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New Coating for Urinary Intermittent Catheters

NCT06985888 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-08-14

No results posted yet for this study

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.

Conditions

  • Retention, Urinary

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

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06985888 on ClinicalTrials.gov