Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT02965066
Eligibility Criteria:
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 -
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02965066
Study Brief:
Protocol Section:
NCT02965066