Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
2 other identifiers
interventional
114
8 countries
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2013
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2013
CompletedFirst Posted
Study publicly available on registry
May 13, 2013
CompletedStudy Start
First participant enrolled
July 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2018
CompletedResults Posted
Study results publicly available
October 30, 2019
CompletedNovember 21, 2019
November 1, 2019
5.3 years
May 9, 2013
October 11, 2019
November 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.
Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Secondary Outcomes (10)
Number of Participants With Treatment Emergent Adverse Events (TEAE)
First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
Change From Baseline in Average Urine Volume at First Morning Catheterization
Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Percentage of Participants With Night Time Urinary Incontinence
Baseline (Day -28 to Day -1), Week 6
Change From Baseline in Maximum Cystometric Capacity (MCC)
Baseline (Day -28 to Day -1) to Week 6
Percentage of Participants With Involuntary Detrusor Contractions (IDC)
Baseline (Day -28 to -1) and Week 6
- +5 more secondary outcomes
Study Arms (3)
OnabotulinumtoxinA 50 U
EXPERIMENTALOnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified.
OnabotulinumtoxinA 100 U
EXPERIMENTALOnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
OnabotulinumtoxinA 200 U
EXPERIMENTALOnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
Interventions
OnabotulinumtoxinA injected into the detrusor wall on Day 1.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (31)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46032, United States
William Beaumont Hospital Research Institute
Royal Oak, Michigan, 48073, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Pediatric Urology Associates, PC
Tarrytown, New York, 10591, United States
McKay Urology Carolinas Medical Center
Charlotte, North Carolina, 28207, United States
Duke University Health System
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Oklahoma Childrens Hospital
Oklahoma City, Oklahoma, 73104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
UZ Antwerpen
Antwerp, 2650, Belgium
UZ Gent , Urology
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
Fakultni nemocnice Olomouc
Olomouc, 77520, Czechia
Hopital Pellegrin - Enfants
Bordeaux, 33076, France
CHU de Limoges - Hopital Mere et l'Enfant
Limoges, 87000, France
Hopital Trousseau
Paris, 75012, France
Necker Enfants Malades Hospital
Paris, 75015, France
Seconda Università di Napoli
Caserta, 80138, Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, 00165, Italy
Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed
Gdansk, 80-803, Poland
Specjalistyczny Gabinet Lekarski
Poznan, 61-512, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, 50-369, Poland
Ankara University Medical Faculty Cebeci Hospital
Ankara, 6100, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Margarita Furmanov
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2013
First Posted
May 13, 2013
Study Start
July 2, 2013
Primary Completion
October 11, 2018
Study Completion
October 11, 2018
Last Updated
November 21, 2019
Results First Posted
October 30, 2019
Record last verified: 2019-11