Investigate Bladder and Prostate During Emptying With Intermittent Catheter

Coloplast

Status: Completed

Conditions: Urinary Function

Treatments: Device: Coloplast SpeediCath CH12 standard male intermittent catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05560594

CP336

Details and patient eligibility

About

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

Full 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).

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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"

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Intermittent catheter

Other group

Description:

Coloplast SpeediCath CH12 male intermittent catheter

Treatment:

Device: Coloplast SpeediCath CH12 standard male intermittent catheter