Product Evaluation of a Newly Developed Intermittent Catheter.

N/ACompletedNCT02966015

Coloplast A/S153 enrolled

Overview

The aim of the study is to investigate the navigation of a newly developed catheter.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

153

Conditions

Incontinence, Urinary

Interventions

Coloplast test catheterDEVICE

This is a newly developed catheter

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and at least 18 years 2. Has used Intermittent self-catheterization at least 3 months 3. Has normal to slightly reduced hand mobility 4. Use catheter size CH12 or CH14 (must use same size during product evaluation) Exclusion Criteria: 1. Currently receiving treatment for urinary tract infection 2. Currently receiving chemotherapy

Outcomes

Primary Outcomes

Number of Participants Successfully Able to Insert Catheter

The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.

Time frame: 1 week

Data from ClinicalTrials.gov

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