Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

NCT ID: NCT03522766

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-19

Study Completion Date

2019-09-23

Brief Summary

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

Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers with no urinary tract infections

people who don't experience urinary tract infections

urine sample

Intervention Type OTHER

The subjects are asked to give a maximum of 15 urine samples during the study

Healthy volunteers with urinary tract infections

people who frequently experience urinary tract infections

urine sample

Intervention Type OTHER

The subjects are asked to give a maximum of 15 urine samples during the study

Intermittent catheter users with neurogenic bladder

urine sample

Intervention Type OTHER

The subjects are asked to give a maximum of 15 urine samples during the study

Intermittent catheter users with enlarged prostate

urine sample

Intervention Type OTHER

The subjects are asked to give a maximum of 15 urine samples during the study

Interventions

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urine sample

The subjects are asked to give a maximum of 15 urine samples during the study

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coloplast A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lene F Nielsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Coloplast A/S

Locations

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Coloplast A/S

Humlebæk, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CP287

Identifier Type: -

Identifier Source: org_study_id

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