Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
Primary Purpose
Neurogenic Bladder
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Oxybutynin
Botulinum Toxin A injection
Sponsored by
About this trial
This is an interventional prevention trial for Neurogenic Bladder focused on measuring Pediatric
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of spina bifida and neurogenic bladder
- Performing clean intermittent catheterization (CIC)
- Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder
- Has not had previous bladder surgery
- Has had a urodynamic or videourodynamic study done within the last 6 months
- Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study
- Urodynamic study (UDS) showing either detrusor leak point pressure >40cm H2O; 30cm below capacity <60% of total bladder capacity, 20 cm capacity <70% of bladder capacity
- Able and willing to complete CIC Diaries and Quality of Life Questionnaires
- Consent and assent given to participate in trial
Exclusion Criteria:
- History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia
- Positive urine culture
- Known allergy to Botox
Sites / Locations
- London Health Sciences Centre - Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Oxybutynin
Botulinum Toxin A injection
Arm Description
Outcomes
Primary Outcome Measures
To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy
The following urodynamic parameters will be measured;
Change in end fill pressure or detrusor leak point pressure (cm H2O)
Change in 20 and 30 cm H2O below volumes expressed as percentage of bladder capacity
Change in reflex volume (percentage of bladder capacity at which neurogenic detrusor overactivity starts)
Secondary Outcome Measures
Calculate accrual rate
Calculate cross over rate
Calculate adverse event rates
Compare the side effects of standard oral therapy compared to Botulinum toxin A injection
Calculate drop out rate
Full Information
NCT ID
NCT01716624
First Posted
June 29, 2011
Last Updated
October 25, 2012
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01716624
Brief Title
Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
Official Title
A Pilot Study Comparing the Effects of Botulinum Toxin A and Standard Oxybutynin Therapy as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy for children with neurogenic bladder due to spina bifida and compare results with standard oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain or improve bladder storage function without side effects associated with oxybutynin use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder
Keywords
Pediatric
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxybutynin
Arm Type
Active Comparator
Arm Title
Botulinum Toxin A injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Intervention Description
standard oral therapy
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin A injection
Intervention Description
10 units/kg injected into the detrusor muscle using cystoscopy
Primary Outcome Measure Information:
Title
To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy
Description
The following urodynamic parameters will be measured;
Change in end fill pressure or detrusor leak point pressure (cm H2O)
Change in 20 and 30 cm H2O below volumes expressed as percentage of bladder capacity
Change in reflex volume (percentage of bladder capacity at which neurogenic detrusor overactivity starts)
Time Frame
Primary outcomes will be assessed at 3 and 6 months
Secondary Outcome Measure Information:
Title
Calculate accrual rate
Time Frame
Secondary outcomes will be assessed at 6 months
Title
Calculate cross over rate
Time Frame
Secondary outcomes will be assessed at 6 months
Title
Calculate adverse event rates
Time Frame
Secondary outcomes will be assessed at 6 months
Title
Compare the side effects of standard oral therapy compared to Botulinum toxin A injection
Time Frame
Secondary outcomes will be assessed at 6 months
Title
Calculate drop out rate
Time Frame
Secondary outcomes will be assessed at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of spina bifida and neurogenic bladder
Performing clean intermittent catheterization (CIC)
Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder
Has not had previous bladder surgery
Has had a urodynamic or videourodynamic study done within the last 6 months
Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study
Urodynamic study (UDS) showing either detrusor leak point pressure >40cm H2O; 30cm below capacity <60% of total bladder capacity, 20 cm capacity <70% of bladder capacity
Able and willing to complete CIC Diaries and Quality of Life Questionnaires
Consent and assent given to participate in trial
Exclusion Criteria:
History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia
Positive urine culture
Known allergy to Botox
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumit Dave, MD
Organizational Affiliation
London Health Sciences Centre, Laweson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
12. IPD Sharing Statement
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Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
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