A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
NCT ID: NCT01852058
Last Updated: 2020-05-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
95 participants
INTERVENTIONAL
2014-01-11
2019-10-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
NCT01852045
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
NCT03320850
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
NCT01945489
An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder
NCT02161159
Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
NCT00915525
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OnabotulinumtoxinA 50 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).
OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
OnabotulinumtoxinA 100 U
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).
OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
OnabotulinumtoxinA 200 U
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).
OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
5 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brenda Jenkins
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Bambin Gesù- Ospedale Pediatrico
Rome, , Italy
Copernicus Podmiot Leczniczy Sp. z o. o. Kliniczny Oddział Chirurgii i Urologii Dzieci i Młodzieży GUMed
Gdansk, , Poland
Specjalistyczny Gabinet Lekarski
Poznan, , Poland
Medical University of Wroclaw
Wroclaw, , Poland
University of Ankara
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
More Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-004898-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
191622-121
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.