Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers
Not Applicable
Completed
- Conditions
- Incontinence, Urinary
- Registration Number
- NCT02965066
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
Inclusion Criteria
-
Have given written informed consent and signed letter of authority
-
Be at least 18 years of age and have full legal capacity
-
Be a male
-
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 -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Pain 1 day The VAS scale is used to measure the pain experienced by the subjects at catheterisation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Coppenhagen, Denmark
Rigshospitalet🇩🇰Coppenhagen, Denmark