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Intermittent catheterization starting with a hydrophilic catheter (HPC) for Spinal Cord Injury

N/A
Waitlist Available
Led By Andrei Krassioukov, MD, PhD, FRCPC
Research Sponsored by Andrei Krassioukov
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of two weeks
Awards & highlights

Summary

This study investigates the burden of intermittent catheterization in adult individuals with neurogenic lower urinary tract dysfunction (NLUTD) following spinal cord injury (SCI). Individuals will be recruited to compare two types of catheters. Each participant will use a non-hydrophilic catheter at one time point and a hydrophilic catheter at a different time point to perform intermittent catheterization. The order that participants use either a non-hydrophilic or a hydrophilic catheter will be determined randomly. The purpose of the study is to provide evidence for time spent on bladder management (performing intermittent catheterization) as well as consumer satisfaction on using both catheters.

Eligible Conditions
  • Neurogenic Bladder Dysfunction
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of two weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in convenience to perform intermittent catheterization between two types of catheters
Differences in time needed to perform intermittent catheterization between two types of catheters

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intermittent catheterization starting with a hydrophilic catheter (HPC)Experimental Treatment1 Intervention
The investigators measure the time taken to perform intermittent catheterization using a 13 step pre-determined intermittent catheterization protocol using a hydrophilic catheter i.e. SpeediCath ® (Coloplast A/S, Humlebæk, Denmark)
Group II: Intermittent catheterization starting with a non-hydrophilic catheter (non-HPC)Active Control1 Intervention
The investigators measure the time taken to perform intermittent catheterization using a 13 step pre-determined intermittent catheterization protocol using a non-hydrophilic catheter i.e. Self-Cath ® (Coloplast A/S, Humlebæk, Denmark); Lubrication jelly (MUKO ®, 3.5g package, Cardinal Health Canada Inc, Toronto, ON, Canada) was provided
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HPC - SpeediCath ®
2018
N/A
~20

Find a Location

Who is running the clinical trial?

International Collaboration on Repair DiscoveriesOTHER
7 Previous Clinical Trials
205 Total Patients Enrolled
Vancouver Coastal HealthOTHER_GOV
39 Previous Clinical Trials
717,150 Total Patients Enrolled
University of British ColumbiaOTHER
1,451 Previous Clinical Trials
2,483,170 Total Patients Enrolled
~3 spots leftby Sep 2025