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

Sponsor
Andrei Krassioukov (Other)
Overall Status
Completed
CT.gov ID
NCT05003999
Collaborator
University of British Columbia (Other), International Collaboration On Repair Discoveries (ICORD) (Other), Vancouver Coastal Health (Other), Coloplast A/S (Industry)
20
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HPC - SpeediCath ®
  • Device: Non-HPC - Self-Cath ®
 N/A

Detailed Description

NLUTD and its management is of high priority for individuals living with SCI as it significantly reduces quality of life and interferes with their daily life. Intermittent catheterization in individuals with NLUTD following SCI is considered the preferred method of bladder emptying, i.e. gold standard.

Although intermittent catheterization offers reduced risk for urinary tract infection (UTI) compared to other methods of bladder emptying, the burden of complications including UTI and their management remains high. Another important aspect for individuals following SCI is improving quality of life. Since bladder management is a time-consuming and demanding task, reducing the time needed for intermittent catheterization and improving comfort during this procedure, i.e. convenience and ease of handling could significantly benefit quality of life for individuals living with SCI. Therefore, the investigators intend to compare hydrophilic versus non-hydrophilic catheters; time needed to perform intermittent catheterization and the convenience/ease of handling in this present study.

This is a prospective, randomized controlled crossover trial investigating the burden of intermittent catheterization in adult individuals with NLUTD following SCI.

Brief outline of study:

Visit 1 - Screening assessment to determine study eligibility. After providing informed consent, individuals will be assigned a unique study number and the following information will be collected:

  • Inclusion / exclusion criteria

  • Medical history including concomitant medication and procedures

  • Demographic information

The following procedures will be conducted:

  • Classification of SCI, i.e. neurological level and completeness using American Spinal Injury Association Impairment Scale (AIS)

  • Participants will be randomized, i.e. either to start with the hydrophilic and non-hydrophilic catheter second or vice versa.

Visit 2 - Participants will perform intermittent catheterization to obtain a urine sample for culture (women will be administered a pregnancy test).

Visit 3 - Assessment of time to perform intermittent catheterization using catheter A or B (depending on randomization, e.g., starting with catheter A) followed by feedback on convenience and ease of handling using a satisfaction survey.

Visit 4 - Assessment of time to perform intermittent catheterization using catheter A or B (depending on randomization, e.g., now using catheter B) followed by feedback on convenience and ease of handling using a satisfaction survey.

Visit 5 - Individuals will receive a phone call and be asked to provide information regarding any changes in health and specifically bladder health.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Two-by-two cross-over assignmentTwo-by-two cross-over assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Burden of Intermittent Catheterization in Adult Individuals With Neurogenic Lower Urinary Tract Dysfunction Following Spinal Cord Injury - Part 2
Actual Study Start Date :
Dec 1, 2018
Actual Primary Completion Date :
Jun 10, 2019
Actual Study Completion Date :
Jun 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intermittent catheterization starting with a hydrophilic catheter (HPC)

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 ®
The investigators measure the time taken to perform intermittent catheterization using a 13 step pre-determined intermittent catheterization protocol using a hydrophilic catheter
Other Names:
  • Intermittent catheterization using a hydrophilic catheter (HPC)

    		•
    Active Comparator: Intermittent catheterization starting with a non-hydrophilic catheter (non-HPC)

    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 ®
    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
    Other Names:
  • Intermittent catheterization using a non-hydrophilic catheter (non-HPC)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Differences in time needed to perform intermittent catheterization between two types of catheters [Through study completion, an average of two weeks]

      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).

    2. Difference in convenience to perform intermittent catheterization between two types of catheters [Through study completion, an average of two weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female or male

    • 18 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

    Exclusion Criteria:

    • In addition to not fulfilling the inclusion criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of British Columbia Vancouver British Columbia Canada V5Z 1M9

    Sponsors and Collaborators

    • Andrei Krassioukov
    • University of British Columbia
    • International Collaboration On Repair Discoveries (ICORD)
    • Vancouver Coastal Health
    • Coloplast A/S

    Investigators

    • Principal Investigator: Andrei Krassioukov, MD, PhD, FRCPC, University of British Columbia

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Andrei Krassioukov, Principal Investigator, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT05003999
    Other Study ID Numbers:
    • H17-03228 - Part 2
    • COLO-AK-NLUTD-SCI
    First Posted:
    Aug 13, 2021
    Last Update Posted:
    Aug 13, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Andrei Krassioukov, Principal Investigator, University of British Columbia
    Spinal Cord Injury
    Intermittent Catheterization
    Hydrophilic Catheter
    Non-Hydrophilic Catheter
    Quality of Life
    Time
    Preparation
    Satisfaction
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Wounds and Injuries

    Study Results

    No Results Posted as of Aug 13, 2021