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

Sponsor
Centre Hospitalier Universitaire de Nīmes
Study ID
NCT07028996
Status
Recruiting
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Conditions

  • Medical Device Discomfort
  • Urinary Incontinence

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daily use of the PEASY urine collection device for 5 days — DEVICE
    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.
  • Daily collection of patient feedback using a visual analog scale (0-100) — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jun 19, 2025
Start date
Jul 16, 2025
Status verified
Jun 2025
Primary completion
Jan 15, 2027
Completion
Jan 15, 2027

Study Design

Enrollment
20 participants (estimated)

Primary Outcome Measure

Daily measurement (at each change) from the patient's point of view. Pain in the glans [ Time Frame: Day 1 ]

Central Contacts

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