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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

About this trial

This is an interventional prevention trial for Neurogenic Bladder focused on measuring Pediatric

Eligibility Criteria

5 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

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

Time Frame

Primary outcomes will be assessed at 3 and 6 months

Secondary Outcome Measure Information:

Title

Calculate accrual rate

Time Frame