[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624839":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":27,"id":63,"slug":27,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":27,"maxAge":27,"enrollmentInfo":71,"targetDuration":27,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Hospital General de Agudos J. M. Penna","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"With amniotic membrane","EXPERIMENTAL","Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh in whom a dehydrated human amniotic membrane patch was placed over the mesh or sling prior to vaginal closure.",[13,14,15],"Procedure: Sacrospinous Hysteropexy with Mesh","Procedure: Retropubic Mid-urethral Sling (Bottom-Up)","Procedure: Transobturator Mid-urethral Sling (Out-In)",{"label":17,"type":18,"description":19,"interventionNames":20},"without amniotic membrane, surgery alone","ACTIVE_COMPARATOR","Patients undergoing surgery for pelvic organ prolapse or stress urinary incontinence with polypropylene mesh without human amniotic membrane patch",[13,14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Sacrospinous Hysteropexy with Mesh","Sacrospinous Hysteropexy with polypropylene mesh",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Retropubic Mid-urethral Sling (Bottom-Up)","Retropubic mid-urethral sling (bottom-up approach) using polypropylene mesh for the treatment of stress urinary incontinence.",[9,17],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Transobturator Mid-urethral Sling (Out-In)","Transobturator mid-urethral sling (out-in) using polypropylene mesh for the treatment of stress urinary incontinence.",[9,17],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Ileana Sanger, MD","CONTACT","5491149113030","ilesaenger@me.com",[43],{"facility":44,"status":45,"city":46,"state":27,"zip":27,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hospital J M Penna","RECRUITING","Buenos Aires","Argentina",{"type":49,"coordinates":50},"Point",[51,52],-58.37723,-34.61315,{"lat":52,"lon":51},[55,58],{"name":38,"role":39,"phone":56,"phoneExt":27,"email":57},"549114911-5555","Ilesaenger@gmail.com",{"name":38,"role":59,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Ileana Sänger","Head of Gynecology, Department of Obstetrics and Gynecology","100624839",false,"NCT07414849","The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.","The Amper Study: Amniotic Membrane for the Prevention of Mesh Exposure in Vaginal Reconstructive Surgery","AMPER","Inclusion Criteria:\n\n* Pelvic organ prolapse (POP) stage II C or greater, defined as C ≥ +1, in women without prior hysterectomy and\u002For with a diagnosis of stress urinary incontinence seeking surgical treatment.\n* Ability to understand study information and provide written informed consent.\n* Availability for follow-up for a minimum of 12 months.\n\nExclusion Criteria:\n\n* Previous surgery with synthetic mesh (via vaginal or abdominal approach) for POP repair.\n* Known adverse reaction to synthetic meshes.\n* Unresolved or active chronic pelvic pain.\n* History of prior abdominal or pelvic radiation.\n* Contraindication to the planned surgical procedure.\n* Current pregnancy.","FEMALE",{"count":72,"type":73},330,"ESTIMATED","INTERVENTIONAL",[76],"NA","This study evaluates the efficacy of adding a human amniotic membrane graft to polypropylene mesh surgery for pelvic prolapse and stress urinary incontinence. The goal is to assess improvements in tissue integration and the reduction of surgical complications",[79,80],"Pelvic Organ Prolapse Vaginal Surgery","Stress Urinary Incontinence in Women",[82,83],"amniotic membrane graft","polypropylene mesh","2026-06-15",{"date":86,"type":87},"2026-06-17","ACTUAL",{"date":89,"type":87},"2026-03-01",{"date":91,"type":73},"2028-12-31",{"name":5,"class":6},1]