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

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.

Conditions

• Autonomic Dysreflexia

Interventions

DRUG

BOTOX

BOTOX® Total dose per patient: 200U Number of cycles:1 cycle 200 units of BOTOX® will be injected per procedure. BOTOX® will be diluted in 15mL saline to 20U/mL. BOTOX® injections will be performed with a normal 22 FF rigid cystoscopy or flexible 6Fr injection needle. BOTOX® will be injected into the detrusor muscle at 20 sites (10U per site), sparing the trigone. A local anaesthesia with instillation of 50 ml lidocaine 2% into the bladder will be done prior to the procedure to avoid autonomic dysreflexia.

Sponsors & Collaborators

• University of British Columbia

  collaborator OTHER

• International Collaboration on Repair Discoveries

  collaborator OTHER

• Vancouver Coastal Health

  collaborator OTHER_GOV

• Rick Hansen Institute

  lead OTHER

Principal Investigators

• Andrei V. Krassioukov, M.D, PhD · ICORD-Blusson, UBC, G.F. Strong Rehabilitation Centre

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2017-10-17

Completion

2017-12-15

Countries

• Canada

Study Locations