Investigate Bladder and Prostate During Emptying With Int... | NCT05560594

Studies
Investigate Bladder and Prostate During Emptying With Intermittent Catheter

NCT05560594

Sponsor

Coloplast A/S

Status

Completed

Last Update Posted

Oct 18, 2022Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Urinary Function

Interventions

Coloplast SpeediCath CH12 standard male intermittent catheter

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2022Actual

Primary Completion Date

Aug 25, 2022Actual

Completion Date

Aug 25, 2022Actual

First Submitted Date

Aug 2, 2022

First Submission Date that Met QC Criteria

Sep 26, 2022

First Posted Date

Sep 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2022

Last Update Posted Date

Oct 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intermittent catheter	Other	Coloplast SpeediCath CH12 male intermittent catheter	Device: Coloplast SpeediCath CH12 standard male intermittent catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coloplast SpeediCath CH12 standard male intermittent catheter	Device	Drainage of the bladder through the urethra when using the SpeediCath standard male intermittent catheter.	Intermittent catheter

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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"

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Healthy male adults

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per Bagi, PI	Per.bagi@regionh.dk /+45 35 45 83 10	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen			Denmark

Type	Date	Date Unknown
Release	Apr 7, 2025
Reset	Apr 24, 2025
Release	Mar 10, 2026
Reset	Mar 27, 2026

Submission Tracking

Estimated Results First Submitted Date

Apr 7, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 7, 2025			Apr 24, 2025
Mar 10, 2026

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.