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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT05485935
Eligibility Criteria:
Inclusion Criteria:
1. Male
2. Was at least 18 years of age and had full legal capacity
3. Had given written informed consent
4. Had signed letter of authority (only DK)
5. Had used clean intermittent self-catheterization (CISC) for at least the last 3 months
6. Had used intermittent catheterization as the only bladder emptying method for at least the last 3 months
7. Self-catheterized using Coloplast SpeediCath Flex or Hollister VaPro catheters, CH12 or CH14, for at least 3 months prior to inclusion
8. Had the ability (assessed by investigator) and willingness to adhere to a 2-month study period
Exclusion Criteria
1. Participation in any other clinical study during this investigation
2. Previous participation in the study
3. Symptoms of urinary tract infection as judged by the investigator (rescheduling allowed within recruitment period for LPI)
4. Individuals with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
5. Any known allergies towards ingredients in the investigational device
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05485935
Study Brief:
Protocol Section:
NCT05485935