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NCT Number: NCT07769606

Urine Research Biobank

This is an non-interventional exploratory study collecting urine samples from adult intermittent catheter users with and without UTIs. No investigational device is tested, and subjects' standard care remains unchanged. Urine samples will be stored in a research biobank until completion of the project

Recruiting

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Key information

Conditions

UTI

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coloplast research facility

Humlebæk, 3050, Denmark

Location status: Recruiting

Location contact

Lene Feldskov Nielsen

CONTACT

[email protected]

+4549111888

About this study

This is a prospective non-interventional, exploratory study designed to collect urine samples from adult users of IC with and without UTIs. No investigational device is being tested, and no changes to standard care are introduced.

All urine samples collected will be stored in the research biobank for no longer than 5 years after last patient out (LPO).The total duration for each subject will be approximately one year from V1 or until subject have 4 full urine sample collections. During this period, urine samples will be collected by the subject at home, picked up from their residence, and transported to the research site. Subjects are required to complete a questionnaire in connection with both UTI episodes- and the baseline sample collection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has given written informed consent
  • Is at least 18 years old
  • Has full legal capacity
  • Is able (assessed by investigator) and willing to adhere to study procedures during study duration.
  • Has used Intermittent Catheterization (IC) as primary method for bladder emptying for at least a year at time of enrolment.
  • Has had at least 2 but fewer than 6 self-reported or clinically confirmed Urinary tract Infections in the last year prior to inclusion

Exclusion criteria

  • Is participating or plan to participate in any other clinical study with direct relation to the lower urinary tract
  • Has previously participated in this study
  • Is currently using prophylactic antibiotic

Treatment and study plan

urinesample collection

Other

Collection of urine samples during UTI episodes and Collection of urine samples during a symptom-free baseline period

Primary outcomes

  1. Total bacterial count from the 1st urine sample collected the day that the subject experienced symptoms of a UTI and the mean total bacterial count based on up to 3 samples from corresponding baseline

    Time frame: 4 collections of UTI and Baseline urine samples or participation from enrollemnt and 1 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Mette Krogh

CONTACT

[email protected]

+4549113245

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Establishment of a Urine Research Biobank to Explore Basic Urine Characteristics From Adult Intermittent Catheter Users

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

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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