[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527440":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":28,"locations":36,"responsibleParty":68,"collaborators":11,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":11,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":11,"overallStatus":55,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"A.O.U. Città della Salute e della Scienza","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group with drainage","EXPERIMENTAL",null,[13],"Device: External scrotal drainage",{"label":15,"type":16,"description":11,"interventionNames":11},"Group without drainage","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DEVICE","External scrotal drainage","Application of external scrotal drainage during three-component penile prosthesis placement",[9],[24],{"name":25,"affiliation":26,"role":27},"Falcone Mr Marco, Physician","Urology","PRINCIPAL_INVESTIGATOR",[29,33],{"name":25,"role":30,"phone":31,"phoneExt":11,"email":32},"CONTACT","0116336594","marco.falcone@unito.it",{"name":34,"role":30,"phone":31,"phoneExt":11,"email":35},"Preto Mr Mirko, Physician","mirko.preto@unito.it",[37,53],{"facility":38,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"SCDU Urologia","NOT_YET_RECRUITING","Torino","10126","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],11.99138,44.88856,{"lat":48,"lon":47},[51,52],{"name":25,"role":30,"phone":31,"phoneExt":11,"email":32},{"name":34,"role":30,"phone":31,"phoneExt":11,"email":35},{"facility":54,"status":55,"city":56,"state":56,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"A.O.U. Città della Salute e della Scienza di Torino","RECRUITING","Turin",{"type":45,"coordinates":58},[59,60],7.68682,45.07049,{"lat":60,"lon":59},[63,66],{"name":64,"role":30,"phone":65,"phoneExt":11,"email":35},"Mirko M Preto, MD, PhD","+39 0116335530",{"name":67,"role":30,"phone":65,"phoneExt":11,"email":32},"Marco M Falcone, MD, PhD",{"type":27,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Mirko Preto","Principal Investigator","100527440","risks-and-benefits-of-scrotal-drainage-in-penile-prosthesis-implant-100527440",false,"NCT06147791","Risks and Benefits of Scrotal Drainage in Penile Prosthesis Implant","Risks and Benefits of Using External Scrotal Drainage in Three-piece Penile Prosthesis Implant: a Prospective Randomized Study","Inclusion Criteria:\n\n* Written informed consent signed voluntarily according to the rules of good clinical practice (Declaration of Helsinki) and national regulations (Appendix B).\n* Genetically male patient.\n* Age ≥ 18 years.\n* Patient suffering from ED of variable and\u002For multifactorial etiology.\n* Patient suffering from ED not responsive to iPDE-5.\n* Patient suffering from unresponsive or non-tolerant ED\n\nExclusion Criteria:\n\n* Absence of signed written informed consent (Appendix B).\n* Age \\\u003C18 years.\n* Genetically female patients.\n* Patient with active peno-scrotal infection.\n* Patient with active systemic infection.\n* Immunosuppressed patient.\n* Patient with haematological pathologies that may cause an increased risk of bleeding.\n* Patients suffering from Peyronie's Disease who must undergo simultaneous plaque surgery.\n* Any condition or situation that, in the opinion of the investigator, places the patient at significant risk, may confound the results of the study, or significantly interfere with the patient's participation in the study.\n* The patient declares that it will be impossible for him to participate in follow-up consultations.","MALE","18 Years","90 Years",{"count":82,"type":83},50,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goal of this prospective randomized study is to demonstrate if the use of an external scrotal drainage in penile prosthetic surgery can reduce the risk of post-operative complications without increase the risk of infections.",[89],"Erectile Dysfunction","2025-01-22",{"date":92,"type":93},"2025-01-24","ACTUAL",{"date":95,"type":93},"2023-10-01",{"date":97,"type":83},"2033-10-01",{"name":5,"class":6},2]