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Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner

NCT07384559•Coloplast A/S

View on ClinicalTrials.gov

Summary

This is an exploratory study investigating morphological and physiological changes of the lower urinary tract and surrounding structures during IC use in individuals with SCI, and during normal voiding and IC use in healthy individuals.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Has given written informed consent
•2. Is at least 18 years old
•3. Has full legal capacity
•4. Is able (assessed by investigator) and willing to adhere to study procedures during study duration
•5. Is able (assessed by investigator) to remain seated in the MRI scanner for minimum 20 minutes\*
•6. Known with SCI for a minimum of 1 year\*
•7. Has used IC as primary bladder emptying method for at least 3 months\* \* Only for SCI subjects

Exclusion Criteria

•1. Is participating in any other clinical investigation during this investigation
•2. Has previously completed this investigation
•3. Has any known allergic or hypersensitive reactions to any device or its ingredients used in the investigation
•4. Is pregnant
•5. Has had surgical procedures performed in the lower urinary tract.
•6. Has active/recurrent bladder cancer
•7. Has experienced autonomic dysreflexia within the last 2 years
•8. Has any MRI-scanning contraindications, according to MR check list provided by the site (e.g. active implants like pacemaker, cochlear implant, event recorder, implanted insulin pump)
•9. Has symptoms of UTI at times of inclusion, as judged by the investigator.
•10. Has a body weight that exceeds the maximum of 150kg max

Key Dates

Start Date

March 2, 2026

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2026

Last Updated

February 3, 2026

Enrollment

ESTIMATED participants

Conditions

Retention, Urinary

Interventions

MRI scan

OTHER

Contacts

Karen Grigo, PhD

CONTACT

+49 17 28 49 34 17 DEKAGR@coloplast.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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