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Completed NCT06985888

New Coating for Urinary Intermittent Catheters

Conditions: Retention, Urinary

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 32
Sponsor: Coloplast A/S

Location: Department of Urology, Rigshospitalet Copenhagen

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06985888). StuddyBuddy aggregates publicly available trial information.