Investigate Bladder and Prostate During Emptying With Intermittent Catheter

Urinary Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05560594
• Other study ID #: CP336
• Status: Completed
• Phase: N/A
• Start date: February 27, 2022
• Est. completion date: August 25, 2022

Study information

• Verified date: October 2022
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Urinary Function

Intervention

Device:
• Coloplast SpeediCath CH12 standard male intermittent catheter
Drainage of the bladder through the urethra when using the SpeediCath standard male intermittent catheter.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder morphology	Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI	Within 1 year after termination
Primary	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