RecruitingNot Applicable

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

France20 participantsStarted 2025-07-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Daily measurement (at each change) from the patient's point of view. Pain in the glans

Timeframe: Day 1

Daily measurement (at each change) from the patient's point of view. Pruritis/burning in glans or foreskin

Timeframe: Day 1

Daily measurement (at each change) from the patient's point of view. Sensation of discomfort

Timeframe: Day 1

Daily measurement (at each change) from the patient's point of view. Pain in the glans

Timeframe: Day 2

Daily measurement (at each change) from the patient's point of view. Pruritis/burning in the glans or foreskin

Timeframe: Day 2

Daily measurement (at each change) from the patient's point of view. Sensation of discomfort

Timeframe: Day 2

Daily measurement (at each change) from the patient's point of view. Pain in the glans

Timeframe: Day 3

Trial details

NCT IDNCT07028996

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01-15

Contact for this trial

Cédric Le Guillou, Dr.

+33 6 24 33 51 82 cedric.leguillou@chu-nimes.fr

View on ClinicalTrials.gov More Urinary Incontinence trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Daily measurement (at each change) from the patient's point of view. Pain in the glans

Timeframe: Day 1

Daily measurement (at each change) from the patient's point of view. Pruritis/burning in glans or foreskin

Timeframe: Day 1

Daily measurement (at each change) from the patient's point of view. Sensation of discomfort

Timeframe: Day 1

Daily measurement (at each change) from the patient's point of view. Pain in the glans

Timeframe: Day 2

Daily measurement (at each change) from the patient's point of view. Pruritis/burning in the glans or foreskin

Timeframe: Day 2

Daily measurement (at each change) from the patient's point of view. Sensation of discomfort

Timeframe: Day 2

Daily measurement (at each change) from the patient's point of view. Pain in the glans

Timeframe: Day 3