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

Lawson Health Research Institute

Status and phase

Completed

Phase 3

Conditions

Neurogenic Bladder

Treatments

Drug: Oxybutynin

Drug: Botulinum Toxin A injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01716624

17787 (Other Identifier)

R-11-140

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

5 to 20 years old

Volunteers

No 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