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OpenTrials
Completed

NCT Number: NCT02966015

Product Evaluation of a Newly Developed Intermittent Catheter.

The aim of the study is to investigate the navigation of a newly developed catheter.

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Key information

Conditions

Incontinence, Urinary Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coloplast Test Catheter

Device

This is a newly developed catheter

Primary outcomes

  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'.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2016
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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