Spinal Cord InjuriesNCT05003999
Time Needed to Perform Intermittent Catheterization in Adults With Spinal Cord Injuries
A study testing HPC - SpeediCath ® and Non-HPC - Self-Cath ® in people with Spinal Cord Injuries and Neurogenic Lower Urinary Tract Dysfunction, run by Andrei Krassioukov at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Lower Urinary Tract Dysfunction
- What is being tested?
- HPC - SpeediCath ® and Non-HPC - Self-Cath ®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2018to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: The Burden of Intermittent Catheterization in Adult Individuals With Neurogenic Lower Urinary Tract Dysfunction Following Spinal Cord Injury - Part 2
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.
Read the 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.
- Being tested
- HPC - SpeediCath ®, Non-HPC - Self-Cath ®
- Keywords
- Spinal Cord Injury, Intermittent Catheterization, Hydrophilic Catheter, Non-Hydrophilic Catheter, Quality of Life, Time, Preparation, Satisfaction
- Medical subject headings
- Spinal Cord Injuries, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPC - SpeediCath ®Device
Also called Intermittent catheterization using 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
Non-HPC - Self-Cath ®Device
Also called Intermittent catheterization using 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; Lubrication jelly (MUKO ®, 3.5g package, Cardinal Health Canada Inc, Toronto, ON, Canada) was provided
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Device: Non-HPC - Self-Cath ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Through study completion, an average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Dec 2018
- Primary completion10 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-by-two cross-over assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrei Krassioukov
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, International Collaboration on Repair Discoveries, Vancouver Coastal Health, Coloplast A/S
- Responsible party
- Sponsor-investigator, Andrei Krassioukov, University of British Columbia
- Investigators
- Andrei Krassioukov, MD, PhD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003999
- Sponsor's protocol ID
- H17-03228 - Part 2
- Other IDs
- COLO-AK-NLUTD-SCI
- Status last verified
- Aug 2021
- First submitted
- 22 Jun 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Burden of Intermittent Catheterization in Adult Individuals With Neurogenic Lower Urinary Tract Dysfunction Following Spinal Cord Injury - Part 2
- ClinicalTrials.gov ID
- NCT05003999
- Acronym / sponsor ID
- H17-03228 - Part 2
- Keywords
- Spinal Cord Injury, Intermittent Catheterization, Hydrophilic Catheter, Non-Hydrophilic Catheter, Quality of Life, Time, Preparation, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Andrei KrassioukovUniversity, hospital or other
- Collaborators
- University of British Columbia, International Collaboration on Repair Discoveries, Vancouver Coastal Health, Coloplast A/S
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-by-two cross-over assignment
| Arm | Type | Receives |
|---|---|---|
| Intermittent catheterization starting with a hydrophilic catheter (HPC) | Experimental | 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 i.e. SpeediCath ® (Coloplast A/S, Humlebæk, Denmark) |
| Intermittent catheterization starting with a non-hydrophilic catheter (non-HPC) | Active comparator | 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 i.e. Self-Cath ® (Coloplast A/S, Humlebæk, Denmark); Lubrication jelly (MUKO ®, 3.5g package, Cardinal Health Canada Inc, Toronto, ON, Canada) was provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- In addition to not fulfilling the inclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPC - SpeediCath ®Also: Intermittent catheterization using 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 | Device | Intermittent catheterization starting with a hydrophilic catheter (HPC) |
| Non-HPC - Self-Cath ®Also: Intermittent catheterization using 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; Lubrication jelly (MUKO ®, 3.5g package, Cardinal Health Canada Inc, Toronto, ON, Canada) was provided | Device | Intermittent catheterization starting with a non-hydrophilic catheter (non-HPC) |
Primary outcome
Differences in time needed to perform intermittent catheterization between two types of catheters
Time frame: 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).
Difference in convenience to perform intermittent catheterization between two types of catheters
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- ICORD is a spinal cord injury research centre of the UBC Faculty of Medicine and VCH Research Institute.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Krassioukov, MD, PhD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPC - SpeediCath ® and Non-HPC - Self-Cath ® in people with Spinal Cord Injuries and Neurogenic Lower Urinary Tract Dysfunction, run by Andrei Krassioukov at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in time needed to perform intermittent catheterization between two types of catheters (time frame: Through study completion, an average of two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.