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

ConditionRetention, Urinary

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorColoplast A/S

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: MRI scanOther 1 intervention

Trial outcomes

Primary outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Coloplast A/S

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: