Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

Heart Rate Variability During Urinary Bladder Catheterization in Individuals With Spinal Cord Injury: Anxiety Versus Sensory Discomfort

This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Anxiety State; Urinary Bladder, Neurogenic; Catheter Complications; Autonomic Dysreflexia
• Intervention / Treatment: 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

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 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Blusson Spinal Cord Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individuals with motor-complete SCI; Individuals with motor sensory complete injury (AIS A/B)	Procedure: Self-catheterization; Participants will perform self-catheterization, following the same routine for intermittent catheterization at home; Procedure: Catheterization performed by urology nurse, participant blinded to time of procedure; 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.; Procedure: Catheterization performed by urology nurse, participant aware of time of procedure; 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.
Experimental: Individuals with motor-incomplete SCI; Individuals with motor sensory incomplete injury (AIS C/D)	Procedure: Self-catheterization; Participants will perform self-catheterization, following the same routine for intermittent catheterization at home; Procedure: Catheterization performed by urology nurse, participant blinded to time of procedure; 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.; Procedure: Catheterization performed by urology nurse, participant aware of time of procedure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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	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	During catheterization performed by urology nurse, participant aware of time of procedure

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: ConvaTec Inc.; Vancouver Coastal Health; International Collaboration on Repair Discoveries
• Investigators: Principal Investigator: Andrei Krassioukov, MD,PhD,FRCPC, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): April 16, 2026
• Study Completion (Actual): April 16, 2026

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Intermittent Catheterization
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Trauma, Nervous System; Urinary Bladder Diseases; Spinal Cord Diseases; Autonomic Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Autonomic Dysreflexia; Investigative Techniques; Therapeutics; Catheterization; Urinary Catheterization; Intermittent Urethral Catheterization
• Other Study ID Numbers: H22-00971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No