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NCT03522766 Clinical Trial

Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

Urinary Tract Infections Clinical Trial

Official title:
Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03522766
Other study ID # CP287
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 19, 2018
Est. completion date September 23, 2019

Study information
Verified date January 2020
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim is to explore the human urine composition and its relation to urine tract infections

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 23, 2019
Est. primary completion date September 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Have given written informed consent

2. Be at least 18 years of age and have full legal capacity

3. For the 2 patient populations: Use intermittent catheter on a daily basis due to neurogenic bladder or enlarged prostate and have used IC for at least 2 months

4. For healthy volunteers without UTIs: No diag-nosed UTIs within the last year

5. For healthy volunteers with recurrent UTIs: 3 or more UTIs within the last year or 2 UTIs within the last 6 months (treated with antibiotics)

Exclusion Criteria:

1. Be treated for urinary tract infection at time of enrolment

2. May not take prophylactic treatment for urinary tract infections (antibiotics only)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• urine sample
The subjects are asked to give a maximum of 15 urine samples during the study

Locations
Country Name City State
Denmark Coloplast A/S Humlebæk

Sponsors (1)
Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Type of bacteria present in the urine The different bacteria isolated present in the urine will be identified 1 year
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