Status:
COMPLETED
Botox for Neurogenic Detrusor Overactivity and the Prevention of Autonomic Dysreflexia Following SCI
Lead Sponsor:
Rick Hansen Institute
Collaborating Sponsors:
University of British Columbia
International Collaboration on Repair Discoveries
Conditions:
Autonomic Dysreflexia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Detailed Description
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 us...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2017
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT02298660
Start Date
April 1 2013
End Date
December 15 2017
Last Update
December 26 2019
Active Locations (1)
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1
International Collaboration on Repair Discoveries (ICORD)
Vancouver, British Columbia, Canada, V5Z 1M9