Status:
RECRUITING
Heart Rate Variability and Anxiety During Urinary Bladder Catheterization
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
ConvaTec Inc.
Vancouver Coastal Health
Conditions:
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).
Detailed Description
Given that intermittent catheterization is the recommended method of bladder management in individuals with SCI, it is crucial that the potentially negative cardiovascular and psychological responses ...
Eligibility Criteria
Inclusion
- Male or female, 18-70 years of age
- 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).
- At least 1 year post injury, and at least 6 months from any spinal surgery
- Hand function sufficient to perform intermittent catheterization for management of urinary bladder drainage
- 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)
- Willing and able to comply with clinic visit and study-related procedures
Exclusion
- Signs or known current urinary tract infection, or other inflammatory conditions of bladder/urethra
- Currently taking beta blockers or other medications that may affect heart rate
- History of ureteral injury
- History of any urinary diversion procedures, including but not limited to bladder augmentation, cystectomy, neo bladder, pouch reservoir, ileal conduit, Mitrofanoff appendicovesicostomy
- For women of childbearing potential, currently pregnant
- A member of the investigational team or his/her immediate family Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05380661
Start Date
July 15 2022
End Date
December 1 2024
Last Update
April 26 2024
Active Locations (1)
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1
Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada, V5Z 1M9