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Completed

NCT Number: NCT01716624

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

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.

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Key information

Conditions

Neurogenic Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxybutynin

Drug

standard oral therapy

Botulinum Toxin A Injection

Drug

10 units/kg injected into the detrusor muscle using cystoscopy

Primary outcomes

  1. To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy

    Time frame: 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 outcomes

  1. Calculate accrual rate

    Time frame: Secondary outcomes will be assessed at 6 months

  2. Calculate cross over rate

    Time frame: Secondary outcomes will be assessed at 6 months

  3. Calculate adverse event rates

    Time frame: Secondary outcomes will be assessed at 6 months

  4. Compare the side effects of standard oral therapy compared to Botulinum toxin A injection

    Time frame: Secondary outcomes will be assessed at 6 months

  5. Calculate drop out rate

    Time frame: Secondary outcomes will be assessed at 6 months

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 30, 2012
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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