Tolerance, Use and Performance of the PEASY Urine Collection Device in Hospitalized Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes
About this trial
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
Qualifiers
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.).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Daily use of the PEASY urine collection device for 5 days
- Daily collection of patient feedback using a visual analog scale (0-100)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov