Investigate Bladder and Prostate During Emptying With Intermittent Catheter

NCT ID: NCT05560594

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-27
• Study Completion Date: 2022-08-25

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).

Conditions

Urinary Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intermittent catheter

Coloplast SpeediCath CH12 male intermittent catheter

Group Type: OTHER

Coloplast SpeediCath CH12 standard male intermittent catheter

Intervention Type: DEVICE

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

Interventions

Coloplast SpeediCath CH12 standard male intermittent catheter

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

Intervention Type: DEVICE

Eligibility Criteria

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"

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Bagi, PI

Role: PRINCIPAL_INVESTIGATOR

Per.bagi@regionh.dk /+45 35 45 83 10

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

CP336

Identifier Type: -

Identifier Source: org_study_id