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COMPLETED
NCT06985888
NA

New Coating for Urinary Intermittent Catheters

Sponsor: Coloplast A/S

View on ClinicalTrials.gov

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

Interventions

DEVICE

SpeediCath® Standard male new coating

Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male new coating CH12 by HCP

DEVICE

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