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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effect of Botox Treatment for Neurogenic Detrusor Overactivity on the Prevention of Autonomic Dysreflexia Following Spinal Cord Injury

Brief 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 neur

Detailed Summary:

Purpose: This study is a Phase IV pilot study. A phase IV study is a study of an approved drug or treatment conducted to obtain information regarding the drug's or treatment's, benefits and optimal use. The investigators will assess the efficacy of Botox on reducing autonomic dysreflexia during regular treatment for neurogenic detrusor overactivity in those with spinal cord injury. The aim of the study is not to prove the positive/negative effects of Botox injections on urinary bladder function (this has been previously been established in randomized controlled clinical trials), but to gain information if this intervention could ameliorate changes in arterial blood pressure (namely prevent autonomic dysreflexia) that commonly occurs due to neurogenic detrusor overactivity. This study will particularly determine whether established Botox therapy for neurogenic detrusor overactivity could decrease the severity of episodes of AD by at least 50%.

Objective 1: The primary objective of this study is to assess the efficacy of intradetrusor injected Botox on amelioration of episodes of AD in individuals with chronic SCI.

Primary outcome:

To assess the effect of Botox on reducing AD as per the average systolic blood pressure change (maximum systolic blood pressure subtracted the average supine baseline systolic blood pressure) induced by urodynamics.

The end point of the trial will be a decrease of severity of AD in 50% of participants. By definition AD is considered an episode of hypertension due to painful or non painful stimuli below the level of injury with an increase in systolic blood pressure by at least 20-40 mmHg, from previously measured, individual baselines.

Episodes of AD
Sponsor: Rick Hansen Institute

Current Primary Outcome: Assess the efficacy of 200 U intradetrusor injected Botox on amelioration of episodes of autonomic dysreflexia (AD) in individuals with chronic spinal cord injury one month following treatment during urodynamics [ Time Frame: One month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• The blocking of AD during 24 hour ambulatory blood pressure monitoring with daily catherizations. [ Time Frame: One month ]
  To assess the effect of the intravesical administration of BOTOX on blocking of AD responses and severity of AD (maximum variability in systolic blood pressure during 24 hour ambulatory blood pressure monitoring) with daily catheterizations.
• Cost analysis of BOTOX treatment on AD following six months of treatment. [ Time Frame: One year ]
  To undertake a cost analysis of BOTOX treatment on AD care following six months of treatment. What are the economic implications of BOTOX treatments for bladder management of individuals with SCI on health care for individuals with respect to management of AD episodes and hospital admissions?
• The impact of BOTOX and blocking of AD response on enhanced quality of life (QOL) and incontinence health related QOL. [ Time Frame: One month ]
  To assess the effect of the intravesical administration of BOTOX and blocking of AD responses on health-related quality of life (HRQoL) and incontinence health-related quality of life (IQOL).

Original Secondary Outcome: Same as current

Information By: Rick Hansen Institute

Dates:
Date Received: September 17, 2012
Date Started: April 2013
Date Completion: January 2015
Last Updated: November 19, 2014
Last Verified: November 2014