[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624839":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":61,"collaborators":27,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":27,"maxAge":27,"enrollmentInfo":73,"targetDuration":27,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"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,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hospital J M Penna","RECRUITING","Buenos Aires","Argentina","AR",{"type":50,"coordinates":51},"Point",[52,53],-58.37723,-34.61315,{"lat":53,"lon":52},[56,59],{"name":38,"role":39,"phone":57,"phoneExt":27,"email":58},"549114911-5555","Ilesaenger@gmail.com",{"name":38,"role":60,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Ileana Sänger","Head of Gynecology, Department of Obstetrics and Gynecology","100624839","the-amper-study-evaluation-of-the-efficacy-of-human-amniotic-membrane-grafting-in-preventing-mesh-exposure-in-vaginal-reconstructive-surgery-using-polypropylene-mesh-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":74,"type":75},330,"ESTIMATED","INTERVENTIONAL",[78],"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",[81,82],"Pelvic Organ Prolapse Vaginal Surgery","Stress Urinary Incontinence in Women",[84,85],"amniotic membrane graft","polypropylene mesh","2026-06-15",{"date":88,"type":89},"2026-06-17","ACTUAL",{"date":91,"type":89},"2026-03-01",{"date":93,"type":75},"2028-12-31",{"name":5,"class":6},1]