Clinical trial NCT05380661: Heart Rate Variability and Anxiety During Urinary Bladder Catheterization
Official title: Heart Rate Variability During Urinary Bladder Catheterization in Individuals With Spinal Cord Injury: Anxiety Versus Sensory Discomfort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Urinary Bladder, Neurogenic
Anxiety State
Catheter Complications
Autonomic Dysreflexia
Keywords: Intermittent Catheterization
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: ConvaTec Inc.
name: Vancouver Coastal Health
name: International Collaboration on Repair Discoveries
First posted: 2022-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure (BP) during self-catheterization
timeFrame: During self-catheterization
measure: Heart rate (HR) during self-catheterization
timeFrame: During self-catheterization
measure: BP during catheterization performed by urology nurse, participant blinded to time of procedure
timeFrame: During catheterization performed by urology nurse, participant blinded to time of procedure
measure: HR during catheterization performed by urology nurse, participant blinded to time of procedure
timeFrame: During catheterization performed by urology nurse, participant blinded to time of procedure
measure: BP during catheterization performed by urology nurse, participant aware of time of procedure
timeFrame: During catheterization performed by urology nurse, participant aware of time of procedure
measure: HR during catheterization performed by urology nurse, participant aware of time of procedure
timeFrame: During catheterization performed by urology nurse, participant aware of time of procedure
measure: Change in state anxiety in the context of self-catheterization (STAIS-5)
timeFrame: 5 minutes before and 5 minutes after self-catheterization
measure: Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (STAIS-5)
timeFrame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure
measure: Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (STAIS-5)
timeFrame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
Secondary outcomes:
measure: Baseline trait anxiety
timeFrame: During screening
measure: Change in state anxiety in the context of self-catheterization (GA-VAS)
timeFrame: 5 minutes before and 5 minutes after self-catheterization
measure: Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (GA-VAS)
timeFrame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure
measure: Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (GA-VAS)
timeFrame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
measure: Change in heart rate variability (HRV) during self-catheterization
timeFrame: During self-catheterization
measure: Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant blinded to time of procedure
timeFrame: During catheterization performed by urology nurse, participant blinded to time of procedure
measure: Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant aware of time of procedure
timeFrame: During catheterization performed by urology nurse, participant aware of time of procedure
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Blusson Spinal Cord Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Andrei Krassioukov, MD,PhD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: