Tolerance, Use and Performance of the PEASY Urine Collection Device in Hospitalized Patients
Recruiting now
Conditions studied: Urinary Incontinence, Medical Device Discomfort
In brief
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.
Key facts
- Study ID
- NCT07028996
- Run by
- Centre Hospitalier Universitaire de Nīmes
- People needed
- 20
- Starts
- 2025-07-16
- Expected to finish
- 2027-01-15
- Last updated by the study team
- 2026-03-12
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Coralie LABARIAS — Nîmes, France (enrolling)
Full record on ClinicalTrials.gov
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