Clinical trial NCT01852058: A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Official title: Long-term Extension Study of 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: 95
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


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

Primary outcomes:
measure: Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
timeFrame: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
measure: Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2
timeFrame: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
measure: Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3
timeFrame: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)
timeFrame: First injection on Day 1 in Study 120 through completion of Study 121 (Up to 108 weeks)
measure: Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 1
timeFrame: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
measure: Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 2
timeFrame: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
measure: Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 3
timeFrame: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
measure: Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 1
timeFrame: Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
measure: Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 2
timeFrame: Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
measure: Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 3
timeFrame: Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
measure: Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1
timeFrame: Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
measure: Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2
timeFrame: Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
measure: Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3
timeFrame: Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
measure: Average Time to Participant's Request for Retreatment
timeFrame: First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)
measure: Average Time to Participant's Qualification for Retreatment
timeFrame: First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)
measure: Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 1
timeFrame: Week 6 in Treatment Cycle 1
measure: Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 2
timeFrame: Week 6 in Treatment Cycle 2
measure: Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 3
timeFrame: Week 6 in Treatment Cycle 3
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Division of Urology Research Office
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: St. Louis Children's Hospital Division of Urology
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
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center Cincinnati Center for Clinical Research and Outpatient Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Children's 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 Department of Pediatric Urology
state: Wisconsin
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: Ghent University Hospital
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 Kralove
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 - HÃ´pital MÃ¨re et l'Enfant
city: Paris
country: France
facility: Hôpital Necker Enfants-Malades
city: Naples
country: Italy
facility: Seconda Università di Napoli
city: Rome
country: Italy
facility: Bambin Gesù- Ospedale Pediatrico
city: Gdansk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o. o. Kliniczny Oddział Chirurgii i Urologii Dzieci i Młodzieży GUMed
city: Poznań
country: Poland
facility: Specjalistyczny Gabinet Lekarski
city: Wroclaw
country: Poland
facility: Medical University of Wroclaw
city: Ankara
country: Turkey
facility: University of Ankara
Study officials:
affiliation: Allergan
name: Brenda Jenkins
role: STUDY_DIRECTOR
References: