Retention, UrinaryNCT06985888
New Coating for Urinary Intermittent Catheters
A study testing SpeediCath® Standard male new coating and SpeediCath® Standard male in people with Retention, Urinary, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The goal is to confirm, that the newly developed coating is non-inferior to the comparator with respect to the overall discomfort of the catheterisation (assessed by participant). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Retention, Urinary
- What is being tested?
- SpeediCath® Standard male new coating and SpeediCath® Standard male
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2025to 30 Jun 2025
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Has self-assessed intact male anatomy with no abnormalities or disease of the lower urinary tract or any surgical procedures performed in the lower urinary tract
- Is able (assessed by investigator) and willing to adhere to study procedures during study duration.
- Is able to refrain from using analgesics up to 24 hours prior to catheterisation visits
- Is negative for haematuria, measured by urine dipstick test of erythrocytes
Who cannot join
- Is participating in any other clinical investigation during this investigation, which could affect the results of this investigation, as assessed by investigator.
- Has previously been randomized in this investigation.
- Has known hypersensitivity towards any of the devices used in the investigation
- Is currently experiencing symptoms associated with UTI, as assessed by investigator.
- Has known impaired sensation of the urethra
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
The goal is to confirm, that the newly developed coating is non-inferior to the comparator with respect to the overall discomfort of the catheterisation (assessed by participant).
Participants will attend 3 study site visits and will be catheterised by a HCP at visit 1 and 2 with one of the two catheters in randomisation order. Urine samples will be collected pre- and post catheterisation for assessments.
Read the detailed description
The primary objective of the study is to confirm that the newly developed investigational coating is non-inferior to the comparator coating with respect to the overall discomfort of catheterisation.
The investigational device is a ready-to-use, sterile, hydrophilic-coated Nelaton male catheter for intermittent catheterisation and based on the standard SpeediCath® male intermittent catheter with a difference in the composition on the coating.
The study is a double-blinded, randomized, crossover study including 32 randomized healthy male volunteers. The total study duration for the individual subject will be between 4-21 days and consists of 3 site visits V0, V1 and V2, and V0 andV1 can be combined
At V1 and V2 the subjects will be catheterized in a hospital setting by a health care professional, with one of the two catheters in a randomized order. Subject will be asked to assess the overall discomfort of the catheterisation on VAS.
- Conditions
- Retention, Urinary
- Being tested
- SpeediCath® Standard male new coating, SpeediCath® Standard male
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpeediCath® Standard male new coatingDevice
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male new coating CH12 by HCP
SpeediCath® Standard maleDevice
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male CH 12 by HCP
| Study group | Role | What they receive |
|---|---|---|
| Catheterisation with investigational device and Comparator | Other | Not described Receives: Device: SpeediCath® Standard male new coating; Device: SpeediCath® Standard male |
| Catheterisation with Comparator and Investigational device | Other | Not described Receives: Device: SpeediCath® Standard male new coating; Device: SpeediCath® Standard male |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Overall Discomfort During Catheterization Was Measured by VAS on a 10 cm Scale Ranging From "no Discomfort" (0 cm) to "Worst Possible Discomfort" (10 cm) Caused by the Catheter.
This endpoint was assessed by the subject immediately after completed catheterization, by setting a vertical line to indicate their experience of the overall catheterization.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start6 May 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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 Retention, UrinaryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985888
- Sponsor's protocol ID
- CP372
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2025
- Last updated
- 24 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06985888
- Acronym / sponsor ID
- CP372
- Conditions
- Retention, Urinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Posted 24 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to confirm, that the newly developed coating is non-inferior to the comparator with respect to the overall discomfort of the catheterisation (assessed by participant).
Participants will attend 3 study site visits and will be catheterised by a HCP at visit 1 and 2 with one of the two catheters in randomisation order. Urine samples will be collected pre- and post catheterisation for assessments.
Detailed description
The primary objective of the study is to confirm that the newly developed investigational coating is non-inferior to the comparator coating with respect to the overall discomfort of catheterisation.
The investigational device is a ready-to-use, sterile, hydrophilic-coated Nelaton male catheter for intermittent catheterisation and based on the standard SpeediCath® male intermittent catheter with a difference in the composition on the coating.
The study is a double-blinded, randomized, crossover study including 32 randomized healthy male volunteers. The total study duration for the individual subject will be between 4-21 days and consists of 3 site visits V0, V1 and V2, and V0 andV1 can be combined
At V1 and V2 the subjects will be catheterized in a hospital setting by a health care professional, with one of the two catheters in a randomized order. Subject will be asked to assess the overall discomfort of the catheterisation on VAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheterisation with investigational device and Comparator | Other | Device: SpeediCath® Standard male new coating, Device: SpeediCath® Standard male |
| Catheterisation with Comparator and Investigational device | Other | Device: SpeediCath® Standard male new coating, Device: SpeediCath® Standard male |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Has self-assessed intact male anatomy with no abnormalities or disease of the lower urinary tract or any surgical procedures performed in the lower urinary tract
- Is able (assessed by investigator) and willing to adhere to study procedures during study duration.
Key exclusion criteria (5 listed)
- Is participating in any other clinical investigation during this investigation, which could affect the results of this investigation, as assessed by investigator.
- Has previously been randomized in this investigation.
- Has known hypersensitivity towards any of the devices used in the investigation
- Is currently experiencing symptoms associated with UTI, as assessed by investigator.
- Has known impaired sensation of the urethra
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 |
|---|---|---|
| SpeediCath® Standard male new coatingIntermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male new coating CH12 by HCP | Device | Catheterisation with Comparator and Investigational device, Catheterisation with investigational device and Comparator |
| SpeediCath® Standard maleIntermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male CH 12 by HCP | Device | Catheterisation with Comparator and Investigational device, Catheterisation with investigational device and Comparator |
Primary outcome
The Overall Discomfort During Catheterization Was Measured by VAS on a 10 cm Scale Ranging From "no Discomfort" (0 cm) to "Worst Possible Discomfort" (10 cm) Caused by the Catheter.
Time frame: Immediately after the procedure
This endpoint was assessed by the subject immediately after completed catheterization, by setting a vertical line to indicate their experience of the overall catheterization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpeediCath® Standard male new coating and SpeediCath® Standard male in people with Retention, Urinary, 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 5 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 24 Aug 2026. 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 24 Aug 2026). 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?
The Overall Discomfort During Catheterization Was Measured by VAS on a 10 cm Scale Ranging From "no Discomfort" (0 cm) to "Worst Possible Discomfort" (10 cm) Caused by the Catheter. (time frame: Immediately after the procedure). 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 24 Aug 2026.