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
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