[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100278211":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":45,"centralContacts":50,"locations":57,"responsibleParty":73,"collaborators":10,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":10,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":87,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Fundación Instituto Valenciano de Oncología","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Artificial urinary sphincter AMS-800®",null,"Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AMS-800®",[13],"Procedure: AMS-800",{"label":15,"type":10,"description":16,"interventionNames":17},"AdVance\u002FAdvanceXP®","Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AdVance\u002FAdvanceXP®",[18],"Procedure: ADVANCE\u002FADVANCEXP",{"label":20,"type":10,"description":21,"interventionNames":22},"VIRTUE®","Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with VIRTUE®",[23],"Procedure: VIRTUE",{"label":25,"type":10,"description":26,"interventionNames":27},"INVANCE®","Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with INVANCE®",[28],"Procedure: INVANCE",[30,35,39,42],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"PROCEDURE","AMS-800","Artificial urianry sphincter",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"ADVANCE\u002FADVANCEXP","Male sling",[15],{"type":31,"name":40,"description":37,"armGroupLabels":41,"otherNames":10},"VIRTUE",[20],{"type":31,"name":43,"description":37,"armGroupLabels":44,"otherNames":10},"INVANCE",[25],[46],{"name":47,"affiliation":48,"role":49},"Argimiro Collado, MD,PhD","Fundación IVO","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Argimiro Collado, MD, PhD","CONTACT","0034961114030","4030","argicollado@gmail.com",[58],{"facility":59,"status":60,"city":61,"state":10,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Argimiro Collado","RECRUITING","Valencia","46009","Spain","ES",{"type":66,"coordinates":67},"Point",[68,69],-0.37966,39.47391,{"lat":69,"lon":68},[72],{"name":47,"role":53,"phone":54,"phoneExt":10,"email":10},{"type":74,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100278211","fundacin-ivo-registry-for-patients-undergoing-sling-or-artificial-urinary-sphincter-after-prostate-cancer-treatment-100278211",false,"NCT02901392","Fundación IVO Registry for Patients Undergoing Sling or Artificial Urinary Sphincter After Prostate Cancer Treatment","Fundación Instituto Valenciano de Oncología Prospective Registry for Patients Undergoing Male Sling or Artificial Urinary Sphincter After Prostatectomy or Radiation Therapy for Prostate Cancer.","Inclusion Criteria:\n\n1. The subject has agreed to be treated with the male Incontinence surgery devices\n2. The subject is willing and able to give valid informed consent.\n3. The subject is \\> 18 years of age.\n4. The subject has confirmed stress urinary incontinence for at least 12 months after prostatectomy or radiotherapy.\n5. It has been confirmed the stress urinary incontinence with 24-Hour Pad Weight test\n6. Pre-operative urodynamic assessment and flexible cystoscopy were performed in all cases\n7. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.\n8. There are no surgical contraindications.\n\nExclusion Criteria:\n\n1. The subject has an active urinary tract infection or active skin infection in region of surgery\n2. The subject has serious bleeding disorders\n3. The subject has unstable bladder neck stricture disease\n4. The subject has Neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.\n5. The subject has Detrusor-external sphincter dyssynergia.\n6. The subject is unable or unwilling to sign the informed consent form (ICF)and\u002For comply with all follow-up requirements according to the study protocol\n7. The subject is likely to undergo radiation therapy within the next 6 months\n8. The subject has a history of connective tissue or autoimmune conditions.\n9. The subject has a compromised immune system.\n10. The subject has renal insufficiency, and upper and\u002For lower urinary tract relative obstruction.\n11. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials","MALE","18 Years",{"count":85,"type":86},400,"ESTIMATED","15 Years","OBSERVATIONAL","Stress urinary incontinence is a significant potential source of morbidity after radical prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary sphincter remains the preferred therapeutic option. However, this technique is not free from complications. In an attempt to avoid such complications, male sling has been suggested for use in patients with mild degrees of stress incontinence.",[91],"Urinary Incontinence, Stress",[93,94,95,96],"Male Urethral Slings","Artificial Urinary Sphincter","Prostatectomy","Radiotherapy","2018-07-31",{"date":99,"type":100},"2018-08-02","ACTUAL",{"date":102,"type":10},"2004-04",{"date":104,"type":86},"2031-04",{"name":5,"class":6},1]