Product Evaluation of a Newly Developed Intermittent Catheter.

Incontinence, Urinary Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966015
• Other study ID #: CP268
• Status: Completed
• Phase: N/A
• First received: November 15, 2016
• Last updated: February 2, 2018
• Start date: May 2016
• Est. completion date: June 2016

Study information

• Verified date: February 2018
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary
• Urinary Incontinence

Intervention

Device:
• Coloplast test catheter
This is a newly developed catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'.	1 week