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Not yet recruiting 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

No phase Interventional Retention, Urinary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI scan.
Who it may be relevant to
Registry conditions: Retention, Urinary. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07384559 · CP386

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗