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

Clinical Investigation Plan for Non-CE-marked Medical Device Without Marking Objective (Category 4.4) to Evaluate Tolerance, Use and Performance of a Urine Collection Device (PEASY), in Hospitalized Patients: First-in-man Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Medical Device Discomfort
• Intervention / Treatment: Device: Daily use of the PEASY urine collection device for 5 days; Other: Daily collection of patient feedback using a visual analog scale (0-100)

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Anissa MEGZARI; Phone Number: 0466684236; Email: drc@chu-nimes.fr
• Study Contact Backup: Name: Cédric Le Guillou, Dr.; Phone Number: +33 6 24 33 51 82; Email: cedric.leguillou@chu-nimes.fr

Study Locations

• France
  • Nîmes, France
    • Recruiting
    • Coralie LABARIAS
    • Contact: Coralie Labarias, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A. Performance of PEASY from the caregiver's point of view: Bladder weakness	YES/NO	Day 1
A. Performance of PEASY from the caregiver's point of view: Bladder weakness	YES/NO	Day 2
A. Performance of PEASY from the caregiver's point of view: Bladder weakness	YES/NO	Day 3
A. Performance of PEASY from the caregiver's point of view: Bladder weakness	YES/NO	Day 4
A. Performance of PEASY from the caregiver's point of view: Bladder weakness	YES/NO	Day 5
B. Performance of PEASY from the caregiver's point of view: facility of application	Question to caregiver: "How would you rate the application of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 1
B. Performance of PEASY from the caregiver's point of view: facility of application	Question to caregiver: "How would you rate the application of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 2
B. Performance of PEASY from the caregiver's point of view: facility of application	Question to caregiver: "How would you rate the application of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 3
B. Performance of PEASY from the caregiver's point of view: facility of application	Question to caregiver: "How would you rate the application of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 4
B. Performance of PEASY from the caregiver's point of view: facility of application	Question to caregiver: "How would you rate the application of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 5
C. Performance of PEASY from the caregiver's point of view: facility of removal	Question to caregiver: "How would you rate the removal of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 1
C. Performance of PEASY from the caregiver's point of view: facility of removal	Question to caregiver: "How would you rate the removal of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 2
C. Performance of PEASY from the caregiver's point of view: facility of removal	Question to caregiver: "How would you rate the removal of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 3
C. Performance of PEASY from the caregiver's point of view: facility of removal	Question to caregiver: "How would you rate the removal of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 4
C. Performance of PEASY from the caregiver's point of view: facility of removal	Question to caregiver: "How would you rate the removal of the PEASY device? Visual analog scale 0-10 in which 0 is "very difficult" and 10 is "very easy".	Day 5
D- Evaluation by the caregiver of the the time required for the complete procedure (insertion and removal) of the PEASY device. Measured randomly by the Clinical Research Assistant.	Time required to insert the device: from decapping to connection of the PEASY to the urine collection bag tubing. Time required to remove the device. Total times in seconds	Random measurements over 5 days
E.Qualitative evaluation by the caregiver of the various steps involved in applying the PEASY device	Questions to caregiver: "How do you rate each stage of using the PEASY device ? decapping, cup placement, recapping, PEASY device attachment, tubing connection. VAS 0-10 where 0 is "very difficult" and 10 is "very easy" for each step:	Day 5
G. Success rate (%) of the PEASY	Success = the PEASY could be worn by the patient for 5 days. Description of the circumstances in the event of failure of the PEASY (device more in contact with the glans; device torn off; device under pressure with collection of urine at the foreskin; rejection by the patient; etc.). Success will be recorded as YES/NO: success = PEASY could be worn by patient for 5 days. Failure = use of penile sleeve and description of circumstances in case of failure.	Day 5
H. Suggestions for improving the PEASY device	Free collection of suggestions for improving the device by the patient and caregiver during an interview with the hospital CRA.	Day 5
Summative evaluation of fitness for use according to EN62366:2015	I. Five randomly-selected volunteer caregivers will be questioned on Day 5 about the PEASY device's suitability for use, using a summative suitability-for-use assessment questionnaire in accordance with standard EN62366:2015.	Day 5
F. Usability of the PEASY device using the System Usability Scale questionnaire.	The system usability scale is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. Usability, as defined by the ISO standard ISO 9241 Part 11, can be measured only by taking into account the context of the system's use: i.e., who is using the system, what they are using it for, and the environment they are using it in. Measurements of usability have different aspects: effectiveness (can users successfully achieve their objectives) efficiency (how much effort and resources are expended to achieve those objectives) satisfaction (was the experience satisfactory). Measures of effectiveness and efficiency are context-specific. The System Usability Scale generally provides a high-level subjective view of usability and is often used to compare it between systems. It yields a single score on a scale of 0-100 in which 0 = completely unusable and 100 = extremely usable.	Day 5
H. User satisfaction from patient's point of view	User satisfaction with the PEASY device evaluated according to a visual analog scale of 0-100 in which 0 = completely dissatisfied and 100 = extremely satisfied.	Day 5
H. User satisfaction from the caregiver's point of view	User satisfaction with the PEASY device evaluated according to a visual analog scale of 0-100 in which 0 = completely dissatisfied and 100 = extremely satisfied.	Day 5

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: June 3, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Urinary incontinence; Penile clamp; Urinary sheath
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence
• Other Study ID Numbers: IDIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No