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Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

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ClinicalTrials.gov Identifier: NCT03522766
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

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

Condition or disease Intervention/treatment
Urinary Tract Infections Other: urine sample

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Urine Samples and Their Relation to Urinary Tract Infection
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : March 20, 2019
Estimated Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy volunteers with no urinary tract infections
people who don't experience urinary tract infections
Other: urine sample
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
Other: urine sample
The subjects are asked to give a maximum of 15 urine samples during the study

Intermittent catheter users with neurogenic bladder Other: urine sample
The subjects are asked to give a maximum of 15 urine samples during the study

Intermittent catheter users with enlarged prostate Other: urine sample
The subjects are asked to give a maximum of 15 urine samples during the study




Primary Outcome Measures :
  1. Type of bacteria present in the urine [ Time Frame: 1 year ]
    The different bacteria isolated present in the urine will be identified


Biospecimen Retention:   Samples Without DNA
urine samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522766


Contacts
Contact: Lotte S Jensen +45 49112732 dklst@coloplast.com

Locations
Denmark
Coloplast A/S Recruiting
Humlebæk, Denmark, 3050
Contact: Lotte S Jensen    +45 49112732    dklst@coloplast.com   
Sponsors and Collaborators
Coloplast A/S

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT03522766     History of Changes
Other Study ID Numbers: CP287
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases