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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new urine collection device called PEASY, designed for men who have trouble controlling their urine (urinary incontinence). Unlike current devices like pads or penile sheaths, which can cause discomfort, skin irritation, and problems staying in place, the PEASY device aims to be more comfortable and leak-proof. It fits over the tip of the penis and is held gently in place without sticky adhesives, using the foreskin instead. The study is being done to see how well this new device works and how easy it is for patients and caregivers to use.

Men who might join the study are those who need a non-invasive way to collect urine, have been recommended to try a penile pouch, are not circumcised, and don’t have any physical conditions affecting the penis or infections. Participants need to be alert and able to answer simple questions, and they must agree to join by signing a consent form. The trial is not yet recruiting, but when it starts, patients can expect to use the PEASY device while hospital staff observe how well it fits, how comfortable it is, and whether it helps prevent leaks and irritation compared to current options. This study focuses only on men who meet these specific health and consent requirements.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.