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OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02097121
Recruitment Status : Recruiting
First Posted : March 26, 2014
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Urinary Bladder, Overactive Biological: OnabotulinumtoxinA Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
Actual Study Start Date : May 23, 2014
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 29, 2023

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Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
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.
 Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
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.
 Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
Other Names:
  • BOTOX®
  • botulinum toxin Type A


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Number of Daytime Urinary Incontinence Episodes [ Time Frame: Baseline, Week 12 ]

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

Other Outcome Measures:
  1. Number of patients experiencing a treatment emergent adverse event (TEAE) [ Time Frame: Approximately 96 weeks ]
    The number of patients who experienced one or more TEAE during the 96 week treatment period


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097121


Contacts
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Contact: Clinical Trials Registry Team 1-877-277-8566 IR-CTRegistration@Allergan.com

Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Brenda Jenkins Allergan
More Information
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Additional Information:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02097121    
Other Study ID Numbers: 191622-137
2014-000464-17 ( EudraCT Number )
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
 Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents