Sharklet Catheter Study

Phase 1

Interventions: Device: Radiance™ Clear Sharklet® Silicone Foley Catheter
Device: Silicone Foley Catheter

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group B: Sharklet Catheter for 4 weeks first	Silicone Foley Catheter	Arm B will have catheters inserted according to the schedule below: 1. Sharklet catheter inserted for 4 weeks 2. Standard catheter inserted for 4 weeks 3. Sharklet catheter inserted for 2 weeks 4. Standard catheter inserted for 2 weeks
Group A: Sharklet Catheter for 2 weeks first	Radiance™ Clear Sharklet® Silicone Foley Catheter	Arm A will have catheters inserted according to the schedule below: 1. Sharklet catheter inserted for 2 weeks 2. Standard catheter inserted for 2 weeks 3. Sharklet catheter inserted for 4 weeks 4. Standard catheter inserted for 4 weeks
Group B: Sharklet Catheter for 4 weeks first	Radiance™ Clear Sharklet® Silicone Foley Catheter	Arm B will have catheters inserted according to the schedule below: 1. Sharklet catheter inserted for 4 weeks 2. Standard catheter inserted for 4 weeks 3. Sharklet catheter inserted for 2 weeks 4. Standard catheter inserted for 2 weeks
Group A: Sharklet Catheter for 2 weeks first	Silicone Foley Catheter	Arm A will have catheters inserted according to the schedule below: 1. Sharklet catheter inserted for 2 weeks 2. Standard catheter inserted for 2 weeks 3. Sharklet catheter inserted for 4 weeks 4. Standard catheter inserted for 4 weeks

Primary Outcome Measures

Name	Time	Method
Number of symptomatic Urinary tract infections (UTIs) determined by urine culture	12 weeks	Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.
Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)	12 weeks	Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.

Secondary Outcome Measures

Name	Time	Method
Delay to symptomatic CA-SUTI	12 weeks	Delay to symptomatic catheter-associated symptomatic urinary tract infection (CA-SUTI)
Incidence of bacteria	12 weeks	Incidence of bacteremia following CA-SUTI
Incidence of Crustation	12 weeks	Incidence of catheter obstruction/encrustation requiring removal
Incidence of Discomfort	12 weeks	Incidence of significant discomfort/pain requiring removal
Surface analysis of the type of bacteria found on each catheter	12 weeks	Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of bacterial colonization
Surface analysis of the amount of encrustation	12 weeks	Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of encrustation
Surface analysis of the biofilm formation	12 weeks	Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of biofilm formation

Locations (1): The Stone Centre, VGH/UBC
🇨🇦
Vancouver, British Columbia, Canada