Sharklet Catheter Study

Randomized Controlled Trial for the Early Clinical Experience and Evaluation of the Radiance Clear Sharklet Silicone Foley Catheter

The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.

The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.

Inclusion Criteria:

• Patient requires a chronic indwelling Foley catheter for at least 14 days. Catheters will not remain indwelling greater than 30 days at a time
• Patient is more than 19 years of age
• Patient is able to give informed consent
• Patient is able to attend follow-up sessions

Exclusion Criteria:

• Patient is less than 19 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. Once the infection has been treated, the patient is eligible for study.
• 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