PEASY urine collection device for uncircumcised 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

We will test whether the PEASY non‑adhesive device can comfortably collect urine without leaks for uncircumcised hospitalized patients who need non‑invasive urine collection.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Centre Hospitalier Universitaire de Nīmes (other)
• Locations: 1 site (Nîmes)
• Trial ID: NCT07028996 on ClinicalTrials.gov

What this trial studies

This is an observational evaluation of the PEASY device, a non‑adhesive urine collector positioned on the glans and held by the foreskin, in hospitalized uncircumcised patients who require non‑invasive urine collection. Participants use the device daily for up to five days while reporting comfort, ease of use, fixation, and any leakage on a visual analog scale (0–100). The study focuses on tolerance, handling by care staff, and device performance compared with known issues with penile sheaths such as irritation and fixation problems. Data will be collected daily and summarized to characterize usability and side effects.

Who should consider this trial

Good fit: Uncircumcised, conscious hospitalized patients who need non‑invasive urine collection, have no glans infection or anatomical barriers to unhooding, and can give informed consent are ideal candidates.

Not a fit: Circumcised patients, people with phimosis or other anatomical issues preventing unhooding, those with active glans infection or irritation, and patients unable to consent are not eligible and unlikely to benefit.

Why it matters

Potential benefit: If successful, PEASY could reduce penile irritation and leakage and make urine collection easier and less painful for uncircumcised hospitalized patients.

How similar studies have performed: Existing data on penile sheaths and clamps show frequent irritation, fixation and handling problems, and the PEASY device represents a novel design without large prior clinical evidence of superiority.

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.

Where this trial is running

Nîmes

• Coralie LABARIAS — Nîmes, France (RECRUITING)

Study contacts

• Study coordinator: Cédric Le Guillou, Dr.

Conditions: Urinary Incontinence, Medical Device Discomfort, Urinary incontinence, Penile clamp, Urinary sheath