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:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT05785858
Eligibility Criteria:
Inclusion Criteria:
1. Document informed consent
2. Age ≥ 18 years at time of study entry
3. Indwelling urethral catheter use for at least the 3 months prior to study enrollment.
4. Able to read, write, and speak English
Exclusion Criteria:
1. Indwelling Foley catheter user for shorter than 3 months
2. Treatment for a urinary tract infection within 30 days prior to insertion of the Flume catheter, or reporting signs or symptoms of urinary tract infection at the time of catheter change, in the opinion of the treating clinician or site principal investigator.
3. Unable to read/write English at a 6th grade level
4. Neurologic diagnoses which could decrease/impair bladder sensation (e.g., spinal cord injury, multiple sclerosis)
5. History of bladder augmentation or urinary diversion
6. Existing catheter related genital adverse effects (e.g., meatal erosion)
7. Current use of indwelling catheter larger than 18 Fr in size
8. Otherwise unable to participate in or complete study procedures, in the opinion of the principal investigator.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05785858
Study Brief:
Protocol Section:
NCT05785858