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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
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Incontinence, Urinary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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

    First Posted
    November 15, 2016
    Last Updated
    February 2, 2018
    Sponsor
    Coloplast A/S
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    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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