NCT05003999

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

The Burden of Intermittent Catheterization in Adult Individuals With Neurogenic Lower Urinary Tract Dysfunction Following Spinal Cord Injury - Part 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Andrei Krassioukov · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-06-10
• Completion: 2019-06-28
• First posted: 2021-08-13
• Last updated: 2021-08-13

Locations

1 site across 1 country: Canada