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Product Evaluation of a Newly Developed Intermittent Catheter.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02966015
Recruitment Status : Completed
First Posted : November 17, 2016
Results First Posted : December 8, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Study Description
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Brief Summary:
The aim of the study is to investigate the navigation of a newly developed catheter.

Condition or disease Intervention/treatment Phase
Incontinence, Urinary Device: Coloplast test catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : May 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Testing the new Coloplast Test catheter
The subjects used the new Coloplast Test catheter for 1 week
 Device: Coloplast test catheter
This is a newly developed catheter


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Successfully Able to Insert Catheter [ Time Frame: 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'.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966015


Sponsors and Collaborators
Coloplast A/S
Investigators
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Study Chair: Camilla F Vibjerg, Msc Head of clinical operation
More Information
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT02966015    
Other Study ID Numbers: CP268
First Posted: November 17, 2016    Key Record Dates
Results First Posted: December 8, 2017
Last Update Posted: February 28, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders