NCT05560594

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

August 2, 2022

Last Update Submit

October 17, 2022

Conditions

Urinary Function

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Intermittent catheter

OTHER

Coloplast SpeediCath CH12 male intermittent catheter

Device: Coloplast SpeediCath CH12 standard male intermittent catheter

Interventions

Coloplast SpeediCath CH12 standard male intermittent catheterDEVICE

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

Intermittent catheter

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy male adults
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Has given written informed consent
  • Be at least 18 years of age and have full legal capacity

You may not qualify if:

  • 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"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Study Officials

  • Per Bagi, PI

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

September 29, 2022

Study Start

February 27, 2022

Primary Completion

August 25, 2022

Study Completion

August 25, 2022

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations

DK(1)