Evaluation of Urine Samples and Their Relation to Urinary Tract Infection
1 other identifier
observational
30
1 country
1
Brief Summary
The aim is to explore the human urine composition and its relation to urine tract infections
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2018
CompletedFirst Submitted
Initial submission to the registry
May 1, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2019
CompletedFebruary 5, 2020
January 1, 2020
1.5 years
May 1, 2018
January 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Type of bacteria present in the urine
The different bacteria isolated present in the urine will be identified
1 year
Study Arms (4)
Healthy volunteers with no urinary tract infections
people who don't experience urinary tract infections
Healthy volunteers with urinary tract infections
people who frequently experience urinary tract infections
Intermittent catheter users with neurogenic bladder
Intermittent catheter users with enlarged prostate
Interventions
The subjects are asked to give a maximum of 15 urine samples during the study
Eligibility Criteria
The study population consists of danish subjects and will consist of healthy volunteers as well as users of intermittent catheter (neurogenic bladder or enlarged prostate) with and without reoccurring urine tract infections.
You may qualify if:
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- 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
- For healthy volunteers without UTIs: No diag-nosed UTIs within the last year
- 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)
You may not qualify if:
- Be treated for urinary tract infection at time of enrolment
- May not take prophylactic treatment for urinary tract infections (antibiotics only)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Coloplast A/S
Humlebæk, 3050, Denmark
Biospecimen
urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lene F Nielsen, PhD
Coloplast A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2018
First Posted
May 11, 2018
Study Start
March 19, 2018
Primary Completion
September 23, 2019
Study Completion
September 23, 2019
Last Updated
February 5, 2020
Record last verified: 2020-01