Urinary IncontinenceCP341NCT05224544
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter
A study testing Investigational prototype device and Comparator device in people with Urinary Incontinence, run by Coloplast A/S at 1 site in United States.
Trial summary
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Read more about this study
- Who is it for?
- Ages 18 to 110 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Investigational prototype device and Comparator device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2022to 31 Mar 2022
- 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 to 110 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has given written informed consent
- Is at least 18 years and have full legal capacity
- Is female
- Has a negative urine Multistix dipstick test for erythrocytes (haematuria)
Who cannot join
- Has used an internal urinary catheter or cystoscopy within the past month
- Has prior history of bladder surgery
- Is symptomatic and/or on medication for overactive bladder
- Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate)
- Is pregnant and/or breast-feeding
- Is participating in other clinical investigations during this investigation
- Is menstruating during study period
Trial locations and contacts
1 site in 1 country.
United States1 site
American Health Research
Charlotte, North Carolina, 28277
About this study
Official title: Exploratory Study Investigating the Acute Effect of Intermittent Catheterization on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter Compared to a Conventional 2-eyelet Catheter
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which lasted up to 3 days (if Day 0 and Day 1 were not on same day). The subjects were randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product.
Read the detailed description
This investigation was a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.
- Conditions
- Urinary Incontinence
- Being tested
- Investigational prototype 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 prototype deviceDevice
Also called prototype microhole zone catheter
The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
Comparator deviceDevice
Also called "Infyna chic"
The comparator is a urinary catheter for bladder drainage through the urethra.
| Study group | Role | What they receive |
|---|---|---|
| Prototype Catheter | Experimental | Healthy volunteers to test the prototype intermittent catheter with a microhole zone. Receives: Device: Investigational prototype device |
| Comparator Catheter | Active comparator | Healthy volunteers to test the comparator intermittent catheter with two conventional eyelets. Receives: Device: Comparator device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.
Change in appearance of the bladder mucosa (∆=pre-catheterisation at baseline and post-catheterization and visit 2) rated on a 4-point scale.
The 4-point scale defined as such:
- no lesions evident;
- minor mucosal and blood vessel lesions;
- major blood vessel lesions, and
- major mucosal and blood vessel lesions,
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start31 Jan 2022
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Selwyn Spangenthal, MD, Principal investigator, American Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224544
- Sponsor's protocol ID
- CP341
- Acronym
- CP341
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2021
- Last updated
- 12 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Investigating the Acute Effect of Intermittent Catheterization on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter Compared to a Conventional 2-eyelet Catheter
- ClinicalTrials.gov ID
- NCT05224544
- Acronym / sponsor ID
- CP341 / CP341
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which lasted up to 3 days (if Day 0 and Day 1 were not on same day). The subjects were randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product.
Detailed description
This investigation was a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prototype Catheter | Experimental | Device: Investigational prototype deviceHealthy volunteers to test the prototype intermittent catheter with a microhole zone. |
| Comparator Catheter | Active comparator | Device: Comparator deviceHealthy volunteers to test the comparator intermittent catheter with two conventional eyelets. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has given written informed consent
- Is at least 18 years and have full legal capacity
- Is female
- Has a negative urine Multistix dipstick test for erythrocytes (haematuria)
Key exclusion criteria (7 listed)
- Has used an internal urinary catheter or cystoscopy within the past month
- Has prior history of bladder surgery
- Is symptomatic and/or on medication for overactive bladder
- Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate)
- Is pregnant and/or breast-feeding
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 prototype deviceAlso: prototype microhole zone catheterThe test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use. | Device | Prototype Catheter |
| Comparator deviceAlso: "Infyna chic"The comparator is a urinary catheter for bladder drainage through the urethra. | Device | Comparator Catheter |
Primary outcome
Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.
Time frame: 2 days
Change in appearance of the bladder mucosa (∆=pre-catheterisation at baseline and post-catheterization and visit 2) rated on a 4-point scale. The 4-point scale defined as such: 1. no lesions evident; 2. minor mucosal and blood vessel lesions; 3. major blood vessel lesions, and 4. major mucosal and blood vessel lesions,
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Selwyn Spangenthal, MD principal investigator
American Health Research
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 prototype device and Comparator device in people with Urinary Incontinence, run by Coloplast A/S at 1 site in United States.
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 4 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 12 Dec 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 United States. 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 13 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?
Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale. (time frame: 2 days). 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 12 Dec 2025.