Product Evaluation of a Newly Developed Intermittent Catheter.
Not Applicable
Completed
- Conditions
- Incontinence, Urinary
- Interventions
- Device: Coloplast test catheter
- Registration Number
- NCT02966015
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The aim of the study is to investigate the navigation of a newly developed catheter.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 153
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Testing the new Coloplast Test catheter Coloplast test catheter The subjects used the new Coloplast Test catheter for 1 week
- Primary Outcome Measures
Name Time Method Number of Participants Successfully Able to Insert Catheter 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'.
- Secondary Outcome Measures
Name Time Method