Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

NCT05380661 | Completed

• 1 other identifier: H22-00971
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Anxiety State; Catheter Complications; Autonomic Dysreflexia

Keywords

Intermittent Catheterization

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (7)

• Baseline trait anxiety

  During screening

• Change in state anxiety in the context of self-catheterization (GA-VAS)

  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)

  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)

  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

  During self-catheterization

Study Arms (2)

Individuals with motor-complete SCI

EXPERIMENTAL

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-incomplete SCI

EXPERIMENTAL

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

Interventions

Self-catheterization PROCEDURE

Participants will perform self-catheterization, following the same routine for intermittent catheterization at home

Individuals with motor-complete SCI; Individuals with motor-incomplete SCI

Catheterization performed by urology nurse, participant blinded to time of procedure 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.

Individuals with motor-complete SCI; Individuals with motor-incomplete SCI

Catheterization performed by urology nurse, participant aware of time of procedure 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.

Individuals with motor-complete SCI; Individuals with motor-incomplete SCI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• ConvaTec Inc.: collaborator
• Vancouver Coastal Health: collaborator
• International Collaboration on Repair Discoveries: collaborator

Study Sites (1)

Blusson Spinal Cord Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Anxiety Disorders; Autonomic Dysreflexia

Interventions

Intermittent Urethral Catheterization

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Urinary Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Andrei Krassioukov, MD,PhD,FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants blinded to order of catheterization procedures conducted by the urology nurse.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 19, 2022
• Study Start: July 15, 2022
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CA (1)