Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

Completed

• Conditions: Urinary Tract Infections

• Registration Number: NCT03522766
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-19
• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-11
• Primary Completion: 2019-09-23
• Study Completion: 2019-09-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type of bacteria present in the urine	1 year	The different bacteria isolated present in the urine will be identified

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark