[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620602":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":58,"collaborators":25,"id":61,"slug":25,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaginal mesh surgery","EXPERIMENTAL","Vaginal mesh surgery for apical prolapse",[13],"Procedure: Vaginal mesh surgery for apical prolapse",{"label":15,"type":16,"description":17,"interventionNames":18},"Robotic-assited abdominal sacrocolpopexy","ACTIVE_COMPARATOR","Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse",[19],"Procedure: Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Cirurgia com tela vaginal para prolapso apical.",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"Cirurgia robótica assistida por tela abdominal com dispositivo Upsylon (Boston Scientific - EUA) para prolapso apical vaginal.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Marcelo Hisano, MD PhD","CONTACT","551126618080","m.hisano@hc.fm.usp.br",[36],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital das Clinicas da Faculdade de Medicina de Sao Paulo","RECRUITING","São Paulo","05403000","Brazil",{"type":43,"coordinates":44},"Point",[45,46],-46.63611,-23.5475,{"lat":46,"lon":45},[49,51,53,56],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":50},"secretariauro.ichc@hc.fm.usp.br",{"name":52,"role":32,"phone":33,"phoneExt":25,"email":50},"Cristiano Mendes Gomes, MD Professor",{"name":54,"role":55,"phone":25,"phoneExt":25,"email":25},"Luccas Soares Laferreira, MD","SUB_INVESTIGATOR",{"name":31,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Marcelo Hisano","Principal Investigator","100620602",false,"NCT07359755","Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study","A Comparative Analysis of Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Genital Prolapse: a Prospective Randomized Non-inferiority Study.","Inclusion Criteria:\n\n* The study will include patients diagnosed with apical compartment genital prolapse of stage II or higher, who have an indication for surgical correction.\n\nExclusion Criteria:\n\n* The following exclusion criteria will apply: patients who are unable or unwilling to complete validated outcome assessment instruments; those requiring concomitant surgical procedures (e.g., hysterectomy or any other intervention that may alter pelvic floor anatomy);\n* individuals with a prior history of pelvic radiotherapy;\n* patients with congenital or acquired anomalies of the urogenital or gastrointestinal systems;\n* and those with medical conditions that constitute a contraindication to elective surgical intervention.","FEMALE","18 Years",{"count":70,"type":71},86,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this study is to compare vaginal mesh surgery with abdominal robotic-assisted mesh surgery for the treatment of genital prolapse in women. The main questions it seeks to answer are:\n\n* Is the objective cure rate for vaginal mesh surgery non-inferior to that of the abdominal approach?\n* Is the use of vaginal mesh as safe as abdominal mesh?",[77,78,79,80],"Pelvic Organ Prolapse (POP)","Pelvic Organ Prolapse Vaginal Surgery","Mesh Reinforcement","Vaginal Apex\u002FUterine Prolapse",[82,83,84,85,86,87],"Pelvic organ prolapse","Vaginal prolapse","Vaginal mesh","Robotic-assisted sacrocolpopexy","Sacrocolpopexy","Uterine prolapse","2026-01-15",{"date":90,"type":91},"2026-01-22","ACTUAL",{"date":93,"type":91},"2025-09-15",{"date":95,"type":71},"2030-06",{"name":5,"class":6},1]