Botox for Neurogenic Detrusor Overactivity and the Prevention of Autonomic Dysreflexia Following SCI

• Status: Completed
• Trial end date: 2017-12-15
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Inpatients or outpatients with SCI (AIS A-D)

• Male and female

• Age between 18 - 65

• Chronic, traumatic SCI (> 1 year post injury)

• Affected by urinary incontinence

• We are expecting individuals with the following levels of injury:

• individuals with spinal segment thoracic (T) 6 and above (with history of episodes of AD) Presence of AD will be determined using a validated AD questionnaire.

• Good command and comprehension of English

• Capable of giving informed consent

Exclusion Criteria:

• Age older than 66 years

• Documented traumatic brain injury

• Acute co-morbidities

• Other diseases of the neural system

• Previous genitourinary disease or operation,

• Current urinary tract infection

• Multiple injury levels

• Previous history of systemic illness, such as cardiovascular diseases (as hypertension and cardiac infarction), cerebrovascular accident, diabetes, etc

• Poor command of English language

• Pregnancy