Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

University of British Columbia

Status: Enrolling

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

Treatments: Procedure: Catheterization performed by urology nurse, participant aware of time of procedure; Procedure: Catheterization performed by urology nurse, participant blinded to time of procedure; Procedure: Self-catheterization

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05380661

H22-00971

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Individuals with motor-complete SCI

Experimental group

Description:

Individuals with motor sensory complete injury (AIS A/B)

Treatment:

Procedure: Catheterization performed by urology nurse, participant aware of time of procedure

Procedure: Self-catheterization

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

Individuals with motor-incomplete SCI

Experimental group

Description:

Individuals with motor sensory incomplete injury (AIS C/D)

Treatment:

Procedure: Catheterization performed by urology nurse, participant aware of time of procedure

Procedure: Self-catheterization

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