An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization

A study testing CLINY catheter in people with Urinary Incontinence, run by Coloplast A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urinary Incontinence
What is being tested?: CLINY catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteDenmark
Study dates: 12 Aug 2022to 30 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

≥18 years of age and has full legal capacity
Signed informed consent form
Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion
Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product
Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion

Who cannot join

Participation in any other clinical intervention study during this investigation
Previous participation in this investigation
Any known allergies towards ingredients in the investigational device
Symptoms of UTI at time of inclusion, as judged by the investigator
Antibiotic treatment within 2 weeks prior to the Baseline visit (V1)
Pregnancy
Breastfeeding

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Odense Universitetshospital
Odense, 5000

Other trials in Denmark

About this study

The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.

Read the detailed description

Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management.

Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.

Conditions: Urinary Incontinence
Being tested: CLINY catheter
Medical subject headings: Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CLINY catheterDevice
Subjects using a single use catheter for bladder management at inclusion. During the study period, subjects will use the reusable CLINY catheter for 28 test-days

Study groups in NCT05626686
Study group	Role	What they receive
CLINY reusable catheter 28 days	Experimental	The investigation is designed as an open-labelled, single-arm investigation, in which the reuse CLINY catheter will be compared to single use catheters at baseline. Receives: Device: CLINY catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.
The Intermittent Self-Catheterization Questionnaire is a validated, self-reported questionnaire which is scored on a 5-point Likert scale and is translated to a value ranging from 0 (strongly disagree) to 4 (strongly agree) with higher values corresponding to greater Health-related Quality of Life. The aggregate scores across domains and the total score are calculated by averaging and multiplying by 25 to achieve a 100-point scale. Change = (Termination score - Baseline score)
Measured: Baseline (day 0) and Termination (day 28).

Secondary outcomes (1)

Adverse Events
Number of Adverse Events during the study
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 202230 Mar 2023

First posted25 Nov 2022
Study start12 Aug 2022
Primary completion30 Mar 2023
Study completion30 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urinary IncontinenceStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Model description: The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05626686
Sponsor's protocol ID: CP352
Status last verified: Oct 2023
First submitted: 25 Aug 2022
Last updated: 15 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
ClinicalTrials.gov ID: NCT05626686
Acronym / sponsor ID: CP352
Conditions: Urinary Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: 12 Aug 2022 (actual)
Primary completion: 30 Mar 2023 (actual)
Study completion: 30 Mar 2023 (actual)
First posted: 25 Nov 2022 (actual)
Results: Posted 15 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.

Detailed description

Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.

Arm	Type	Receives
CLINY reusable catheter 28 days	Experimental	Device: CLINY catheterThe investigation is designed as an open-labelled, single-arm investigation, in which the reuse CLINY catheter will be compared to single use catheters at baseline.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

≥18 years of age and has full legal capacity
Signed informed consent form
Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion
Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product
Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion

Key exclusion criteria (7 listed)

Participation in any other clinical intervention study during this investigation
Previous participation in this investigation
Any known allergies towards ingredients in the investigational device
Symptoms of UTI at time of inclusion, as judged by the investigator
Antibiotic treatment within 2 weeks prior to the Baseline visit (V1)

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
CLINY catheterSubjects using a single use catheter for bladder management at inclusion. During the study period, subjects will use the reusable CLINY catheter for 28 test-days	Device	CLINY reusable catheter 28 days

Primary outcome

Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.
Time frame: Baseline (day 0) and Termination (day 28).
The Intermittent Self-Catheterization Questionnaire is a validated, self-reported questionnaire which is scored on a 5-point Likert scale and is translated to a value ranging from 0 (strongly disagree) to 4 (strongly agree) with higher values corresponding to greater Health-related Quality of Life. The aggregate scores across domains and the total score are calculated by averaging and multiplying by 25 to achieve a 100-point scale. Change = (Termination score - Baseline score)

1 secondary outcome

Adverse Events
Time frame: 28 days

Results and safety

Results posted to the registry on 15 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CLINY Reusable Catheter	39	33

Primary outcome: Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score.

Time frame: Baseline (day 0) and Termination (day 28).. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	CLINY Reusable Catheter n = 33
Baseline visit	79.09 (73.69 to 84.49)
Termination visit	56.66 (51.26 to 62.06)

Population analysed: The full analysis set constituted all subjects enrolled who had been exposed to at least one device, with at least one endpoint recorded (data non-missing).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CLINY Reusable Catheter	0 of 39 (0%)	8 of 39 (20.5%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Urinary Incontinence

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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.

Karin Andersen principal investigator

Odense Universitetshospital

Nessn Azawi principal investigator

Zealand University Hospital

Brian Kloster principal investigator

Ålborg Universitetshospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CLINY catheter in people with Urinary Incontinence, run by Coloplast A/S at 1 site in Denmark.

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 5 inclusion and 7 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 15 Apr 2024. 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 Denmark. 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?

Yes. Results are posted in the registry (first posted 15 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score. (time frame: Baseline (day 0) and Termination (day 28).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05626686.

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 15 Apr 2024.