NCT07028996 Tolerance, Use and Performance of the PEASY Urine Collection Device in Hospitalized Patients
| NCT ID | NCT07028996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Urinary Incontinence |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-07-16 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07028996 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07028996 currently recruiting?
Yes, NCT07028996 is actively recruiting participants. Contact the research team at cedric.leguillou@chu-nimes.fr for enrollment information.
Where is the NCT07028996 trial being conducted?
This trial is being conducted at Nîmes, France.
Who is sponsoring the NCT07028996 clinical trial?
NCT07028996 is sponsored by Centre Hospitalier Universitaire de Nīmes. The trial plans to enroll 20 participants.