ClinicalTrials.gg
Not yet recruitingNCT07384559Updated Feb 3, 2026

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

An interventional study of MRI scan in Retention, Urinary, sponsored by Coloplast A/S. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Coloplast A/S · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Retention, Urinary

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03

In context

Urinary Retention

241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.

This study's planned enrollment of 20 is below the median of 90 across 187 interventional studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

Coloplast A/S is the lead sponsor of 150 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Has given written
  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

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 , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    MRI scan

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

    Other: MRI scan

Interventions

  • OtherMRI scan

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07384559
Lead sponsor
Coloplast A/S
Responsible party
Sponsor
First posted
Feb 3, 2026
Start date
Mar 2, 2026 (estimated)
Primary completion
Jul 31, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Feb 3, 2026

Study contacts

Karen Grigo, PhD
Contact
DEKAGR@coloplast.com
+49 17 28 49 34 17
Walter Wigger-Alberti, M.D.
principal investigator · Eurofins bioskin GmbH

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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