Urine Research Biobank
Establishment of a Urine Research Biobank to Explore Basic Urine Characteristics From Adult Intermittent Catheter Users
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Mette Krogh
- Telefonnummer: +4549113245
- E-post: dkmekr@coloplast.com
Studiesteder
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Humlebæk, Danmark, 3050
- Rekruttering
- Coloplast research facility
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Ta kontakt med:
- Lene Feldskov Nielsen
- Telefonnummer: +4549111888
- E-post: dklfn@coloplast.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CP388
Legemiddel- og utstyrsinformasjon, studiedokumenter
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