Urinary IncontinenceNCT05814211

Clinical Trial of New Intermittent Single-use Catheter

A study testing Investigational device - newly developed intermittent catheter, Comparator device #1 - SpeediCath Eve and Comparator device #2 - SpeediCath Compact Plus Female in people with Urinary Incontinence, run by Coloplast A/S at 11 sites in 3 countries.

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 - newly developed intermittent catheter, Comparator device #1 - SpeediCath Eve and Comparator device #2 - SpeediCath Compact Plus Female
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 11 sitesin 3 countries
Study dates: 4 Aug 2023to 29 Nov 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

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

11 sites in 3 countries.

Country

City, postcode or hospital

11 sites in 3 countries

Denmark4 sites

Rigshopsitalet
Copenhagen, København Ø, 2100
Sanos Clinic
Gandrup, North Denmark, 9362
Odense Universitetshospital
Odense, 5000
Sanos Clinic Vejle
Vejle, 7100

Other trials in Denmark

United Kingdom4 sites

Synexus Birmingham
Birmingham
North Bristol NHS Trust
Bristol
Addenbrookes
Cambridge
Synexus Merseyside
Liverpool

Other trials in United Kingdom

France3 sites

Hôpital Saint- Philibert
Lille
Hôpital Tenon
Paris, 75020
CHU Toulouse Rangueil
Toulouse

Other trials in France

About this study

Official title: A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users

A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.

Conditions: Urinary Incontinence
Being tested: Investigational device - newly developed intermittent catheter, Comparator device #1 - SpeediCath Eve, Comparator device #2 - SpeediCath Compact Plus Female
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 device - newly developed intermittent catheterDevice
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 device #1 - SpeediCath EveDevice
During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.
Comparator device #2 - SpeediCath Compact Plus FemaleDevice
During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.
Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.

Study groups in NCT05814211
Study group	Role	What they receive
Investigational device - newly developed intermittent 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. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Receives: Device: Investigational device - newly developed intermittent catheter
Comparator device (#1 OR #2)	Active comparator	SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period. Receives: Device: Comparator device #1 - SpeediCath Eve; Device: Comparator device #2 - SpeediCath Compact Plus Female

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)
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Measured: Tested at site visit after 14 days of device home use.

Secondary outcomes (5)

Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP)
Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional)
Measured: Tested at site visit after 14 days of device home use.
Number of Flow-stops (Catheterisation Profile, Self-catheterisation)
Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)
Measured: Tested at site visit after 14 days of device home use.
Residual Volume at 1st Flow-stop
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (self-catheterisation)
Measured: Tested at site visit after 14 days of device home use.
Average Residual Volume Post Catheterisation (Bladder Scan)
Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)
Measured: Tested at site visit after 14 days of device home use.
Number of Adverse Events
Number of Adverse events (number)
Measured: From Week 0-4

Timeline

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

4 Aug 202329 Nov 2023

First posted14 Apr 2023
Study start4 Aug 2023
Primary completion29 Nov 2023
Study completion29 Nov 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05814211
Sponsor's protocol ID: CP348
Status last verified: Jan 2025
First submitted: 31 Mar 2023
Last updated: 20 Feb 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 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users
ClinicalTrials.gov ID: NCT05814211
Acronym / sponsor ID: CP348
Conditions: Urinary Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: 4 Aug 2023 (actual)
Primary completion: 29 Nov 2023 (actual)
Study completion: 29 Nov 2023 (actual)
First posted: 14 Apr 2023 (actual)
Results: Posted 20 Feb 2025

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Investigational device - newly developed intermittent catheter	Experimental	Device: Investigational device - newly developed intermittent catheterReady-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.
Comparator device (#1 OR #2)	Active comparator	Device: Comparator device #1 - SpeediCath Eve, Device: Comparator device #2 - SpeediCath Compact Plus FemaleSpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked Coloplast products. Randomization will decide the order of investigational device/comparator device and which of the two comparator devices the subject will receive in the comparator study period.

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 device - newly developed intermittent catheterReady-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.	Device	Investigational device - newly developed intermittent catheter
Comparator device #1 - SpeediCath EveDuring comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one. Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.	Device	Comparator device (#1 OR #2)
Comparator device #2 - SpeediCath Compact Plus FemaleDuring comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one. Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The comparator device is for single use.	Device	Comparator device (#1 OR #2)

Primary outcome

Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
Time frame: Tested at site visit after 14 days of device home use.
Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional)

5 secondary outcomes

Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP)
Time frame: Tested at site visit after 14 days of device home use.
Number of Flow-stops (Catheterisation Profile, Self-catheterisation)
Time frame: Tested at site visit after 14 days of device home use.
Residual Volume at 1st Flow-stop
Time frame: Tested at site visit after 14 days of device home use.
Average Residual Volume Post Catheterisation (Bladder Scan)
Time frame: Tested at site visit after 14 days of device home use.
Number of Adverse Events
Time frame: From Week 0-4

Results and safety

Results posted to the registry on 20 Feb 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 Comparator Device	40	39
Comparator Device First Then Investigational Device	41	40

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

Time frame: Tested at site visit after 14 days of device home use.. Least squares mean (95% Confidence Interval). Unit: milliliters

Measure	Investigational Device - Newly Developed Intermittent Catheter n = 79	Comparator Device n = 79
Value	23.22 (4.65 to 41.80)	15.87 (6.09 to 25.65)

Population analysed: The study protocol pre-specified that the comparator arm of the study would combine an equal split between two similar conventional-eyelet catheters, to achieve a comparator arm representing this class of devices as closely as possible. Subjects were randomized to receive either one of the comparator products; either SpeediCath Eve or SpeediCath Compact Plus Female (CH12 and CH14). Both comparators are CE marked products produced by Coloplast.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Device - Newly Developed Intermittent Catheter	0 of 81 (0%)	10 of 81 (12.3%)	0 of 81
Comparator Device	0 of 81 (0%)	13 of 81 (16%)	0 of 81

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 20 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

11 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Denmark, United Kingdom, France. 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 20 Feb 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: Tested at site visit after 14 days of device home use.). 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 NCT05814211.

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 20 Feb 2025.