Urinary IncontinenceTUPELONCT07028996
Tolerance, Use and Performance of the PEASY Urine Collection Device in Hospitalized Patients
An observational study of Urinary Incontinence and Medical Device Discomfort, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence, Medical Device Discomfort
- What is being tested?
- Daily use of the PEASY urine collection device for 5 days and Daily collection of patient feedback using a visual analog scale (0-100)
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2025to 26 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- Patient has given free and informed consent.
- Patient has signed the consent form.
- Patient affiliated or beneficiary of a health insurance plan.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Incontinence, Medical Device Discomfort
- Being tested
- Daily use of the PEASY urine collection device for 5 days, Daily collection of patient feedback using a visual analog scale (0-100)
- Keywords
- Urinary incontinence, Penile clamp, Urinary sheath
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily use of the PEASY urine collection device for 5 daysDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 5
Secondary outcomes (23)
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
YES/NO
Measured: Day 1
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
YES/NO
Measured: Day 2
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
YES/NO
Measured: Day 3
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
YES/NO
Measured: Day 4
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
YES/NO
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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
Measured: 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:
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 5
Summative evaluation of fitness for use according to EN62366:2015
- 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.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start16 Jul 2025
- Primary completion26 May 2026
- Study completion26 May 2026
Why it stopped: The early termination of the study was due to recruitment difficulties and not to any safety or tolerability concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028996
- Sponsor's protocol ID
- IDIL
- Acronym
- TUPELO
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07028996
- Acronym / sponsor ID
- TUPELO / IDIL
- Conditions
- Urinary Incontinence, Medical Device Discomfort
- Keywords
- Urinary incontinence, Penile clamp, Urinary sheath
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The early termination of the study was due to recruitment difficulties and not to any safety or tolerability concerns.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily use of the PEASY urine collection device for 5 daysThe 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. | Device | – |
| 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. | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
23 secondary outcomes
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time frame: Day 1
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time frame: Day 2
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time frame: Day 3
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time frame: Day 4
A. Performance of PEASY from the caregiver's point of view: Bladder weakness
Time frame: Day 5
B. Performance of PEASY from the caregiver's point of view: facility of application
Time frame: Day 1
B. Performance of PEASY from the caregiver's point of view: facility of application
Time frame: Day 2
B. Performance of PEASY from the caregiver's point of view: facility of application
Time frame: Day 3
B. Performance of PEASY from the caregiver's point of view: facility of application
Time frame: Day 4
B. Performance of PEASY from the caregiver's point of view: facility of application
Time frame: Day 5
C. Performance of PEASY from the caregiver's point of view: facility of removal
Time frame: Day 1
C. Performance of PEASY from the caregiver's point of view: facility of removal
Time frame: Day 2
C. Performance of PEASY from the caregiver's point of view: facility of removal
Time frame: Day 3
C. Performance of PEASY from the caregiver's point of view: facility of removal
Time frame: Day 4
C. Performance of PEASY from the caregiver's point of view: facility of removal
Time frame: 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
E.Qualitative evaluation by the caregiver of the various steps involved in applying the PEASY device
Time frame: Day 5
F. Usability of the PEASY device using the System Usability Scale questionnaire.
Time frame: Day 5
G. Success rate (%) of the PEASY
Time frame: Day 5
H. User satisfaction from patient's point of view
Time frame: Day 5
H. User satisfaction from the caregiver's point of view
Time frame: Day 5
H. Suggestions for improving the PEASY device
Time frame: Day 5
Summative evaluation of fitness for use according to EN62366:2015
Time frame: Day 5
Results and safety
The study was stopped early (reason given: The early termination of the study was due to recruitment difficulties and not to any safety or tolerability concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Medical Device Discomfort, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The early termination of the study was due to recruitment difficulties and not to any safety or tolerability concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily measurement (at each change) from the patient's point of view. Pain in the glans (time frame: Day 1). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.