[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación Instituto Valenciano de Oncología\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":19,"type":20},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.",[25],"Urinary Incontinence, Stress",[27,28,29,30],"Male Urethral Slings","Artificial Urinary Sphincter","Prostatectomy","Radiotherapy","RECRUITING","2018-07-31",{"date":34,"type":35},"2018-08-02","ACTUAL",{"date":37,"type":4},"2004-04",{"date":39,"type":20},"2031-04",{"name":41,"class":42},"Fundación Instituto Valenciano de Oncología","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":4,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100275442","spanish-urological-association-registry-of-patients-on-active-surveillance-100275442","NCT02865330","Spanish Urological Association Registry of Patients on Active Surveillance","Inclusion Criteria:\n\n1. PSA ≤ 10 ng \u002F mL; if prostate volume\\> 60 cc in transrectal, ultrasound includable with PSA\\>10 ng \u002F ml if PSAD \\\u003C0.20\n2. Local Stadium DRE; cT1c -cT2a\n3. Diagnosis of transrectal ultrasound guided biopsy minimum 10 cylinders\n4. Adenocarcinoma Prostate Gleason ≤ 6 (3 + 3) with local and central pathology review\n5. Maximum number of cylinders = 2 and none of them more than 5mm tumor or more than 50% of assignment\n6. \\\u003C80 years and greater expectancy to 10 years life (Charlson score)\n7. Patients able to understand active surveillance and sign the Informed Consent\n\nExclusion Criteria:\n\n1. Patient not be able to accept up with repeat biopsies\n2. Patient who does not want to sign the Informed Consent\n3. Hospital where the possibility of a biopsy confirmation at 6 months is not guaranteed under the terms of the inclusion criteria\n4. Patients with a history of ASAP (atypical small acinar proliferation or atypical microglands)\n5. Patients with treatment with inhibitors of 5-alpha-reductase as dutasteride (Avidart®) and finasteride (Proscar®) during the previous six months\n6. Patients who have undergone during the 6 months prior to any treatment symptomatic benign prostate hyperplasia, or any invasive urological procedure. It can be associated with an increase of PSA prior to phlebotomy. These therapies include, but they are not limited to, prostate biopsy, thermotherapy, microwave therapy, laser, urethral resection of the prostate, urethral catheterization and the lower genitourinary tract endoscopy.","80 Years",{"count":52,"type":20},946,"Description:\n\nMulticentre observational study, not randomized. Ambispective character (retro and prospective). Opened to any member of the Asociación Española de Urología (AEU), public and private medicine.\n\nJustification:\n\nActive surveillance is a strategy proposed to control the overtreatment derived from the opportunist screening in prostate cancer (PCa).\n\nIts development in our country is erratic and different in every Center. This database tries to include most of patients included in active surveillance in Spain with a few minimal inclusion criteria.\n\nMulticentre registry and follow up of the active surveillance in Spain.\n\nHypothesis:\n\nMortality cancer specific for PCa includible in active surveillance to 15 years is lower than 5 %.",[55],"Prostate Cancer",[57,58,59],"Intermediate Risk Prostate Cancer","Low Risk Prostate Cancer","Active Surveillance","2018-02-09",{"date":62,"type":35},"2018-02-12",{"date":64,"type":4},"2014-07",{"date":66,"type":20},"2034-07",{"name":41,"class":42},""]