Product Evaluation of a Newly Developed Intermittent Catheter.

Coloplast A/S0 sites153 target enrollmentMay 2016

ConditionsIncontinence, Urinary

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Incontinence, Urinary
Sponsor: Coloplast A/S
Enrollment: 153
Primary Endpoint: Number of Participants Successfully Able to Insert Catheter
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

June 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Coloplast A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and at least 18 years
•Has used Intermittent self-catheterization at least 3 months
•Has normal to slightly reduced hand mobility
•Use catheter size CH12 or CH14 (must use same size during product evaluation)

Exclusion Criteria

•Currently receiving treatment for urinary tract infection
•Currently receiving chemotherapy

Outcomes

Primary Outcomes

Number of Participants Successfully Able to Insert Catheter

Time Frame: 1 week

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'.