Clinical trial NCT02097121: OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)
Official title: BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urinary Incontinence
Urinary Bladder
Overactive
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 56
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
timeFrame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Secondary outcomes:
measure: Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes
timeFrame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
measure: Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes
timeFrame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
measure: Percentage of Participants With Night Time Urinary Incontinence
timeFrame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
measure: Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)
timeFrame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
measure: Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)
timeFrame: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
measure: Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"
timeFrame: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
measure: Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"
timeFrame: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
measure: Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"
timeFrame: From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
measure: Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale
timeFrame: At Week 12 in Treatment Cycle 1
measure: Time to Participant's First Request for Retreatment
timeFrame: From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatment
measure: Time to Participant's Qualification for Retreatment
timeFrame: From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment
Other outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: From the first dose of study drug until the last dose, up to 147 weeks
Locations:
city: Anchorage
country: United States
facility: Alaska Urological Institute /ID# 238189
state: Alaska
city: Little Rock
country: United States
facility: Arkansas Children's Hospital /ID# 237787
state: Arkansas
city: Aurora
country: United States
facility: Children's Hospital Colorado /ID# 237621
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital - Yale School of Medicine /ID# 238222
state: Connecticut
city: Orlando
country: United States
facility: Orlando Health-Arnold Palmer Hospital for Children Pediatric Urology /ID# 235283
state: Florida
city: Raleigh
country: United States
facility: Associated Urologist of North Carolina /ID# 235437
state: North Carolina
city: Fort Worth
country: United States
facility: Cook Children's Med. Center /ID# 237539
state: Texas
city: Milwaukee
country: United States
facility: Children's Hospital Wisconsin - Milwaukee Campus /ID# 237544
state: Wisconsin
city: Randwick
country: Australia
facility: Sydney Children's Hospital /ID# 237191
state: New South Wales
city: Sydney
country: Australia
facility: The Children's Hospital at Westmead /ID# 234337
state: New South Wales
city: Clayton
country: Australia
facility: Monash Children's Hospital /ID# 234388
state: Victoria
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen /ID# 237997
state: Antwerpen
city: Gent
country: Belgium
facility: UZ Gent /ID# 237588
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 237218
state: Vlaams-Brabant
city: Calgary
country: Canada
facility: Alberta Children's Hospital /ID# 237510
state: Alberta
city: London
country: Canada
facility: London Health Sciences Center /ID# 234304
state: Ontario
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont /ID# 237668
state: Quebec
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc /ID# 237577
city: Bordeaux
country: France
facility: Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 237392
city: Limoges
country: France
facility: Hôpital de la Mère et de l'Enfant /ID# 235227
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-LENVAL /ID# 235278
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld /ID# 235234
city: Emmendingen
country: Germany
facility: Urologische Gemeinschaftspraxis /ID# 234978
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 234288
city: Napoli
country: Italy
facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 237308
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum /ID# 237043
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 237678
city: Oslo
country: Norway
facility: Oslo University Hospital /ID# 234434
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 238166
state: Dolnoslaskie
city: Poznan
country: Poland
facility: Specjalistyczny Gabinet Lekarski /ID# 235257
city: Warszawa
country: Poland
facility: Medical Concierge Centrum Medyczne /ID# 235200
city: Port Elizabeth
country: South Africa
facility: St Georges Hospital /ID# 235316
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust /ID# 234380
state: Lancashire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 234819
state: Norfolk
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 237430
state: Scotland
city: Aberdeen
country: United Kingdom
facility: NHS Grampian /ID# 237379
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust /ID# 237279
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust /ID# 236915
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust /ID# 237854
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: