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OpenTrials
Completed

NCT Number: NCT00832078

Test Catheter Pilot Study in Healthy Volunteers

The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshopsitalet

Copenhagen, København Ø, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years or older
  • Male
  • Signed informed consent
  • Negative urine multistix

Exclusion criteria

  • Abnormalities, diseases or surgical procedures performed in the lower urinary tract

Treatment and study plan

SpeediCath Compact Male

Device

CH 12 hydrophilic coated intermitten compact catheter

SpeediCath

Device

CH 12 hydrophilic coated intermittent coated catheter

Primary outcomes

  1. Discomfort

    Time frame: After each catheterisation

    Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)

Secondary outcomes

  1. Handling

    Time frame: After each catheterisation

  2. Preference

    Time frame: At study termination

  3. Haematuria

    Time frame: After each catheterisation

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Acronym: Test catheter

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 29, 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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