[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"medical-device-discomfort\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:medical-device-discomfort":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100595172","tolerance-use-and-performance-of-the-peasy-urine-collection-device-in-hospitalized-patients-100595172",false,"NCT07028996","Tolerance, Use and Performance of the PEASY Urine Collection Device in Hospitalized Patients","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","TUPELO","Inclusion Criteria:\n\n* Patients requiring non-invasive urine collection.\n* Incontinent patient for whom the use of a penile pouch to control leakage has been suggested by the care team.\n* Uncircumcised patient.\n* Patient with no physical anomaly preventing complete unhooding (phimosis, micropenis, penile invagination, etc.).\n* Patient with no apparent irritation or infection of the glans (mycosis, herpetic lesion, etc.).\n* Patient is conscious and able to answer simple questions.\n* Patient has given free and informed consent.\n* Patient has signed the consent form.\n* Patient affiliated or beneficiary of a health insurance plan.\n\nExclusion Criteria:\n\n* Patient participating in another high-risk interventional study.\n* Patient in an exclusion period determined by another study.\n* Patient under court protection, guardianship or curatorship.\n* Patient unable to give consent.\n* Patient for whom it is impossible to give informed information.\n* Circumcised patients.","MALE","18 Years",{"count":20,"type":21},20,"ESTIMATED","OBSERVATIONAL","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.\n\nThere 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.",[25,26],"Urinary Incontinence","Medical Device Discomfort",[28,29,30],"Urinary incontinence","Penile clamp","Urinary sheath","RECRUITING","2026-03-10",{"date":34,"type":35},"2026-03-12","ACTUAL",{"date":37,"type":35},"2025-07-16",{"date":39,"type":21},"2027-01-15",{"name":41,"class":42},"Centre Hospitalier Universitaire de Nīmes","OTHER"]