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OpenTrials
Completed

NCT Number: NCT05560594

Investigate Bladder and Prostate During Emptying With Intermittent Catheter

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

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Key information

Conditions

Urinary Function

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Coloplast SpeediCath CH12 standard male intermittent catheter

Device

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

Primary outcomes

  1. Bladder morphology

    Time frame: Within 1 year after termination

    Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI

  2. Bladder behavior

    Time frame: Within 1 year after termination

    Evaluate bladder behavior when emptying the bladder with an intermittent catheter evaluated by performance of 3D and dynamic MRI

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2022
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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