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

NCT ID: NCT07028996

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2026-07-31

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.

Detailed Description

The problem of urine collection arises not only in incontinent patients, but also in continent patients who are unable to collect urine "actively". At present, three types of urine collection device can be distinguished: absorbent devices (diaper-type), penile clamps and penile collection sheaths. In the hospital, both pads and penile sheaths are used according to the department concerned, the patient's clinical context and user preferences. For example, 30,000 penis covers were used in 10 departments at the CHU de Nîmes in 2022.

However, a survey carried out at the CHU de Nîmes in 2023 showed that penis sleeves have undesirable side effects: 67% of care assistants reported fixation problems and pain on removal; 52% of care assistants reported penile irritation following use of the penis sleeve.

The survey also showed that the use of penis sleeves is not without its drawbacks: 76% of caregivers reported difficulties when handling and using penis sleeves.

There is a clear need for a device that i) reduces the irritation associated with penis sleeves, ii) is easy to insert and remove, and iii) guarantees no leakage.

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, which is positioned on the glans penis: 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.

To date, the hospital disposes of have a pre-production device which has never been tested on humans under real-life conditions. Before going any further with its development, all questions relating to its tolerance, usability and expected performance need to be addressed.

This is the aim of this pilot study, the results of which will enable the investigators to improve the device with a view to obtaining a finished product, or to discontinue its development.

Conditions

Urinary Incontinence; Medical Device Discomfort

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Daily use of the PEASY urine collection device for 5 days

The 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.

Intervention Type: DEVICE

Daily collection of patient feedback using a visual analog scale (0-100)

Daily 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Cédric Le Guillou, Dr.

Role: CONTACT

cedric.leguillou@chu-nimes.fr

+33 6 24 33 51 82

Anissa MEGZARI

Role: CONTACT

drc@chu-nimes.fr

0466684236

Other Identifiers

IDIL

Identifier Type: -

Identifier Source: org_study_id