Not Yet RecruitingNot Applicable

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

20 participantsStarted 2026-03-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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
✓. Is able (assessed by investigator) to remain seated in the MRI scanner for minimum 20 minutes\*
✓. Known with SCI for a minimum of 1 year\*
✓. Has used IC as primary bladder emptying method for at least 3 months\* \* Only for SCI subjects

Exclusion criteria

✕. Is participating in any other clinical investigation during this investigation
✕. Has previously completed this investigation
✕. Has any known allergic or hypersensitive reactions to any device or its ingredients used in the investigation
✕. Is pregnant
✕. Has had surgical procedures performed in the lower urinary tract.
✕. Has active/recurrent bladder cancer
✕. Has experienced autonomic dysreflexia within the last 2 years
✕. 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)

What they're measuring

Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N).

Timeframe: up to 28 days

Trial details

NCT IDNCT07384559

SponsorColoplast A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-31

Contact for this trial

Karen Grigo, PhD

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

View on ClinicalTrials.gov More Retention, Urinary trials