CompletedNot Applicable

New Coating for Urinary Intermittent Catheters

Denmark32 participantsStarted 2025-05-06

Plain-language 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). 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.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Overall discomfort of the catheterisation

Timeframe: immediately after the procedure

Trial details

NCT IDNCT06985888

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Retention, Urinary trials