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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02097121




Registration number
NCT02097121
Ethics application status
Date submitted
24/03/2014
Date registered
26/03/2014
Date last updated
21/05/2020

Titles & IDs
Public title
OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)
Scientific title
BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
Secondary ID [1] 0 0
2014-000464-17
Secondary ID [2] 0 0
191622-137
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Incontinence 0 0
Urinary Bladder, Overactive 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - OnabotulinumtoxinA

Experimental: OnabotulinumtoxinA Dose A - OnabotulinumtoxinA Dose A injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.

Experimental: OnabotulinumtoxinA Dose B - OnabotulinumtoxinA Dose B injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.

Experimental: OnabotulinumtoxinA Dose C - OnabotulinumtoxinA Dose C injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.


Other interventions: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Number of Daytime Urinary Incontinence Episodes
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Change from Baseline in Number of Daytime Micturition Episodes
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Volume Voided Per Micturition
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change from Baseline in Number of Daytime Urgency Episodes
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Percentage of Patients with Night Time Urinary Incontinence
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Patients with Absence of Night Time Urinary Incontinence
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Change from Baseline in the 20-Item Pediatric Incontinence Questionnaire (PinQ) Score
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Percentage of Patients With a Positive Treatment Response on the Modified Treatment Benefit Scale (TBS)
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Time to Patient Request for Retreatment
Timepoint [8] 0 0
96 Weeks
Secondary outcome [9] 0 0
Time to Patient Qualification for Retreatment
Timepoint [9] 0 0
96 Weeks

Eligibility
Key inclusion criteria
- Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for
at least 6 months

- OAB symptoms not adequately managed by 1 or more anticholinergic agents
Minimum age
12 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- OAB caused by a neurological condition

- Use of anticholinergics or other medications to treat OAB symptoms within 7 days

- Current use of indwelling catheter or 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Monash Children's Hospital - Clayton
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2031 - Westmead
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
Belgium
State/province [11] 0 0
Edegem
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Czechia
State/province [16] 0 0
Olomouc
Country [17] 0 0
France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
France
State/province [18] 0 0
Limoges
Country [19] 0 0
France
State/province [19] 0 0
Nice
Country [20] 0 0
Germany
State/province [20] 0 0
Bielefeld
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Germany
State/province [21] 0 0
Emmendingen
Country [22] 0 0
Germany
State/province [22] 0 0
Lübeck
Country [23] 0 0
Italy
State/province [23] 0 0
Napoli
Country [24] 0 0
Italy
State/province [24] 0 0
Rome
Country [25] 0 0
Netherlands
State/province [25] 0 0
Maastricht
Country [26] 0 0
Netherlands
State/province [26] 0 0
Nijmegen
Country [27] 0 0
Netherlands
State/province [27] 0 0
Rotterdam
Country [28] 0 0
Norway
State/province [28] 0 0
Oslo
Country [29] 0 0
Poland
State/province [29] 0 0
Lublin
Country [30] 0 0
Poland
State/province [30] 0 0
Poznan
Country [31] 0 0
Poland
State/province [31] 0 0
Warsaw
Country [32] 0 0
South Africa
State/province [32] 0 0
Port Elizabeth
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Aberdeen
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Liverpool
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United Kingdom
State/province [35] 0 0
London
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United Kingdom
State/province [36] 0 0
Manchester
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United Kingdom
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Norwich
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United Kingdom
State/province [38] 0 0
Reading
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United Kingdom
State/province [39] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) for the
treatment of urinary incontinence due to overactive bladder in pediatric patients between the
ages of 12 to 17 years who have not been adequately managed with anticholinergics.
Trial website
https://clinicaltrials.gov/show/NCT02097121
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brenda Jenkins
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Registry Team
Address 0 0
Country 0 0
Phone 0 0
1-877-277-8566
Fax 0 0
Email 0 0
IR-CTRegistration@Allergan.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02097121