NCT01716624

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
Last Updated

October 30, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

June 29, 2011

Last Update Submit

October 25, 2012

Conditions

Neurogenic Bladder

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

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

    The following urodynamic parameters will be measured; 1. Change in end fill pressure or detrusor leak point pressure (cm H2O) 2. Change in 20 and 30 cm H2O below volumes expressed as percentage of bladder capacity 3. Change in reflex volume (percentage of bladder capacity at which neurogenic detrusor overactivity starts)

    Primary outcomes will be assessed at 3 and 6 months

Secondary Outcomes (5)

  • Calculate accrual rate

    Secondary outcomes will be assessed at 6 months

  • Calculate cross over rate

    Secondary outcomes will be assessed at 6 months

  • Calculate adverse event rates

    Secondary outcomes will be assessed at 6 months

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

    Secondary outcomes will be assessed at 6 months

  • Calculate drop out rate

    Secondary outcomes will be assessed at 6 months

Study Arms (2)

Oxybutynin

ACTIVE COMPARATOR
Drug: Oxybutynin

Botulinum Toxin A injection

EXPERIMENTAL
Drug: Botulinum Toxin A injection

Interventions

OxybutyninDRUG

standard oral therapy

Oxybutynin
Botulinum Toxin A injectionDRUG

10 units/kg injected into the detrusor muscle using cystoscopy

Botulinum Toxin A injection

Eligibility Criteria

Age5 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

oxybutyninBotulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Sumit Dave, MD

    London Health Sciences Centre, Laweson Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2011

First Posted

October 30, 2012

Study Start

May 1, 2011

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

CA(1)