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Clinical Trials/NCT00832078
NCT00832078
Completed
N/A

Test Catheter Pilot Study in Healthy Volunteers

Coloplast A/S1 site in 1 country28 target enrollmentJanuary 2009
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ConditionsHealthy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy
Sponsor
Coloplast A/S
Enrollment
28
Locations
1
Primary Endpoint
Discomfort
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
April 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • Handling(After each catheterisation)
  • Preference(At study termination)
  • Haematuria(After each catheterisation)

Study Sites (1)

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