Incontinence, Urinary
Conditions
Brief summary
The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.
Interventions
DEVICEColoplast Test Catheter
Newly developed intermittent catheter
DEVICEColoplast Speedicath
Marketed Coloplast Speedicath catheter
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. Have a negative urine multistix - erythrocytes (Microscopic haematuria) 6. Have a negative urine multistix: * Leukocytes * Nitrite Or if positive, subsequent negative for bacterial growth in urine culture
Exclusion criteria
1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract 2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination) 3. Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation 4. Known hypersensitivity toward any of the test products -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 1 day | The VAS scale is used to measure the pain experienced by the subjects at catheterisation |
Countries
Denmark
Outcome results
None listed