Urinary IncontinenceNCT05841004

Clinical Trial of New Single-use Compact Intermittent Catheter

A study testing Investigational device and Comparator device 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.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Urinary Incontinence
What is being tested?: Investigational device and Comparator device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteDenmark
Study dates: 20 Jun 2023to 14 Sep 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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Is Female
Is at least 18 years of age and has full legal capacity
Has signed an informed consent form
Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying
Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study
Has the ability (assessed by investigator) and willingness to follow study procedures or is able to use a compact catheter assessed by investigator

Who cannot join

Is participating in any other clinical study during this investigation
Has previously participated in this study
Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id)
Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris
Has any known allergies towards ingredients in the investigational device
Is pregnant
Is breastfeeding

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Odense Universitetshospital
Odense, 5000

Other trials in Denmark

About this study

Official title: A Randomized, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter vs. Infyna Chic in a Pop-ulation of Adult Female Intermittent Catheter Users.

The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.

The total study duration for the individual subject will be up to 14 days.

Conditions: Urinary Incontinence
Being tested: Investigational device, Comparator device
Medical subject headings: Urinary Incontinence

What participants receive

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

Investigational deviceDevice
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.
Comparator deviceDevice
Hollister Infyna Chic, single-use compact catheter.

Study groups in NCT05841004
Study group	Role	What they receive
Investigational device - newly developed intermittent compact catheter	Experimental	Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Receives: Device: Investigational device; Device: Comparator device
Hollister Infyna Chic	Active comparator	The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter. Receives: Device: Investigational device; Device: Comparator device

What is being measured

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

Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, [mL]
Measured: At Visit 1 and Visit 2

Secondary outcomes (3)

Number of Flowstops (Catheterisation Performed by a Healthcare Professional)
Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), [number].
Measured: At Visit 1 and Visit 2
Residual Volume Post Catheterisation
Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL],
Measured: At Visit 1 and Visit 2
Number of Adverse Events
Count number of Adverse events, [number]
Measured: At Visit 1 and Visit 2

Timeline

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

20 Jun 202314 Sep 2023

First posted3 May 2023
Study start20 Jun 2023
Primary completion14 Sep 2023
Study completion14 Sep 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Model description: controlled crossover study
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05841004
Sponsor's protocol ID: CP356
Status last verified: Dec 2024
First submitted: 24 Mar 2023
Last updated: 23 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter vs. Infyna Chic in a Pop-ulation of Adult Female Intermittent Catheter Users.
ClinicalTrials.gov ID: NCT05841004
Acronym / sponsor ID: CP356
Conditions: Urinary Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: 20 Jun 2023 (actual)
Primary completion: 14 Sep 2023 (actual)
Study completion: 14 Sep 2023 (actual)
First posted: 3 May 2023 (actual)
Results: Posted 23 Jan 2025

Clinical summary

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

The total study duration for the individual subject will be up to 14 days.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: controlled crossover study

Arm	Type	Receives
Investigational device - newly developed intermittent compact catheter	Experimental	Device: Investigational device, Device: Comparator deviceReady-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use.
Hollister Infyna Chic	Active comparator	Device: Investigational device, Device: Comparator deviceThe comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.

Who may qualify

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

Key inclusion criteria (7 listed)

Is Female
Is at least 18 years of age and has full legal capacity
Has signed an informed consent form
Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying

Key exclusion criteria (7 listed)

Is participating in any other clinical study during this investigation
Has previously participated in this study
Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id)
Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris
Has any known allergies towards ingredients in the investigational device

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
Investigational deviceReady-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.	Device	Hollister Infyna Chic, Investigational device - newly developed intermittent compact catheter
Comparator deviceHollister Infyna Chic, single-use compact catheter.	Device	Hollister Infyna Chic, Investigational device - newly developed intermittent compact catheter

Primary outcome

Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
Time frame: At Visit 1 and Visit 2
Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, [mL]

3 secondary outcomes

Number of Flowstops (Catheterisation Performed by a Healthcare Professional)
Time frame: At Visit 1 and Visit 2
Residual Volume Post Catheterisation
Time frame: At Visit 1 and Visit 2
Number of Adverse Events
Time frame: At Visit 1 and Visit 2

Results and safety

Results posted to the registry on 23 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Device First, Then Hollister Infyna Chic	37	36
Hollister Infyna Chic, Then Investigational Device	36	36

Primary outcome: Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)

Time frame: At Visit 1 and Visit 2. Least squares mean (95% Confidence Interval). Unit: mL

Measure	Investigational Device - Newly Developed Intermittent Compact Catheter n = 72	Hollister Infyna Chic n = 72
Value	15.3 (3.7 to 26.9)	23.7 (10.8 to 37.0)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were registered from the individual's enrolment until termination in the study. The total study duration for the individual subject was between two days to two weeks, consisting of three site visits (V0-V2).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Device - Newly Developed Intermittent Compact Catheter	0 of 73 (0%)	1 of 73 (1.4%)	0 of 73
Hollister Infyna Chic	0 of 72 (0%)	1 of 72 (1.4%)	0 of 72

Limitations and caveats (from the sponsor): The natural distribution of residual volume at 1st flow-stop values skews positively. This carries a high risk of influence by random occurrences of extreme values. These can occur without systematic relation to product or subject and can obscure interpretability of the analysis. To counter this effect, post hoc responder analyses were included, testing the benefit of treatment through the proportion of individuals who achieve the desired outcome, i.e., complete and effective bladder drainage.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Urinary Incontinence

Recruiting
Safety and Performance of UCon Patch Electrode
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Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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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, MD principal investigator

Odense 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 Investigational device and Comparator device 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 7 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 23 Jan 2025. 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 23 Jan 2025). 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?

Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) (time frame: At Visit 1 and Visit 2). 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 NCT05841004.

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 23 Jan 2025.