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

NCT07028996 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2027-01-15
Completion
2027-01-15

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07028996 on ClinicalTrials.gov