Investigating heart rate and anxiety during bladder catheterization in spinal cord injury patients
Heart Rate Variability During Urinary Bladder Catheterization in Individuals With Spinal Cord Injury: Anxiety Versus Sensory Discomfort
This study tests how catheterization affects heart rate and anxiety in adults with spinal cord injuries to better understand their experiences during the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05380661 on ClinicalTrials.gov |
What this trial studies
This study examines the physical and psychological experiences of intermittent catheterization in adults with spinal cord injuries. Participants will perform self-catheterization and undergo two standard catheterization procedures by a urology nurse, with continuous cardiovascular monitoring throughout. The study aims to assess anxiety levels before and after each procedure to understand the impact of catheterization on cardiovascular and psychological responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with chronic traumatic spinal cord injuries who can perform intermittent catheterization.
Not a fit: Patients with current urinary tract infections or those on medications affecting heart rate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of bladder care in spinal cord injury patients by addressing anxiety and cardiovascular responses during catheterization.
How similar studies have performed: Other studies have explored similar interventions in catheterization, but this specific focus on heart rate variability and anxiety during the procedure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Vancouver, British Columbia
- Blusson Spinal Cord Centre — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Andrei Krassioukov, MD,PhD,FRCPC — University of British Columbia
- Study coordinator: Andrea Maharaj, BSc
- Email: amaharaj@icord.org
- Phone: (604) 675-8856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.