The early termination of the study was due to recruitment difficulties and not to any safety or tolerability concerns.
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
Sponsor study identifier
observational
11
1 country
1
Study Start
July 16, 2025
Actual (reported)Primary Completion
May 26, 2026
Actual (reported)Study Completion
May 26, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 26, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 3, 2025
Actual (reported)June 19, 2025
Actual (reported)July 16, 2025
Actual (reported)May 26, 2026
Actual (reported)May 26, 2026
Actual (reported)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
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
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) and any suggestions for improving the device during an open interview at the end of the test period.
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.
Coralie LABARIAS
Nîmes, France
11 participants (actual enrollment reported by the registry).
First Submitted
June 3, 2025
First Posted
June 19, 2025
Study Start
July 16, 2025
Actual (reported)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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 26, 2026
Actual (reported)Study Completion
May 26, 2026
Actual (reported)Last Updated
October 23, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: