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

NCT07384559 | Not Yet Recruiting

• 1 other identifier: CP386
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Retention, Urinary

Outcome Measures

Primary Outcomes (1)

• Is the quality of the 3D MRI images performed at Visit 2 sufficient for further use/analysis? (Y/N).

  up to 28 days

Study Arms (1)

MRI scan

OTHER

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

Other: MRI scan

Interventions

MRI scan OTHER

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

MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 a body weight that exceeds the maximum of 150kg max

Sponsors & Collaborators

• Coloplast A/S: lead

MeSH Terms

Conditions

Urinary Retention

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Walter Wigger-Alberti, M.D.

  Eurofins bioskin GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Grigo, PhD

CONTACT

+49 17 28 49 34 17; DEKAGR@coloplast.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To obtain usable MRI 3D images of lower urinary tract and surroundings during voiding (healthy subjects) and during bladder emptying with IC (healthy subjects and SCI subjects).

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 3, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01