Catheterization Methods for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Overseen byAndrei Krassioukov, MD,PhD,FRCPC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).
Eligibility Criteria
Adults aged 18-70 with chronic traumatic spinal cord injury, able to perform self-catheterization and complete questionnaires in English. Participants must be at least one year post-injury and six months from any spinal surgery. Excluded are those on the research team, with urinary tract issues or infections, history of bladder surgeries, taking heart rate affecting meds, pregnant women, or anyone with severe acute medical conditions.Inclusion Criteria
Any chronic traumatic SCI with either motor sensory complete injury (AIS A/B, N=10) or motor sensory incomplete injury (AIS B/D, N=10)
Must provide informed consent and be able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator)
At least 1 year post injury, and at least 6 months from any spinal surgery
+3 more
Exclusion Criteria
A member of the investigational team or his/her immediate family
You have had a past injury to your ureter (the tube that carries urine from the kidney to the bladder).
You currently have a urinary tract infection or other inflammation in your bladder or urethra.
+4 more
Participant Groups
The study compares how different catheterization methods affect anxiety and heart rate variability in individuals after a spinal cord injury. It tests self-catheterization versus nurse-performed procedures both when patients know and don't know the timing of the procedure.
2Treatment groups
Experimental Treatment
Group I: Individuals with motor-incomplete SCIExperimental Treatment3 Interventions
Individuals with motor sensory incomplete injury (AIS C/D)
Group II: Individuals with motor-complete SCIExperimental Treatment3 Interventions
Individuals with motor sensory complete injury (AIS A/B)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Blusson Spinal Cord CentreVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
International Collaboration on Repair DiscoveriesCollaborator
ConvaTec Inc.Industry Sponsor
Vancouver Coastal HealthCollaborator
International Collaboration on Repair DiscoveriesCollaborator