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

NCT07028996 | Recruiting

• 1 other identifier: IDIL
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Medical Device Discomfort

Keywords

Urinary incontinence; Penile clamp; Urinary sheath

Outcome Measures

Primary Outcomes (20)

• 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.

  Day 1

• 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.

  Day 1

• 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.

  Day 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.

  Day 2

• Daily measurement (at each change) from the patient's point of view. Pruritis/burning in the glans or foreskin

  Pruritis/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.

  Day 2

• 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.

  Day 2

• 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.

  Day 3

• Daily measurement (at each change) from the patient's point of view. Pruritis/burning in the glans or foreskin

  Pruritis/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.

  Day 3

• 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.

  Day 3

• 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.

  Day 4

• Daily measurement (at each change) from the patient's point of view. Pruritis/burning in the 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.

  Day 4

• 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.

  Day 4

• 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.

  Day 5

• Daily measurement (at each change) from the patient's point of view. Pruritis/burning in the 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.

  Day 5

• 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.

  Day 5

• Daily measurement rom the caregiver's point of view

  The following information will be recorded: appearance of erythema on the glans: Yes/No; appearance of erythema on the prepuce: Yes/No; patient's sensation of pain at the time of insertion: Yes/No; patient's sensation of pain at the time of removal: Yes/No

  Day 1

• Daily measurement rom the caregiver's point of view

  The following information will be recorded: appearance of erythema on the glans: Yes/No; appearance of erythema on the prepuce: Yes/No; patient's sensation of pain at the time of insertion: Yes/No; patient's sensation of pain at the time of removal: Yes/No

  Day 2

• Daily measurement rom the caregiver's point of view

  The following information will be recorded: appearance of erythema on the glans: Yes/No; appearance of erythema on the prepuce: Yes/No; patient's sensation of pain at the time of insertion: Yes/No; patient's sensation of pain at the time of removal: Yes/No

  Day 3

• Daily measurement rom the caregiver's point of view

  The following information will be recorded: appearance of erythema on the glans: Yes/No; appearance of erythema on the prepuce: Yes/No; patient's sensation of pain at the time of insertion: Yes/No; patient's sensation of pain at the time of removal: Yes/No

  Day 4

• Daily measurement rom the caregiver's point of view

  The following information will be recorded: appearance of erythema on the glans: Yes/No; appearance of erythema on the prepuce: Yes/No; patient's sensation of pain at the time of insertion: Yes/No; patient's sensation of pain at the time of removal: Yes/No

  Day 5

Secondary Outcomes (23)

• A. Performance of PEASY from the caregiver's point of view: Bladder weakness

  Day 1

• A. Performance of PEASY from the caregiver's point of view: Bladder weakness

  Day 2

• A. Performance of PEASY from the caregiver's point of view: Bladder weakness

  Day 3

• A. Performance of PEASY from the caregiver's point of view: Bladder weakness

  Day 4

• A. Performance of PEASY from the caregiver's point of view: Bladder weakness

  Day 5

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: People with penises
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient participating in another high-risk interventional 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Coralie LABARIAS

Nîmes, France

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cédric Le Guillou, Dr.

CONTACT

+33 6 24 33 51 82; cedric.leguillou@chu-nimes.fr

Anissa MEGZARI

CONTACT

0466684236; drc@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 19, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: March 12, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)