Investigate Bladder and Prostate During Emptying With Intermittent Catheter

Not Applicable

Completed

• Conditions: Urinary Function
• Interventions: Device: Coloplast SpeediCath CH12 standard male intermittent catheter

• Registration Number: NCT05560594
• Lead Sponsor: Coloplast A/S

Brief Summary

Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.

Detailed Description

12 healthy male adults will be enrolled in the investigation. The study includes one study visit where MR-scans of the bladder and prostate will be performed during normal voiding as baseline measurement followed by measurements during emptying of the bladder with an intermittent catheter (SpeediCath CH12 standard male intermittent catheter).

Study Timeline

• Study Start: 2022-02-27
• Study First Submitted: 2022-08-02
• Primary Completion: 2022-08-25
• Study Completion: 2022-08-25
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Male
• Has given written informed consent
• Be at least 18 years of age and have full legal capacity

Exclusion Criteria

• Participate in any other clinical investigation
• Has symptoms of UTI (Investigator's judgement)
• Has known abnormalities and/or diseases in the bladder and/ or the lower urinary tract
• Has had previous disease or surgery in lower urinary tract
• Has any MR-scanning contraindication - according to "MR check list"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intermittent catheter	Coloplast SpeediCath CH12 standard male intermittent catheter	Coloplast SpeediCath CH12 male intermittent catheter

Primary Outcome Measures

Name	Time	Method
Bladder behavior	Within 1 year after termination	Evaluate bladder behavior when emptying the bladder with an intermittent catheter evaluated by performance of 3D and dynamic MRI
Bladder morphology	Within 1 year after termination	Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark