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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT02198833
Eligibility Criteria:
Inclusion Criteria
* Veteran
* Hospitalized in one of the two participating Spinal Cord Injury Units
* Require a size 14, 16, or 18 French catheter
* Sign and date the written informed consent document acknowledging his/her desire to participate in the study, or if unable to sign due to spinal cord injury give verbal consent in front of two impartial witnesses who sign and date the informed consent document in the presence of the participant
* Be able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
* Require insertion or exchange of a Foley catheter for no longer than 15 days.
Exclusion Criteria
* Unable to provide informed consent
* Has a current symptomatic urinary tract infection
* Has persistent bacteriuria that cannot be cleared with antimicrobial agents to a nominal level of less than 1,000 Colony Forming Units/mL prior to study catheter insertion
* Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
* Has periurethral inflammation or infection
* Has a known urethral anatomical anomaly which makes catheterization difficult
* Has a known silicone allergy or sensitivity
* Cannot accommodate a size 14,16 or 18 French Foley catheter.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02198833
Study Brief:
Protocol Section:
NCT02198833