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

Neurogenic Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716624
• Other study ID #: R-11-140
• Secondary ID: 17787
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2011
• Last updated: October 25, 2012
• Start date: May 2011
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

Drug:
• Oxybutynin
standard oral therapy
• Botulinum Toxin A injection
10 units/kg injected into the detrusor muscle using cystoscopy

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Primary outcomes will be assessed at 3 and 6 months	No
Secondary	Calculate accrual rate		Secondary outcomes will be assessed at 6 months	No
Secondary	Calculate cross over rate		Secondary outcomes will be assessed at 6 months	No
Secondary	Calculate adverse event rates		Secondary outcomes will be assessed at 6 months	No
Secondary	Compare the side effects of standard oral therapy compared to Botulinum toxin A injection		Secondary outcomes will be assessed at 6 months	No
Secondary	Calculate drop out rate		Secondary outcomes will be assessed at 6 months	No