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OpenTrials
Completed

NCT Number: NCT03522766

Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

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

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Be treated for urinary tract infection at time of enrolment
  • May not take prophylactic treatment for urinary tract infections (antibiotics only)

Treatment and study plan

Urine sample

Other

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

Primary outcomes

  1. Type of bacteria present in the urine

    Time frame: 1 year

    The different bacteria isolated present in the urine will be identified

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 11, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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