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NCT Number: NCT07384559

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • Has symptoms of UTI at times of inclusion, as judged by the investigator.
  • Has a body weight that exceeds the maximum of 150kg max

Treatment and study plan

MRI scan

Other

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Grigo, PhD

CONTACT

[email protected]

+49 17 28 49 34 17

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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