Clinical trial NCT01852045: Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
Official title: BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-05-13
Enrollment: 114
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
timeFrame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE)
timeFrame: First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
measure: Change From Baseline in Average Urine Volume at First Morning Catheterization
timeFrame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
measure: Percentage of Participants With Night Time Urinary Incontinence
timeFrame: Baseline (Day -28 to Day -1), Week 6
measure: Change From Baseline in Maximum Cystometric Capacity (MCC)
timeFrame: Baseline (Day -28 to Day -1) to Week 6
measure: Percentage of Participants With Involuntary Detrusor Contractions (IDC)
timeFrame: Baseline (Day -28 to -1) and Week 6
measure: Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC
timeFrame: Baseline (Day-28 to Day-1) to Week 6
measure: Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase
timeFrame: Baseline (Day 1) to Week 6
measure: Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase
timeFrame: Baseline (Day -28 to -1) to Week 6
measure: Time to Participant Request for Retreatment
timeFrame: 48 weeks
measure: Time to Participant Qualification for Retreatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Royal Oak
country: United States
facility: William Beaumont Hospital Research Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Tarrytown
country: United States
facility: Pediatric Urology Associates, PC
state: New York
city: Charlotte
country: United States
facility: McKay Urology Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Childrens Hospital
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent , Urology
city: Leuven
country: Belgium
facility: UZ Leuven
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Bordeaux
country: France
facility: Hopital Pellegrin - Enfants
city: Limoges
country: France
facility: CHU de Limoges - Hopital Mere et l'Enfant
city: Paris
country: France
facility: Hopital Trousseau
city: Paris
country: France
facility: Necker Enfants Malades Hospital
city: Caserta
country: Italy
facility: Seconda Università di Napoli
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesu
city: Gdansk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed
city: Poznan
country: Poland
facility: Specjalistyczny Gabinet Lekarski
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Cebeci Hospital
Study officials:
affiliation: Allergan
name: Margarita Furmanov
role: STUDY_DIRECTOR
References: