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Time Needed to Perform Intermittent Catheterization in Adults With Spinal Cord Injuries

NCT05003999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-13

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries
  • Neurogenic Lower Urinary Tract Dysfunction

Interventions

DEVICE

HPC - SpeediCath ®

The investigators measure the time taken to perform intermittent catheterization using a 13 step pre-determined intermittent catheterization protocol using a hydrophilic catheter

DEVICE

Non-HPC - Self-Cath ®

The investigators measure the time taken to perform intermittent catheterization using a 13 step pre-determined intermittent catheterization protocol using a non-hydrophilic catheter; Lubrication jelly (MUKO ®, 3.5g package, Cardinal Health Canada Inc, Toronto, ON, Canada) was provided

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • International Collaboration on Repair Discoveries

    collaborator OTHER

  • Vancouver Coastal Health

    collaborator OTHER_GOV

  • Coloplast A/S

    collaborator INDUSTRY

  • Andrei Krassioukov

    lead OTHER

Principal Investigators

  • Andrei Krassioukov, MD, PhD, FRCPC · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-06-10
Completion
2019-06-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003999 on ClinicalTrials.gov