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

NCT ID: NCT05003999

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-06-28

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.

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.

Conditions

Spinal Cord Injuries; Neurogenic Lower Urinary Tract Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

HPC - SpeediCath ®

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Non-HPC - Self-Cath ®

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Intermittent catheterization using a hydrophilic catheter (HPC); Intermittent catheterization using a non-hydrophilic catheter (non-HPC)

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

International Collaboration on Repair Discoveries

OTHER

Sponsor Role: collaborator

Vancouver Coastal Health

OTHER_GOV

Sponsor Role: collaborator

Coloplast A/S

INDUSTRY

Sponsor Role: collaborator

Andrei Krassioukov

OTHER

Sponsor Role: lead

Responsible Party

Andrei Krassioukov

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrei Krassioukov, MD, PhD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

Related Links

http://icord.org

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

Other Identifiers

COLO-AK-NLUTD-SCI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H17-03228 - Part 2

Identifier Type: -

Identifier Source: org_study_id