Sharklet Catheter Study

University of British Columbia

Status and phase: Unknown; Phase 1

Conditions: Urinary Tract Infections; Urinary Catheter

Treatments: Device: Radiance™ Clear Sharklet® Silicone Foley Catheter; Device: Silicone Foley Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02669342

H15-03435

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Group A: Sharklet Catheter for 2 weeks first

Active Comparator group

Description:

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

Treatment:

Device: Silicone Foley Catheter

Device: Radiance™ Clear Sharklet® Silicone Foley Catheter

Group B: Sharklet Catheter for 4 weeks first

Active Comparator group

Description:

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

Treatment:

Device: Silicone Foley Catheter

Device: Radiance™ Clear Sharklet® Silicone Foley Catheter