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Completed

NCT Number: NCT00990093

A Randomised, Cross-over, Open-labelled Test Catheter Acceptance Study

The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Klinik for Rygmarvsskader

Hornbæk, 3100, Denmark

About this study

See brief summary

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age
  • Has normal/impaired sensation in the urethra
  • Self-catheterises at least 4 times per day
  • Has used clean self-intermittent catheterisation for at least 14 days
  • Is able to open and prepare the catheters for catheterisation
  • Has signed the informed consent before any study related-activities.

Exclusion criteria

  • Has a symptomatic urinary tract infection as assessed by the investigator
  • Is mentally unstable as assessed by the investigator

Treatment and study plan

test intermittent catheter

Device

CH 12 hydrophilic coated catheter

Other names: Test catheter

Intermittent catheterization

Device

CH 12 hydrophilic catheter

Other names: SpeediCath

Primary outcomes

  1. Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.

    Time frame: 14 days

    Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.

    At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 6, 2009
Registry last updated
Sep 5, 2012

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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