Actively Recruiting

Age: 18Years +
MALE
NCT07028996

Tolerance, Use and Performance of the PEASY Urine Collection Device in Hospitalized Patients

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-03-12

20

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

At present, 3 types of urine collection device can be distinguished: absorbent devices (diaper-type), penile clamps and penile collection sheaths. Both pads and penile sheaths are used depending on the department concerned, the clinical context and user preferences. A 2023 survey at Nîmes University Hospital showed that penis sleeves have undesirable side effects like fixation problems and pain on removal, and care assistants reported penile irritation caused by the penis sleeve. Caregivers also reported difficulties when handling and using penis sleeves. There is clearly a need for a better device.To overcome the disadvantages of penis covers, the PEASY project team at Nîmes University Hospital has developed a practical, non-invasive medical device for eliminating urine, positioned on the glans: the PEASY device. This device is held in place by a non-adhesive fastening system that involves the foreskin, to ensure leakage-free urine flow.

CONDITIONS

Official Title

Tolerance, Use and Performance of the PEASY Urine Collection Device in Hospitalized Patients

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients requiring non-invasive urine collection.
  • Incontinent patients recommended for penile pouch use by their care team.
  • Uncircumcised male patients.
  • Patients without physical abnormalities preventing full foreskin retraction (e.g., phimosis, micropenis, penile invagination).
  • Patients without visible irritation or infection of the glans (e.g., mycosis, herpetic lesion).
  • Patients who are conscious and able to answer simple questions.
  • Patients who have given free and informed consent and signed the consent form.
  • Patients affiliated with or beneficiaries of a health insurance plan.
Not Eligible

You will not qualify if you...

  • Patients participating in another high-risk interventional study.
  • Patients in an exclusion period determined by another study.
  • Patients under court protection, guardianship, or curatorship.
  • Patients unable to give consent.
  • Patients for whom informed information cannot be provided.
  • Circumcised patients.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Coralie LABARIAS

Nîmes, France

Actively Recruiting

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Research Team

C

Cédric Le Guillou, Dr.

CONTACT

A

Anissa MEGZARI

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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