Urinary Function
Conditions
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).
Interventions
DEVICEColoplast SpeediCath CH12 standard male intermittent catheter
Drainage of the bladder through the urethra when using the SpeediCath standard male intermittent catheter.
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Explore the behavior of the urinary bladder and prostate during emptying the bladder with an intermittent catheter. By use of 3D scanning techniques and dynamic MRI, the objective is to investigate behavior of bladder emptying using an intermittent catheter compared to the voluntary bladder emptying.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bladder morphology | Within 1 year after termination | Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI |
| 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 |
Countries
Denmark
Outcome results
None listed