Investigate Bladder and Prostate During Emptying With Intermittent Catheter

Coloplast A/S12 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Urinary Function

Interventions

Coloplast SpeediCath CH12 standard male intermittent catheterDEVICE

Drainage of the bladder through the urethra when using the SpeediCath standard male intermittent catheter.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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"

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Bladder morphology

Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI

Time frame: 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

Time frame: Within 1 year after termination

Data from ClinicalTrials.gov

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