Heart Rate Variability and Anxiety During Urinary Bladder Catheterization
NCT ID: NCT05380661
Last Updated: 2024-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-07-15
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
SINGLE
Study Groups
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Individuals with motor-complete SCI
Individuals with motor sensory complete injury (AIS A/B)
Self-catheterization
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
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
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.
Individuals with motor-incomplete SCI
Individuals with motor sensory incomplete injury (AIS C/D)
Self-catheterization
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
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
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.
Interventions
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Self-catheterization
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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ConvaTec Inc.
INDUSTRY
Vancouver Coastal Health
OTHER_GOV
International Collaboration on Repair Discoveries
OTHER
University of British Columbia
OTHER
Responsible Party
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Andrei Krassioukov
Principal Investigator
Principal Investigators
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Andrei Krassioukov, MD,PhD,FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H22-00971
Identifier Type: -
Identifier Source: org_study_id
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