RecruitingNCT07028996

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

Clinical Investigation Plan for Non-CE-marked Medical Device Without Marking Objective (Category 4.4) to Evaluate Tolerance, Use and Performance of a Urine Collection Device (PEASY), in Hospitalized Patients: First-in-man Pilot Study

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

20 participants

Start Date

Jul 16, 2025

Study Type

OBSERVATIONAL

Conditions

Urinary Incontinence Medical Device Discomfort

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria9

Patients requiring non-invasive urine collection.
Incontinent patient for whom the use of a penile pouch to control leakage has been suggested by the care team.
Uncircumcised patient.
Patient with no physical anomaly preventing complete unhooding (phimosis, micropenis, penile invagination, etc.).
Patient with no apparent irritation or infection of the glans (mycosis, herpetic lesion, etc.).
Patient is conscious and able to answer simple questions.
Patient has given free and informed consent.
Patient has signed the consent form.
Patient affiliated or beneficiary of a health insurance plan.

Exclusion Criteria6

Patient participating in another high-risk interventional study.
Patient in an exclusion period determined by another study.
Patient under court protection, guardianship or curatorship.
Patient unable to give consent.
Patient for whom it is impossible to give informed information.
Circumcised patients.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEDaily use of the PEASY urine collection device for 5 days

The PEASY device features a non-adhesive attachment system to the penis, unlike penile sheaths which are used for the same indications and whose attachment system is based on an adhesive system. Fixation of the PEASY device to the penis involves the use of a clamp on the foreskin. The clamp has a certain elasticity and has been developed to be atraumatic. The medical device comprises a glans cup which covers the urinary meatus. This cup therefore rests on the glans.

OTHERDaily collection of patient feedback using a visual analog scale (0-100)

Daily collection of patient feedback using a visual analog scale (0-100) and any suggestions for improving the device during an open interview at the end of the test period.