Catheterization performed by urology nurse, participant aware of time of procedure for Urinary Bladder, Neurogenic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Blusson Spinal Cord Centre, Vancouver, Canada
Urinary Bladder, Neurogenic+5 More
Catheterization performed by urology nurse, participant aware of time of procedure - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions

  • Urinary Bladder, Neurogenic
  • Anxiety
  • Complications; Catheter
  • Autonomic Dysreflexia
  • Spinal Cord Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Urinary Bladder, Neurogenic

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure

5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (STAIS-5)
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 blinded to time of procedure (GA-VAS)
Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (STAIS-5)
5 minutes before and 5 minutes after self-catheterization
Change in state anxiety in the context of self-catheterization (GA-VAS)
Change in state anxiety in the context of self-catheterization (STAIS-5)
5 minutes before and 5 minutes aftercatheterization performed by urology nurse, participant aware of time of procedure
Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (GA-VAS)
During catheterization performed by urology nurse, participant aware of time of procedure
BP 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
During catheterization performed by urology nurse, participant blinded to time of procedure
BP 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
During screening
Baseline trait anxiety
During self-catheterization
BP during self-catheterization
HR during self-catheterization

Trial Safety

Safety Progress

1 of 3

Other trials for Urinary Bladder, Neurogenic

Trial Design

2 Treatment Groups

Individuals with motor-complete SCI
1 of 2
Individuals with motor-incomplete SCI
1 of 2
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Catheterization performed by urology nurse, participant aware of time of procedure · No Placebo Group · N/A

Individuals with motor-complete SCIExperimental Group · 3 Interventions: Self-catheterization, Catheterization performed by urology nurse, participant blinded to time of procedure, Catheterization performed by urology nurse, participant aware of time of procedure · Intervention Types: Procedure, Procedure, Procedure
Individuals with motor-incomplete SCIExperimental Group · 3 Interventions: Self-catheterization, Catheterization performed by urology nurse, participant blinded to time of procedure, Catheterization performed by urology nurse, participant aware of time of procedure · Intervention Types: Procedure, Procedure, Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
Closest Location: Blusson Spinal Cord Centre · Vancouver, Canada
Photo of Vancouver 1Photo of Vancouver 2Photo of Vancouver 3
2012First Recorded Clinical Trial
3 TrialsResearching Urinary Bladder, Neurogenic
3 CompletedClinical Trials

Who is running the clinical trial?

International Collaboration on Repair DiscoveriesUNKNOWN
3 Previous Clinical Trials
114 Total Patients Enrolled
1 Trials studying Urinary Bladder, Neurogenic
40 Patients Enrolled for Urinary Bladder, Neurogenic
Vancouver Coastal HealthOTHER_GOV
36 Previous Clinical Trials
11,988 Total Patients Enrolled
ConvaTec Inc.Industry Sponsor
37 Previous Clinical Trials
4,453 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,295 Previous Clinical Trials
1,270,987 Total Patients Enrolled
2 Trials studying Urinary Bladder, Neurogenic
52 Patients Enrolled for Urinary Bladder, Neurogenic
Andrei Krassioukov, MD,PhD,FRCPCPrincipal InvestigatorUniversity of British Columbia
4 Previous Clinical Trials
68 Total Patients Enrolled
2 Trials studying Urinary Bladder, Neurogenic
52 Patients Enrolled for Urinary Bladder, Neurogenic

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had a spinal surgery within the past year.
Hand function sufficient to perform intermittent catheterization for management of urinary bladder drainage.
You must be able to understand and complete study-related questionnaires.
You are willing and able to comply with the clinic visit and study-related procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.