Neurogenic BladderPhase 3NCT01716624
Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
A Phase 3 study testing Oxybutynin and Botulinum Toxin A injection in people with Neurogenic Bladder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- Oxybutynin and Botulinum Toxin A injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
About this study
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
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.
- Conditions
- Neurogenic Bladder
- Being tested
- Oxybutynin, Botulinum Toxin A injection
- Keywords
- Pediatric
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
standard oral therapy
Botulinum Toxin A injectionDrug
10 units/kg injected into the detrusor muscle using cystoscopy
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin | Active comparator | Not described Receives: Drug: Oxybutynin |
| Botulinum Toxin A injection | Experimental | Not described Receives: Drug: Botulinum Toxin A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Primary outcomes will be assessed at 3 and 6 months
Secondary outcomes (5)
Calculate accrual rate
Measured: Secondary outcomes will be assessed at 6 months
Calculate cross over rate
Measured: Secondary outcomes will be assessed at 6 months
Calculate adverse event rates
Measured: Secondary outcomes will be assessed at 6 months
Compare the side effects of standard oral therapy compared to Botulinum toxin A injection
Measured: Secondary outcomes will be assessed at 6 months
Calculate drop out rate
Measured: Secondary outcomes will be assessed at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumit Dave, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Sumit Dave, MD, Principal investigator, London Health Sciences Centre, Laweson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716624
- Sponsor's protocol ID
- R-11-140
- Other IDs
- 17787
- Status last verified
- Oct 2012
- First submitted
- 29 Jun 2011
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01716624
- Acronym / sponsor ID
- R-11-140
- Conditions
- Neurogenic Bladder
- Keywords
- Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin | Active comparator | Drug: Oxybutynin |
| Botulinum Toxin A injection | Experimental | Drug: Botulinum Toxin A injection |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxybutyninstandard oral therapy | Drug | Oxybutynin |
| Botulinum Toxin A injection10 units/kg injected into the detrusor muscle using cystoscopy | Drug | Botulinum Toxin A injection |
Primary outcome
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; 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)
5 secondary outcomes
Calculate accrual rate
Time frame: Secondary outcomes will be assessed at 6 months
Calculate cross over rate
Time frame: Secondary outcomes will be assessed at 6 months
Calculate adverse event rates
Time frame: Secondary outcomes will be assessed at 6 months
Compare the side effects of standard oral therapy compared to Botulinum toxin A injection
Time frame: Secondary outcomes will be assessed at 6 months
Calculate drop out rate
Time frame: Secondary outcomes will be assessed at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumit Dave, MD principal investigator
London Health Sciences Centre, Laweson Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxybutynin and Botulinum Toxin A injection in people with Neurogenic Bladder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.