Recruiting
Phase 1

Sharklet Catheter

Sponsor:

University of British Columbia

Code:

NCT02669342

Conditions

Urinary Catheter

Urinary Tract Infections

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Radiance™ Clear Sharklet® Silicone Foley Catheter

Silicone Foley Catheter

Study Details

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.

Conditions

Urinary Catheter

Urinary Tract Infections

Study ID

NCT02669342

Start date

Aug, 2016

Status verified date

Apr, 2017

Completion date

Feb, 2019

Anticipated

Primary completion date

Feb, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Group A: Sharklet Catheter for 2 weeks first

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

active comparator: Group B: Sharklet Catheter for 4 weeks first

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

Interventions

Radiance™ Clear Sharklet® Silicone Foley Catheter

Silicone Foley Catheter

Primary outcome measure

  • Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL) [ Time Frame: 12 weeks ]
  • Number of symptomatic Urinary tract infections (UTIs) determined by urine culture [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Olga Arsovska

604-875-4111olga.arsovska@ubc.ca

Locations

The Stone Centre, VGH/UBC

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Olga Arsovska

604-875-4111olga.arsovska@ubc.ca

Principal Investigator:

Dirk Lange, PhD

More Information

Sponsor

University of British Columbia

Last update posted

Apr 6, 2017

Last verified

Apr, 2017

Keywords

  • Infection
  • Urinary Catheter
  • Sharklet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2017-04-06.