Safety and Performance of a New Coating for Urinary Intermittent Catheters

Coloplast A/S40 enrolled

Overview

The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intermittent Urethral Catheterization

Interventions

ZN-D catheterDEVICE

ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.

ZN-C catheterDEVICE

ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.

SpeediCath catheterDEVICE

The Speedicath cathere is CE-marked and commercially available.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits Exclusion Criteria: 1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract 2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination) 3. Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period) 4. Known hypersensitivity toward any of the test products -

Locations (1)

Department of Urology

Copenhagen, Denmark

Outcomes

Primary Outcomes

Overall Discomfort During Catheterization

Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.

Time frame: 1 day

Data from ClinicalTrials.gov

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