Botox for Neurogenic Detrusor Overactivity and the Prevention of Autonomic Dysreflexia Following SCI
Status:
Completed
Trial end date:
2017-12-15
Target enrollment:
Participant gender:
Summary
The purpose of this study is to investigate the impact of 200 U intradetrusor injected
OnabotulinumtoxinA (Botox®, Allergan, Inc.) (20 sites, trigone sparing) for neurogenic
detrusor overactivity (NDO) and its role on reducing autonomic dysreflexia (AD) in those with
chronic, traumatic spinal cord injury (SCI). In clinical practice, urinary bladder
dysfunctions are commonly associated with episodes of AD. If AD is misdiagnosed or poorly
managed, it may result in myocardial infarction, stroke, seizure, intracerebral hemorrhaging
or even death. Reducing AD would dramatically improve the health and well-being of Canadians
with SCI, and positively impact health care costs. There are an estimated 7,343 hospital
re-admissions due to SCI-related conditions in Canada every year, with an estimated 5-year
cost of $661 million. Reducing hospital re-admissions for secondary complications of SCI by
only 10% over this time period could result in a costs savings of $66 million for Canada.
Considering these statistics, the present study could be a first attempt to evaluate the
economic impact of using Botox® to manage the urinary bladder following SCI. We will be able
to examine its impact on episodes of AD and consequently calculate the cost saving for the
Canadian health system. A significant number of individuals with SCI will require frequent
emergency room visits due to episodes of uncontrolled AD that originate predominately from
the urinary bladder. There is clinical evidence demonstrating that costs of bladder
management following SCI will depend on the understanding of the volumes that the urinary
bladder can safely hold. This is one of the positive outcomes that have been established in
previous trials of Botox® therapy for the neurogenic bladder.
Hypothesis: 200 U of intradetrusor injected Botox® (20 sites, trigone sparing) for neurogenic
bladder detrusor hyperreflexia will decrease the severity of AD in individuals with SCI one
month following treatment.
Phase:
Phase 4
Details
Lead Sponsor:
Rick Hansen Institute
Collaborators:
International Collaboration On Repair Discoveries (ICORD) University of British Columbia Vancouver Coastal Health
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA