Spinal Cord InjuriesNCT05380661
Heart Rate Variability and Anxiety During Urinary Bladder Catheterization
A study testing Self-catheterization, Catheterization performed by urology nurse, participant blinded to time of procedure and Catheterization performed by urology nurse, participant aware of time of procedure in people with Spinal Cord Injuries and Urinary Bladder, Neurogenic, run by University of British Columbia at 1 site in Canada.
Trial summary
This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Urinary Bladder, Neurogenic, Anxiety State
- What is being tested?
- Self-catheterization, Catheterization performed by urology nurse, participant blinded to time of procedure and Catheterization performed by urology nurse, participant aware of time of procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2022to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Spinal Cord Injuries, Urinary Bladder, Neurogenic, Anxiety State, Catheter Complications, Autonomic Dysreflexia
- Being tested
- Self-catheterization, Catheterization performed by urology nurse, participant blinded to time of procedure, Catheterization performed by urology nurse, participant aware of time of procedure
- Keywords
- Intermittent Catheterization
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic, Anxiety Disorders, Autonomic Dysreflexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-catheterizationProcedure or surgery
Participants will perform self-catheterization, following the same routine for intermittent catheterization at home
Catheterization performed by urology nurse, participant blinded to time of procedureProcedure or surgery
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 procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with motor-complete SCI | Experimental | Individuals with motor sensory complete injury (AIS A/B) Receives: 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: During catheterization performed by urology nurse, participant aware of time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start15 Jul 2022
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- ConvaTec Inc., Vancouver Coastal Health, International Collaboration on Repair Discoveries
- Responsible party
- Principal investigator, Andrei Krassioukov, University of British Columbia
- Investigators
- Andrei Krassioukov, MD,PhD,FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380661
- Sponsor's protocol ID
- H22-00971
- Status last verified
- Apr 2026
- First submitted
- 5 May 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability During Urinary Bladder Catheterization in Individuals With Spinal Cord Injury: Anxiety Versus Sensory Discomfort
- ClinicalTrials.gov ID
- NCT05380661
- Acronym / sponsor ID
- H22-00971
- Conditions
- Spinal Cord Injuries, Urinary Bladder, Neurogenic, Anxiety State, Catheter Complications, Autonomic Dysreflexia
- Keywords
- Intermittent Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- ConvaTec Inc., Vancouver Coastal Health, International Collaboration on Repair Discoveries
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with motor-complete SCI | Experimental | 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 procedureIndividuals with motor sensory complete injury (AIS A/B) |
| Individuals with motor-incomplete SCI | Experimental | 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 procedureIndividuals with motor sensory incomplete injury (AIS C/D) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-catheterizationParticipants will perform self-catheterization, following the same routine for intermittent catheterization at home | Procedure or surgery | Individuals with motor-complete SCI, Individuals with motor-incomplete SCI |
| Catheterization performed by urology nurse, participant blinded to time of procedureParticipant 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 or surgery | Individuals with motor-complete SCI, Individuals with motor-incomplete SCI |
| Catheterization performed by urology nurse, participant aware of time of procedureParticipant 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. | Procedure or surgery | Individuals with motor-complete SCI, Individuals with motor-incomplete SCI |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
7 secondary outcomes
Baseline trait anxiety
Time frame: During screening
Change in state anxiety in the context of self-catheterization (GA-VAS)
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)
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)
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
Time frame: During self-catheterization
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Krassioukov, MD,PhD,FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-catheterization, Catheterization performed by urology nurse, participant blinded to time of procedure and Catheterization performed by urology nurse, participant aware of time of procedure in people with Spinal Cord Injuries and Urinary Bladder, Neurogenic, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (BP) during self-catheterization (time frame: During self-catheterization). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.