Product Evaluation of a Newly Developed Intermittent Catheter.
Primary Purpose
Incontinence, Urinary
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coloplast test catheter
Sponsored by
About this trial
This is an interventional supportive care trial for Incontinence, Urinary
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Testing the new Coloplast Test catheter
Arm Description
The subjects used the new Coloplast Test catheter for 1 week
Outcomes
Primary Outcome Measures
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'.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02966015
Brief Title
Product Evaluation of a Newly Developed Intermittent Catheter.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to investigate the navigation of a newly developed catheter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urinary
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testing the new Coloplast Test catheter
Arm Type
Experimental
Arm Description
The subjects used the new Coloplast Test catheter for 1 week
Intervention Type
Device
Intervention Name(s)
Coloplast test catheter
Intervention Description
This is a newly developed catheter
Primary Outcome Measure Information:
Title
Number of Participants Successfully Able to Insert Catheter
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla F Vibjerg, Msc
Organizational Affiliation
Head of clinical operation
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Product Evaluation of a Newly Developed Intermittent Catheter.
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