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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Daily measurement (at each change) from the patient's point of view. Pain in the glans
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Daily measurement (at each change) from the patient's point of view. Pain in the glans
时间窗: 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 glans or foreskin
时间窗: 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
时间窗: 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 (at each change) from the patient's point of view. Pruritis/burning in the glans or foreskin
时间窗: 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 rom the caregiver's point of view
时间窗: 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
Daily measurement (at each change) from the patient's point of view. Pain in the glans
时间窗: 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. Sensation of discomfort
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 rom the caregiver's point of view
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- A. Performance of PEASY from the caregiver's point of view: Bladder weakness(Day 5)
- B. Performance of PEASY from the caregiver's point of view: facility of application(Day 5)
- C. Performance of PEASY from the caregiver's point of view: facility of removal(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.(Random measurements over 5 days)
- E.Qualitative evaluation by the caregiver of the various steps involved in applying the PEASY device(Day 5)
- F. Usability of the PEASY device using the System Usability Scale questionnaire.(Day 5)
- G. Success rate (%) of the PEASY(Day 5)
- H. User satisfaction from patient's point of view(Day 5)
- H. User satisfaction from the caregiver's point of view(Day 5)
- H. Suggestions for improving the PEASY device(Day 5)
- Summative evaluation of fitness for use according to EN62366:2015(Day 5)
- 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 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)
- B. Performance of PEASY from the caregiver's point of view: facility of application(Day 1)
- B. Performance of PEASY from the caregiver's point of view: facility of application(Day 2)
- B. Performance of PEASY from the caregiver's point of view: facility of application(Day 3)
- B. Performance of PEASY from the caregiver's point of view: facility of application(Day 4)
- C. Performance of PEASY from the caregiver's point of view: facility of removal(Day 1)
- C. Performance of PEASY from the caregiver's point of view: facility of removal(Day 2)
- C. Performance of PEASY from the caregiver's point of view: facility of removal(Day 3)
- C. Performance of PEASY from the caregiver's point of view: facility of removal(Day 4)