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Completed

NCT Number: NCT05380661

Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blusson Spinal Cord Centre

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-catheterization

Procedure

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

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.

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.

Primary outcomes

  1. Blood pressure (BP) during self-catheterization

    Time frame: 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.

  2. Heart rate (HR) during self-catheterization

    Time frame: 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.

  3. BP during catheterization performed by urology nurse, participant blinded to time of procedure

    Time frame: 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.

  4. HR during catheterization performed by urology nurse, participant blinded to time of procedure

    Time frame: 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.

  5. BP during catheterization performed by urology nurse, participant aware of time of procedure

    Time frame: 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.

  6. HR during catheterization performed by urology nurse, participant aware of time of procedure

    Time frame: 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.

  7. Change in state anxiety in the context of self-catheterization (STAIS-5)

    Time frame: 5 minutes before and 5 minutes after self-catheterization

    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.

  8. Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (STAIS-5)

    Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure

    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.

  9. Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (STAIS-5)

    Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure

    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.

Secondary outcomes

  1. Baseline trait anxiety

    Time frame: During screening

    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.

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

    Time frame: 5 minutes before and 5 minutes after self-catheterization

    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.

  3. Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (GA-VAS)

    Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure

    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.

  4. Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (GA-VAS)

    Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure

    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. Change in heart rate variability (HRV) during self-catheterization

    Time frame: During self-catheterization

    HRV will be calculated from continuous ECG recording

  6. Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant blinded to time of procedure

    Time frame: During catheterization performed by urology nurse, participant blinded to time of procedure

    HRV will be calculated from continuous ECG recording

  7. Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant aware of time of procedure

    Time frame: During catheterization performed by urology nurse, participant aware of time of procedure

    HRV will be calculated from continuous ECG recording

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • ConvaTec Inc.
  • International Collaboration on Repair Discoveries
  • Vancouver Coastal Health

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 19, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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