Urine Research Biobank

NCT07769606 | Recruiting

• 1 other identifier: CP388
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

UTI

Outcome Measures

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

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

Interventions

urinesample collection OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults using IC as their primary method for bladder emptying.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast research facility

Humlebæk, 3050, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples collected in the event of symptoms of UTI and baseline urine samples

Central Study Contacts

Mette Krogh

CONTACT

+4549113245; dkmekr@coloplast.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: August 14, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

DK (1)