Urine Research Biobank
Establishment of a Urine Research Biobank to Explore Basic Urine Characteristics From Adult Intermittent Catheter Users
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Mette Krogh
- Telefonnummer: +4549113245
- E-post: dkmekr@coloplast.com
Studieorter
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Humlebæk, Danmark, 3050
- Rekrytering
- Coloplast research facility
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Kontakt:
- Lene Feldskov Nielsen
- Telefonnummer: +4549111888
- E-post: dklfn@coloplast.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CP388
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