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Clinical Trials/NCT01800903
NCT01800903
Completed
N/A

Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers

Coloplast A/S1 site in 1 country40 target enrollmentFebruary 2013
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ConditionsIntermittent Urethral Catheterization

Overview

Phase
N/A
Intervention
Not specified
Conditions
Intermittent Urethral Catheterization
Sponsor
Coloplast A/S
Enrollment
40
Locations
1
Primary Endpoint
Overall Discomfort During Catheterization
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
April 2013
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Have given written informed consent and signed letter of authority
  • •Be at least 18 years of age and have full legal capacity
  • •Willing to refrain from using analgetics up to 24 hours prior to catheterization visits

Exclusion Criteria

  • •Abnormalities, diseases or surgical procedures performed in the lower urinary tract
  • •Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
  • •Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)
  • •Known hypersensitivity toward any of the test products -

Outcomes

Primary Outcomes

Overall Discomfort During Catheterization

Time Frame: 1 day

Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.

Study Sites (1)

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