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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT02835456
Eligibility Criteria:
Inclusion Criteria:
* Patient requires a chronic indwelling Foley catheter for at least 3 days.
* Catheters will not remain indwelling greater than 30 days at a time
* Patient is more than 18 years of age
* Patient is able to give informed consent
* Patient is able to attend follow-up sessions
Exclusion Criteria:
* Patient is less than 18 years of age
* Patient is pregnant
* Patient with a known allergy to silicone
* Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter
* Patient unable to accommodate the catheter
* Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated.
* Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period
* Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage)
* Patient is unable to feel and/or communicate their symptoms
* Informed consent is unable to be obtained
* Patient is unable or unwilling to comply with the study follow-up schedule
* Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis
* Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02835456
Study Brief:
Protocol Section:
NCT02835456