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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07384559

Enrollment

Registered

2026-02-03

Start date

2026-03-02

Completion date

2026-07-31

Last updated

2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retention, Urinary

Brief 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.

Interventions

OTHERMRI scan

MRI scan of SCI and healthy male/female subjects during catheterization

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

To obtain usable MRI 3D images of lower urinary tract and surroundings during voiding (healthy subjects) and during bladder emptying with IC (healthy subjects and SCI subjects).

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N).	up to 28 days

Contacts

CONTACTKaren Grigo, PhD

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

PRINCIPAL_INVESTIGATORWalter Wigger-Alberti, M.D.

Eurofins bioskin GmbH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026