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Catheterization Methods for Spinal Cord Injury

N/A
Recruiting
Led By Andrei Krassioukov, MD,PhD,FRCPC
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during screening
Awards & highlights

Summary

This trial looks at the effects of intermittent catheterization on physical and mental health in people with spinal cord injuries.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
There may not be direct side effects from the interventions as they involve standard catheterization procedures; however, participants might experience discomfort or anxiety during the process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during self-catheterization
This trial's timeline: 3 weeks for screening, Varies for treatment, and during self-catheterization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BP during catheterization performed by urology nurse, participant aware of time of procedure
BP during catheterization performed by urology nurse, participant blinded to time of procedure
Blood pressure (BP) during self-catheterization
+6 more
Secondary study objectives
Baseline trait anxiety
Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant aware of time of procedure
Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant blinded to time of procedure
+4 more

Trial Design

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 Location

Who is running the clinical trial?

International Collaboration on Repair DiscoveriesUNKNOWN
7 Previous Clinical Trials
205 Total Patients Enrolled
3 Trials studying Autonomic Dysreflexia
116 Patients Enrolled for Autonomic Dysreflexia
University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,483,170 Total Patients Enrolled
4 Trials studying Autonomic Dysreflexia
103 Patients Enrolled for Autonomic Dysreflexia
ConvaTec Inc.Industry Sponsor
47 Previous Clinical Trials
4,911 Total Patients Enrolled
~1 spots leftby Dec 2024
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