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

January 29, 2026 updated by: Coloplast A/S
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRI scan
MRI scan of SCI and healthy male/female subjects during catheterization
Other: MRI scan
MRI scan of SCI and healthy male/female subjects during catheterization

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Walter Wigger-Alberti, M.D., Eurofins bioskin GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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