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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03522766
Date of registration: 01/05/2018
Prospective Registration: No
Primary sponsor: Coloplast A/S
Public title: Evaluation of Urine Samples and Their Relation to Urinary Tract Infection
Scientific title: Evaluation of Urine Samples and Their Relation to Urinary Tract Infection
Date of first enrolment: March 19, 2018
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03522766
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Denmark
Contacts
Name:     Lene F Nielsen, PhD
Address: 
Telephone:
Email:
Affiliation:  Coloplast A/S
Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Urinary Tract Infections
Intervention(s)
Other: urine sample
Primary Outcome(s)
Type of bacteria present in the urine [Time Frame: 1 year]
Secondary Outcome(s)
Secondary ID(s)
CP287
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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