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

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ClinicalTrials.gov Identifier: NCT02298660
Recruitment Status : Unknown
Verified November 2014 by Rick Hansen Institute.
Recruitment status was:  Recruiting
First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Rick Hansen Institute

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 neurogenic bladder detrusor hyperreflexia will decrease the severity of AD in individuals with SCI one month following treatment.


Condition or disease Intervention/treatment Phase
Autonomic Dysreflexia Drug: BOTOX Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Botox Treatment for Neurogenic Detrusor Overactivity on the Prevention of Autonomic Dysreflexia Following Spinal Cord Injury
Study Start Date : April 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BOTOX
BOTOX® Total dose OR units/kg (per patient): 200U Number of cycles:1 cycle Treatments will be conducted according to established protocol, 200 units with intravesical injections under cystoscopic guided injections into 20 points. One month later, urodynamics with continuous arterial blood pressure and electrocardiogram measurements will be repeated, as well as 24 hour blood pressure monitoring. AD- HR QoL and I-QoL questionnaires will be administered to evaluate the effect of Botox on AD-QoL and bladder-related QoL.
Drug: BOTOX

BOTOX® Total dose OR units/kg (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.

Other Name: Botulinum toxin Type A, BTX-A,




Primary Outcome Measures :
  1. 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 ]

    To assess the effect of intradetrusor injected Botox on reducing AD (maximum systolic blood pressure substracted average 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.



Secondary Outcome Measures :
  1. 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.

  2. 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?

  3. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 to individuals with following levels of injury:
  • 40 subjects with supra-sacral injury with stable neurologic condition (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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298660


Contacts
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Contact: Renee J. Fougere, MSc., RN, 604-379-8014 reneefougere@gmail.com
Contact: Andrei V. Krassioukov, M.D, PhD, 604-675-8819 andrei.krassioukov@vch.ca

Locations
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Canada, British Columbia
International Collaboration on Repair Discoveries (ICORD) and Blusson Recruiting
Vancouver, British Columbia, Canada, v5z 1m9
Contact    604-379-8014    reneefougere@gmail.com   
Contact    604-675-8819    andrei.krassioukov@vch.ca   
Principal Investigator: Andrei V. Krassioukov, MD, PhD,         
Sponsors and Collaborators
Rick Hansen Institute
Investigators
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Principal Investigator: Andrei V. Krassioukov, M.D, PhD ICORD-Blusson, UBC, G.F. Strong Rehabilitation Centre

Additional Information:
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Responsible Party: Rick Hansen Institute
ClinicalTrials.gov Identifier: NCT02298660     History of Changes
Other Study ID Numbers: Rick Hansen Institute
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: November 2014
Keywords provided by Rick Hansen Institute:
Autonomic Dysreflexia
Spinal Cord Injury
OnabotulinumtoxinA
Neurogenic detrusor overactivity
Urodynamics
Cardiovascular
Quality of life
Blood pressure
Twenty-four hour ambulatory blood pressure monitoring
Additional relevant MeSH terms:
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Spinal Cord Injuries
Autonomic Dysreflexia
Nervous System Diseases
Trauma, Nervous System
Autonomic Nervous System Diseases
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents