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| Name | Class |
|---|---|
| ConvaTec Inc. | INDUSTRY |
| Vancouver Coastal Health | OTHER_GOV |
| International Collaboration on Repair Discoveries | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with motor-complete SCI | Experimental | Individuals with motor sensory complete injury (AIS A/B) |
|
| Individuals with motor-incomplete SCI | Experimental | Individuals with motor sensory incomplete injury (AIS C/D) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-catheterization | Procedure | Participants will perform self-catheterization, following the same routine for intermittent catheterization at home |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Krassioukov, MD,PhD,FRCPC | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blusson Spinal Cord Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
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Participants blinded to order of catheterization procedures conducted by the urology nurse.
| 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. |
|
| 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 |
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 |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D001750 | Urinary Bladder, Neurogenic |
| D001008 | Anxiety Disorders |
| D020211 | Autonomic Dysreflexia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001342 | Autonomic Nervous System Diseases |
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| ID | Term |
|---|---|
| D057928 | Intermittent Urethral Catheterization |
| ID | Term |
|---|---|
| D014546 | Urinary Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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