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New Coating for Urinary Intermittent Catheters
Sponsor: Coloplast A/S
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.
Official title: Clinical Investigation of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-05-06
Completion Date
2025-06-30
Last Updated
2026-08-24
Healthy Volunteers
Yes
Conditions
Interventions
SpeediCath® Standard male new coating
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male new coating CH12 by HCP
SpeediCath® Standard male
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male CH 12 by HCP
Locations (1)
Department of Urology, Rigshospitalet
Copenhagen, Denmark