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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; Mandelic Acids; onabotulinumtoxinA; Oxybutynin

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