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

Coloplast

Status: Begins enrollment this month

Conditions: Retention, Urinary

Treatments: Other: MRI scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT07384559

CP386

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Has given written informed consent
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

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 contraindications, 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

MRI scan

Other group

Description:

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

Treatment:

Other: MRI scan