Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients

November 13, 2019 updated by: Allergan

BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2650
        • UZ Antwerpen
      • Gent, Belgium, 9000
        • UZ Gent , Urology
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine
  • Czechia
      • Hradec Králové, Czechia, 50005
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 77520
        • Fakultni nemocnice Olomouc
  • France
      • Bordeaux, France, 33076
        • Hopital Pellegrin - Enfants
      • Limoges, France, 87000
        • CHU de Limoges - Hopital Mere et l'Enfant
      • Paris, France, 75015
        • Necker Enfants malades hospital
      • Paris, France, 75012
        • Hopital Trousseau
  • Italy
      • Caserta, Italy, 80138
        • Seconda Universita di Napoli
      • Roma, Italy, 00165
        • IRCCS Ospedale Pediatrico Bambino Gesù
  • Poland
      • Gdansk, Poland, 80-803
        • Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed
      • Poznan, Poland, 61-512
        • Specjalistyczny Gabinet Lekarski
      • Wroclaw, Poland, 50-369
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • Turkey
      • Ankara, Turkey, 6100
        • Ankara University Medical Faculty Cebeci Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46032
        • Riley Hospital for Children
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital Research Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Tarrytown, New York, United States, 10591
        • Pediatric Urology Associates, PC
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • McKay Urology Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Health System
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Childrens Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Urinary incontinence due to neurogenic detrusor overactivity
  • Regularly using clean intermittent catheterization to empty the bladder

Exclusion Criteria:

  • Surgery of the spinal cord within 6 months
  • Diagnosis of cerebral palsy
  • 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 within 3 months for any other condition or use
  • Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OnabotulinumtoxinA 50 U
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
EXPERIMENTAL: OnabotulinumtoxinA 100 U
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
EXPERIMENTAL: OnabotulinumtoxinA 200 U
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1.
Other Names:
  • BOTOX®
  • botulinum toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
Time Frame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.
Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Time Frame: First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of treatment.
First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
Change From Baseline in Average Urine Volume at First Morning Catheterization
Time Frame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. A positive change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Percentage of Participants With Night Time Urinary Incontinence
Time Frame: Baseline (Day -28 to Day -1), Week 6
Urinary incontinence was defined as involuntary loss of urine and the presence or absence of night time urinary incontinence was recorded by the participant in a bladder diary in the 2 consecutive days (normalized to a 12-hour daytime period) during the week prior to the study visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories (0, 1, 2 nights).
Baseline (Day -28 to Day -1), Week 6
Change From Baseline in Maximum Cystometric Capacity (MCC)
Time Frame: Baseline (Day -28 to Day -1) to Week 6
The MCC was defined by urodynamics, as the volume infused before the participant felt they could no longer delay micturition (has a strong desire to void), had a leakage, or 500 mL was instilled. A positive change from Baseline indicates improvement (increase) in the maximum volume of urine the bladder holds. Least squares estimates were based on an ANCOVA model.
Baseline (Day -28 to Day -1) to Week 6
Percentage of Participants With Involuntary Detrusor Contractions (IDC)
Time Frame: Baseline (Day -28 to -1) and Week 6
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the presence of involuntary detrusor contractions upon filling. A reduction in IDCs from Baseline to Week 6 indicates improvement.
Baseline (Day -28 to -1) and Week 6
Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC
Time Frame: Baseline (Day-28 to Day-1) to Week 6
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Baseline (Day-28 to Day-1) to Week 6
Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase
Time Frame: Baseline (Day 1) to Week 6
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Baseline (Day 1) to Week 6
Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase
Time Frame: Baseline (Day -28 to -1) to Week 6
DLPP was defined as the lowest detrusor pressure at which urine leakage occurs in the absence of either a detrusor contraction or increased intra-abdominal pressure. Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates are based on an ANCOVA model.
Baseline (Day -28 to -1) to Week 6
Time to Participant Request for Retreatment
Time Frame: 48 weeks
Time from treatment on Day 1 to request for retreatment was estimated. For those participants who did not request retreatment, their data was censored using the date of their last study visit.
48 weeks
Time to Participant Qualification for Retreatment
Time Frame: 48 weeks
In order to qualify for retreatment, the criteria listed below must be fulfilled at the qualification for retreatment visit: Participant/parent/caregiver requests retreatment, participant has a total of at least 2 daytime urinary incontinence episodes over the 2-day bladder diary collection period, at least 12 weeks has elapsed since treatment 1 and participant has not experienced a serious treatment-related adverse event at any time.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Margarita Furmanov, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 2, 2013

Primary Completion (ACTUAL)

October 11, 2018

Study Completion (ACTUAL)

October 11, 2018

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (ESTIMATE)

May 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-120
  • 2012-004877-26 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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