Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
32 participants
INTERVENTIONAL
2016-08-31
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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
Radiance™ Clear Sharklet® Silicone Foley Catheter
Silicone Foley Catheter
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
Radiance™ Clear Sharklet® Silicone Foley Catheter
Silicone Foley Catheter
Interventions
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Radiance™ Clear Sharklet® Silicone Foley Catheter
Silicone Foley Catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Dirk Lange
Assistant Professor
Principal Investigators
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Dirk Lange, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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The Stone Centre, VGH/UBC
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H15-03435
Identifier Type: -
Identifier Source: org_study_id
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