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

NCT05003999 | Completed

• 2 other identifiers: H17-03228 - Part 2COLO-AK-NLUTD-SCI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Spinal Cord Injury; Intermittent Catheterization; Hydrophilic Catheter; Non-Hydrophilic Catheter; Quality of Life; Time; Preparation; Satisfaction

Outcome Measures

Primary Outcomes (2)

• Differences in time needed to perform intermittent catheterization between two types of catheters

  A measure of time (seconds) taken to perform intermittent catheterization using a 13 step pre-determined intermittent catheterization protocol where the first catheter will be different from the later catheter (i.e. hydrophilic vs. non-hydrophilic catheter).

  Through study completion, an average of two weeks

• Difference in convenience to perform intermittent catheterization between two types of catheters

  To assess the difference in convenience (ease of handling) for two catheters, i.e. using a hydrophilic vs. a non-hydrophilic catheter, as determined by using a survey.

  Through study completion, an average of two weeks

Study Arms (2)

Intermittent catheterization starting with a hydrophilic catheter (HPC)

EXPERIMENTAL

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)

Device: HPC - SpeediCath ®

Intermittent catheterization starting with a non-hydrophilic catheter (non-HPC)

ACTIVE COMPARATOR

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

Device: Non-HPC - Self-Cath ®

Interventions

HPC - SpeediCath ® DEVICE

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

Also known as: Intermittent catheterization using a hydrophilic catheter (HPC)

Intermittent catheterization starting with a hydrophilic catheter (HPC)

Non-HPC - Self-Cath ® DEVICE

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

Also known as: Intermittent catheterization using a non-hydrophilic catheter (non-HPC)

Intermittent catheterization starting with a non-hydrophilic catheter (non-HPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male
• years of age or older
• Presenting with a chronic SCI (i.e. greater than one year post-injury) at any level and with any severity (i.e. American Spinal Injury Association scale grade A to E )
• Hand function sufficient to perform intermittent catheterization for management of urinary bladder drainage
• Willing and able to comply with all clinic visits and study-related procedures
• Must provide informed consent and be able to understand and complete study-related instructions (must be able to understand and speak English)
• Women must not be pregnant
• Must not have any urinary diversion procedure, such as bladder augmentation, cystectomy, neo bladder, pouch reservoir, ileal conduit, Mitrofanoff appendicovesicostomy or similar

You may not qualify if:

• Presence of severe acute medical issue that in the investigator's judgement would adversely affect the individual's participation in the study
• Individuals who do not perform intermittent catheterization
• Individuals who are members of the investigational team and immediate family

Sponsors & Collaborators

• Andrei Krassioukov: lead
• University of British Columbia: collaborator
• International Collaboration on Repair Discoveries: collaborator
• Vancouver Coastal Health: collaborator
• Coloplast A/S: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Links

• ICORD is a spinal cord injury research centre of the UBC Faculty of Medicine and VCH Research Institute.

MeSH Terms

Conditions

Spinal Cord Injuries; Personal Satisfaction

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Andrei Krassioukov, MD, PhD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-by-two cross-over assignment

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: August 13, 2021
• Study Start: December 1, 2018
• Primary Completion: June 10, 2019
• Study Completion: June 28, 2019
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)