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

March 10, 2026 updated by: Centre Hospitalier Universitaire de Nīmes

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Daily measurement rom the caregiver's point of view
Time Frame: Day 1
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
Time Frame: Day 2
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
Time Frame: Day 3
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
Time Frame: Day 4
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
Time Frame: Day 5
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
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 1
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
Time Frame: Day 2
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
Time Frame: Day 2
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
Time Frame: Day 2
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
Time Frame: Day 3
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
Time Frame: Day 3
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
Time Frame: Day 3
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
Time Frame: Day 4
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
Time Frame: Day 4
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
Time Frame: Day 4
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
Time Frame: Day 5
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
Time Frame: Day 5
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
Time Frame: Day 5
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time Frame: Day 1
YES/NO
Day 1
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time Frame: Day 2
YES/NO
Day 2
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time Frame: Day 3
YES/NO
Day 3
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time Frame: Day 4
YES/NO
Day 4
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time Frame: Day 5
YES/NO
Day 5
B. Performance of PEASY from the caregiver's point of view: facility of application
Time Frame: Day 1
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
Time Frame: Day 2
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
Time Frame: Day 3
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
Time Frame: Day 4
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
Time Frame: Day 5
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
Time Frame: Day 1
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
Time Frame: Day 2
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
Time Frame: Day 3
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
Time Frame: Day 4
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
Time Frame: Day 5
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 Frame: Random measurements over 5 days
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
Time Frame: Day 5
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
Time Frame: Day 5

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
Time Frame: Day 5
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
Time Frame: Day 5
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.
Time Frame: Day 5
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
Time Frame: Day 5
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
Time Frame: Day 5
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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