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NCT02966015 Clinical Trial

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
Secondary ID
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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