South Carolina
- Children's Hospital of Wisconsin Department of Pediatric Urology
- UZ Antwerpen
- Ghent University Hospital
- UZ Leuven
- McMaster University Medical Centre
- CHU Sainte Justine
- Fakultni nemocnice Hradec Kralove
- Fakultni nemocnice Olomouc
- Hopital Pellegrin - Enfants
- CHU de Limoges - Hôpital Mère et l'Enfant
- Hôpital Necker Enfants-Malades
- Seconda Università di Napoli
- Bambin Gesù- Ospedale Pediatrico
- Copernicus Podmiot Leczniczy Sp. z o. o. Kliniczny Oddział Chirurgii i Urologii Dzieci i Młodzieży GUMed
- Specjalistyczny Gabinet Lekarski
- Medical University of Wroclaw
- University of Ankara
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
OnabotulinumtoxinA 50 U
OnabotulinumtoxinA 100 U
OnabotulinumtoxinA 200 U
Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).