Urine Research Biobank
Establishment of a Urine Research Biobank to Explore Basic Urine Characteristics From Adult Intermittent Catheter Users
Study Overview
Detailed Description
This is a prospective non-interventional, exploratory study designed to collect urine samples from adult users of IC with and without UTIs. No investigational device is being tested, and no changes to standard care are introduced.
All urine samples collected will be stored in the research biobank for no longer than 5 years after last patient out (LPO).The total duration for each subject will be approximately one year from V1 or until subject have 4 full urine sample collections. During this period, urine samples will be collected by the subject at home, picked up from their residence, and transported to the research site. Subjects are required to complete a questionnaire in connection with both UTI episodes- and the baseline sample collection.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mette Krogh
- Phone Number: +4549113245
- Email: dkmekr@coloplast.com
Study Locations
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Humlebæk, Denmark, 3050
- Recruiting
- Coloplast research facility
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Contact:
- Lene Feldskov Nielsen
- Phone Number: +4549111888
- Email: dklfn@coloplast.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Is able (assessed by investigator) and willing to adhere to study procedures during study duration.
- Has used Intermittent Catheterization (IC) as primary method for bladder emptying for at least a year at time of enrolment.
- Has had at least 2 but fewer than 6 self-reported or clinically confirmed Urinary tract Infections in the last year prior to inclusion
Exclusion Criteria:
- Is participating or plan to participate in any other clinical study with direct relation to the lower urinary tract
- Has previously participated in this study
- Is currently using prophylactic antibiotic
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Total bacterial count from the 1st urine sample collected the day that the subject experienced symptoms of a UTI and the mean total bacterial count based on up to 3 samples from corresponding baseline
Time Frame: 4 collections of UTI and Baseline urine samples or participation from enrollemnt and 1 year.
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4 collections of UTI and Baseline urine samples or participation from enrollemnt and 1 year.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CP388
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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