Investigate Bladder and Prostate During Emptying With Intermittent Catheter

Explorative Study Investigating the Urinary Bladder and Prostate During Intermittent Catheterization in Healthy Male Adults by Use of MR-scanning.

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

Study Overview

• Status: Completed
• Conditions: Urinary Function
• Intervention / Treatment: Device: Coloplast SpeediCath CH12 standard male intermittent catheter

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intermittent catheter; Coloplast SpeediCath CH12 male intermittent catheter	Device: Coloplast SpeediCath CH12 standard male intermittent catheter; Drainage of the bladder through the urethra when using the SpeediCath standard male intermittent catheter.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Per Bagi, PI, Per.bagi@regionh.dk /+45 35 45 83 10

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2022
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CP336

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No