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
This trial does not accept healthy volunteersQualifiers
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 population
For the purposes of the study, 20 incontinent patients for whom the use of a penile pouch to control leakage has been suggested by the care team, will be recruited from the active file of patients hospitalized in the Geriatric Medicine department of the CHU de Nîmes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Daily use of the PEASY urine collection device for 5 days
DeviceThe PEASY device features a non-adhesive attachment system to the penis, unlike penile sheaths which are used for the same indications and whose attachment system is based on an adhesive system. Fixation of the PEASY device to the penis involves the use of a clamp on the foreskin. The clamp has a certain elasticity and has been developed to be atraumatic. The medical device comprises a glans cup which covers the urinary meatus. This cup therefore rests on the glans.
Daily collection of patient feedback using a visual analog scale (0-100)
Other interventionDaily collection of patient feedback using a visual analog scale (0-100) and any suggestions for improving the device during an open interview at the end of the test period.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Daily measurement (at each change) from the patient's point of view. Pain in the glans
Pain in the glans will be recorded on a 0-100 visual analog scale in which 0 = no pain and 100 = worst possible pain.
Time frame
Day 12
Daily measurement (at each change) from the patient's point of view. Pruritis/burning in glans or foreskin
Pruritus/burning in the glans or foreskin will be recorded on a 0-100 visual analog scale in which 0 = no pruritis/burning and 100 = worst possible pruritis/burning.
Time frame
Day 13
Daily measurement (at each change) from the patient's point of view. Sensation of discomfort
Sensation of discomfort will be recorded on a 0-100 visual analog scale in which 0 = no discomfort and 100 = worst possible discomfort.
Time frame
Day 14
Daily measurement (at each change) from the patient's point of view. Pain in the glans
Pain in the glans will be recorded on a 0-100 visual analog scale in which 0 = no pain and 100 = worst possible pain.
Time frame
Day 2Secondary outcomes
1
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
YES/NO
Time frame
Day 12
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
YES/NO
Time frame
Day 23
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
YES/NO
Time frame
Day 34
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
YES/NO
Time frame
Day 4Sponsors and contacts
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Source ClinicalTrials.gov