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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02097121
Ethics application status
Date submitted
24/03/2014
Date registered
26/03/2014
Date last updated
28/12/2022

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 0 0
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
Treatment: Other - BOTOX®

Experimental: Botox 25 U - Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Experimental: Botox 50 U - Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Experimental: Botox 100 U - Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.


Treatment: Other: BOTOX®
Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Timepoint [1] 0 0
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Secondary outcome [1] 0 0
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes
Timepoint [1] 0 0
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Secondary outcome [2] 0 0
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes
Timepoint [2] 0 0
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Secondary outcome [3] 0 0
Percentage of Participants With Night Time Urinary Incontinence
Timepoint [3] 0 0
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Secondary outcome [4] 0 0
Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)
Timepoint [4] 0 0
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Secondary outcome [5] 0 0
Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)
Timepoint [5] 0 0
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Secondary outcome [6] 0 0
Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"
Timepoint [6] 0 0
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Secondary outcome [7] 0 0
Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"
Timepoint [7] 0 0
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Secondary outcome [8] 0 0
Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"
Timepoint [8] 0 0
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Secondary outcome [9] 0 0
Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale
Timepoint [9] 0 0
At Week 12 in Treatment Cycle 1
Secondary outcome [10] 0 0
Time to Participant's First Request for Retreatment
Timepoint [10] 0 0
From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatment
Secondary outcome [11] 0 0
Time to Participant's Qualification for Retreatment
Timepoint [11] 0 0
From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment

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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/02/2022
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Children's Hospital /ID# 237191 - Randwick
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead /ID# 234337 - Sydney
Recruitment hospital [3] 0 0
Monash Children's Hospital /ID# 234388 - Clayton
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Belgium
State/province [10] 0 0
Oost-Vlaanderen
Country [11] 0 0
Belgium
State/province [11] 0 0
Vlaams-Brabant
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Czechia
State/province [15] 0 0
Olomouc
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux
Country [17] 0 0
France
State/province [17] 0 0
Limoges
Country [18] 0 0
France
State/province [18] 0 0
Nice
Country [19] 0 0
Germany
State/province [19] 0 0
Bielefeld
Country [20] 0 0
Germany
State/province [20] 0 0
Emmendingen
Country [21] 0 0
Germany
State/province [21] 0 0
Luebeck
Country [22] 0 0
Italy
State/province [22] 0 0
Napoli
Country [23] 0 0
Netherlands
State/province [23] 0 0
Gelderland
Country [24] 0 0
Netherlands
State/province [24] 0 0
Maastricht
Country [25] 0 0
Norway
State/province [25] 0 0
Oslo
Country [26] 0 0
Poland
State/province [26] 0 0
Dolnoslaskie
Country [27] 0 0
Poland
State/province [27] 0 0
Poznan
Country [28] 0 0
Poland
State/province [28] 0 0
Warszawa
Country [29] 0 0
South Africa
State/province [29] 0 0
Port Elizabeth
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Lancashire
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Norfolk
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Scotland
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Aberdeen
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Liverpool
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Reading
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.
Trial website
https://clinicaltrials.gov/study/NCT02097121
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ALLERGAN INC.
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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