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Trial record 1 of 2 for:    NCT01852045
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Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01852045
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : October 30, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
Actual Study Start Date : July 2, 2013
Actual Primary Completion Date : October 11, 2018
Actual Study Completion Date : October 11, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01852045


Locations
Show Show 31 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Margarita Furmanov Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Statistical Analysis Plan  [PDF] November 12, 2018
Study Protocol  [PDF] September 27, 2017

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01852045    
Other Study ID Numbers: 191622-120
2012-004877-26 ( EudraCT Number )
First Posted: May 13, 2013    Key Record Dates
Results First Posted: October 30, 2019
Last Update Posted: November 21, 2019
Last Verified: November 2019

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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
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
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