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

NCT ID: NCT01716624

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neurogenic Bladder

Keywords

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Pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oxybutynin

Group Type ACTIVE_COMPARATOR

Oxybutynin

Intervention Type DRUG

standard oral therapy

Botulinum Toxin A injection

Group Type EXPERIMENTAL

Botulinum Toxin A injection

Intervention Type DRUG

10 units/kg injected into the detrusor muscle using cystoscopy

Interventions

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Oxybutynin

standard oral therapy

Intervention Type DRUG

Botulinum Toxin A injection

10 units/kg injected into the detrusor muscle using cystoscopy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Sumit Dave

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sumit Dave, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre, Laweson Health Research Institute

Locations

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London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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17787

Identifier Type: OTHER

Identifier Source: secondary_id

R-11-140

Identifier Type: -

Identifier Source: org_study_id