Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01716624

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder	Drug: Oxybutynin Drug: Botulinum Toxin A injection	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

May 1, 2011

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oxybutynin	Drug: Oxybutynin standard oral therapy
Experimental: Botulinum Toxin A injection	Drug: Botulinum Toxin A injection 10 units/kg injected into the detrusor muscle using cystoscopy

Arm

Intervention/Treatment

Active Comparator: Oxybutynin

Drug: Oxybutynin

standard oral therapy

Experimental: Botulinum Toxin A injection

Drug: Botulinum Toxin A injection

10 units/kg injected into the detrusor muscle using cystoscopy

Outcome Measures

Primary Outcome Measures

To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy [Primary outcomes will be assessed at 3 and 6 months]
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 [Secondary outcomes will be assessed at 6 months]
Calculate cross over rate [Secondary outcomes will be assessed at 6 months]
Calculate adverse event rates [Secondary outcomes will be assessed at 6 months]
Compare the side effects of standard oral therapy compared to Botulinum toxin A injection [Secondary outcomes will be assessed at 6 months]
Calculate drop out rate [Secondary outcomes will be assessed at 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 20 Years

Sexes Eligible for Study:

All

Accepts 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