Can a new coating make catheterization less uncomfortable?
NCT ID NCT06985888
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial tests whether a newly developed coating for urinary catheters causes less discomfort during catheterization compared to a standard catheter. Healthy male volunteers will be catheterized by a healthcare professional using both catheters in random order, and they will rate their overall discomfort on a scale. The goal is to confirm the new coating is not worse than the standard one in terms of comfort.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A new coating for urinary intermittent catheters
- What this could lead to
- If successful, this could lead to a more comfortable urinary catheter for people who need intermittent catheterization.
- What could go wrong
- This is a small early-stage study in healthy volunteers, so results may not apply to patients with urinary retention. The new coating might not prove more comfortable than the standard one.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
32 people
The number who actually took part.
- Started
-
May 2025
- Finished
-
Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Has given written informed consent 2. Is at least 18 years old 3. Has full legal capacity 4. 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 5. Is able (assessed by investigator) and willing to adhere to study procedures during study duration. 6. Is able to refrain from using analgesics up to 24 hours prior to catheterisation visits 7. Is negative for haematuria, measured by urine dipstick test of erythrocytes Exclusion Criteria: 1. Is participating in any other clinical investigation during this investigation, which could affect the results of this investigation, as assessed by investigator. 2. Has previously been randomized in this investigation. 3. Has known hypersensitivity towards any of the devices used in the investigation 4. Is currently experiencing symptoms associated with UTI, as assessed by investigator. 5. Has known impaired sensation of the urethra
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Retention, urinary are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Department of Urology, Rigshospitalet
Copenhagen, 2100, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.