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Clinical Trials/NCT02965105
NCT02965105
Completed
N/A

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

Coloplast A/S1 site in 1 country28 target enrollmentNovember 2016
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ConditionsIncontinence, Urinary

Overview

Phase
N/A
Intervention
Not specified
Conditions
Incontinence, Urinary
Sponsor
Coloplast A/S
Enrollment
28
Locations
1
Primary Endpoint
Pain
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of the study is to test the performance and safety of a newly developed intermittent catheter

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
December 2016
Last Updated
9 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
  • •Have a negative urine multistix - erythrocytes (Microscopic haematuria)
  • •Have a negative urine multistix:
  • •Leukocytes
  • •Nitrite Or if positive, subsequent negative for bacterial growth in urine culture

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 clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
  • •Known hypersensitivity toward any of the test products -

Outcomes

Primary Outcomes

Pain

Time Frame: 1 day

Pain experienced by the subjects at catheterisation is measure with the VAS scale

Study Sites (1)

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