An interventional study of Self-catheterization and Catheterization performed by urology nurse, participant blinded to time of procedure in Spinal Cord Injuries, Urinary Bladder, Neurogenic and Anxiety State, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University of British Columbia · Not applicable, Interventional, and Supportive care
This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).
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 to this procedure are examined. Individuals will undergo self-catheterization, then two standard of care catheterization procedures performed by an experienced urology nurse, while either blinded to or aware of time of catheterization. Continuous cardiovascular monitoring will be in place throughout all three procedures. Assessment of anxiety will be administered pre- and post- each procedure.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 22 is close to the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Individuals with motor sensory complete injury (AIS A/B)
Procedure: Self-catheterization · Procedure: Catheterization performed by urology nurse, participant blinded to time of procedure · Procedure: Catheterization performed by urology nurse, participant aware of time of procedure
Individuals with motor sensory incomplete injury (AIS C/D)
Procedure: Self-catheterization · Procedure: Catheterization performed by urology nurse, participant blinded to time of procedure · Procedure: Catheterization performed by urology nurse, participant aware of time of procedure
Participants will perform self-catheterization, following the same routine for intermittent catheterization at home
Participant will undergo procedure to completely empty bladder; Participant in supine position, and resting blood pressure and heart rate will be recorded for period of 5 minutes prior to catheterization; Perineum and genital areas will be draped and they will be not aware about exact timing of catheterization Catheterization will be conducted following standard clinic procedure by experience urology nurse.
Participant will undergo procedure to completely empty bladder; Participant in supine position, and resting BP and HR will be recorded for period of 5 minutes prior to catheterization; Perineum and genital areas will be visible to participant and they will be fully aware about exact timing of catheterization Catheterization will be conducted following standard clinic procedure by experience urology nurse.
Blood pressure (BP) during self-catheterization
Systolic and diastolic BP (mmHg) will be measured continuously (beat-by-beat) via finger photoplethysmography, corrected to brachial pressure. BP will be measured 5 minutes prior to and then throughout the self-catheterization procedure.
Time frame: During self-catheterization
Heart rate (HR) during self-catheterization
HR (BPM) will be recorded continuously via one-lead electrocardiogram. HR will be measured 5 minutes prior to and then throughout the self-catheterization procedure.
Time frame: During self-catheterization
BP during catheterization performed by urology nurse, participant blinded to time of procedure
Systolic and diastolic BP (mmHg) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is blinded to time of procedure.
Time frame: During catheterization performed by urology nurse, participant blinded to time of procedure
HR during catheterization performed by urology nurse, participant blinded to time of procedure
HR (BPM) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is blinded to time of procedure.
Time frame: During catheterization performed by urology nurse, participant blinded to time of procedure
BP during catheterization performed by urology nurse, participant aware of time of procedure
Systolic and diastolic BP (mmHg) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is aware of time of procedure.
Time frame: During catheterization performed by urology nurse, participant aware of time of procedure
HR during catheterization performed by urology nurse, participant aware of time of procedure
HR (BPM) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is aware of time of procedure.
Time frame: During catheterization performed by urology nurse, participant aware of time of procedure
Change in state anxiety in the context of self-catheterization (STAIS-5)
The State-Trait Anxiety Inventory - State, 5 item version (STAIS-5) will be used to measure participants' state anxiety prior to and after self-catheterization. Sum score of the STAIS-5 will be calculated, which ranges between 5 to 20, with higher score indicating greater state anxiety.
Time frame: 5 minutes before and 5 minutes after self-catheterization
Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (STAIS-5)
The STAIS-5 will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is blinded to time of procedure. Sum score of the STAIS-5 will be calculated, which ranges between 5 to 20, with higher score indicating greater state anxiety.
Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure
Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (STAIS-5)
The STAIS-5 will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is aware of time of procedure. Sum score of the STAIS-5 will be calculated, which ranges between 5 to 20, with higher score indicating greater state anxiety.
Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
Baseline trait anxiety
The 7-item General Anxiety Disorder (GAD) scale will be used to measure participants' anxiety. The GAD-7 sum score will be calculated, ranging from 0 to 21, with higher score indicating more severe anxiety symptoms.
Time frame: During screening
Change in state anxiety in the context of self-catheterization (GA-VAS)
The Global Anxiety-Visual Analogue Scale (GA-VAS) will be used to measure participants' state anxiety prior to and after self-catheterization. Rating can range between 0 to 10, with higher rating on the GA-VAS indicates greater state anxiety.
Time frame: 5 minutes before and 5 minutes after self-catheterization
Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (GA-VAS)
The GA-VAS will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is blinded to time of procedure. Rating can range between 0 to 10, higher rating on the GA-VAS indicates greater state anxiety.
Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure
Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (GA-VAS)
The GA-VAS will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is aware of time of procedure. Higher rating on the GA-VAS indicates greater state anxiety.
Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
Change in heart rate variability (HRV) during self-catheterization
HRV will be calculated from continuous ECG recording
Time frame: During self-catheterization
Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant blinded to time of procedure
HRV will be calculated from continuous ECG recording
Time frame: During catheterization performed by urology nurse, participant blinded to time of procedure
Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant aware of time of procedure
HRV will be calculated from continuous ECG recording
Time frame: During catheterization performed by urology nurse, participant aware of time of procedure
Plan to share: Undecided
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University of British Columbia