[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pelvic-floor-prolapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pelvic-floor-prolapse":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100631180","safety-and-performance-of-a-pelvic-floor-mesh-implant-for-laparoscopic-sacrocolpopexy-progynious-100631180",false,"NCT07497321","Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)","ProGYNious","Inclusion Criteria:\n\n* Subject is a candidate for surgical repair of pelvic organ prolapse by ProGYNious implant according to the indication of the product under evaluation\n* Symptomatic pelvic organ prolapse with POP-Q \\>= 2\n* Age \\>18 years and ≤ 80years\n* Subject is willing and able to cooperate with follow-up examinations\n* Subject has been informed of the study procedures and the treatment and has signed an informed consent form\n\nExclusion Criteria:\n\n* previous or concurrent cancer which may affect the successful treament with laparoscopic mesh\n* known or suspected hypersensitivity to ProGYNious mesh or a component of ProGYNious mesh (Polypropylene)\n* known severe osteoporosis\n* pregnancy, suspected pregnancy and breastfeeding\n* bleeding of unknown cause in the genital area\n* previously irradiated patients in the pelvic area\n* drug or medication abuse, medical, psychological or social circumstances that could affect the patient's participation in the study or the evaluation of the study results\n* Any previous interventions with surgical mesh for pelvic organ prolapse and\u002For urinary incontinence\n* Unable to understand study requirements or is unable to comply with follow-up schedule\n* Contraindicated according to the instruction for use of the device\n* patients with an increased risk of infection or impaired wound healing (e.g. Diabetes mellitus with HbA1c \\>10, systemic autoimmune diseases, etc.)\n* concomitant Sling\u002FTVT procedure\n* life expectancy lower than follow-up period (e.g. ASA 4)\n* non-symptomatic pelvic organ prolapse\n* chronic pain syndrome\n* chronic respiratory disease (e.g. COPD, chronic cough)","FEMALE","18 Years","80 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation. The primary objective is to verify the treatment outcome and success of the ProGYNious mesh implant in pelvic organ prolapse repair. The secondary objective is to confirm the safety, risks, complications and quality of life of ProGYNious as an implant for pelvic organ prolapse repair.",[27,28,29,30,31,32,33,34],"Pelvic Organ Prolapse (POP)","Synthetic Mesh","Laparoscopic Surgery","Gynecologic Laparoscopic Surgery","Sacrocolpopexy","Pelvic Floor Prolapse","Pelvic Floor","Implant",[14,36,37,38,39,40],"A.M.I.","AMI","Agency for Medical Innovation","Y Mesh","Progyn","NOT_YET_RECRUITING","2026-03-24",{"date":44,"type":45},"2026-03-27","ACTUAL",{"date":47,"type":21},"2026-04-15",{"date":49,"type":21},"2028-09-30",{"name":51,"class":52},"A.M.I. Agency for Medical Innovations GmbH","INDUSTRY",5,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":5},"100404550","phase-3-efficacy-of-conservative-treatment-of-functional-defecatory-disorders-in-females-with-pelvic-organ-prolapse-100404550","NCT04547816","Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse","Evaluation of Complex (Physical Therapy and Diet) Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse","Inclusion Criteria:\n\n* Willingness to participate (signed informed consent form)\n* Females with rectocele I-II grade or rectocele I-II grade and internal rectal invagination and functional defecatory disorders (per Rome IV guidelines) confirmed on the basis of complex examination including high-resolution anorectal manometry\n\nExclusion Criteria:\n\n* rectocele III grade;\n* internal genitals prolapse;\n* history of abdominal or pelvic surgery that may impact bowel motility (excluding non-complicated appendectomy or laparoscopic cholecystectomy);\n* gynecological surgery that may influence sensory or reservoir function of rectum;\n* history of major cardiovascular events, or presence of current conditions that in case of participation of the patient in the study may put her at risk of exacerbation or complication;\n* start of any new concomitant medication with mechanisms of action that influence rectal motility, sensory function, muscle tone and\u002For contractility\n* inability to understand and\u002For follow the instructions to perform all the procedures required per protocol\n* general condition of the patient that make her ineligible by the discretion of the investigator","70 Years",{"count":20,"type":21},[64],"PHASE3","This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse",[32,67,68],"Functional Constipation","Rectocele",[70,71,72,73,74,75,76],"pelvic floor prolapse","conservative treatment","functional disorders of defecation","rectocele","diet modification","biofeedback therapy","tibial neuromodulation","RECRUITING","2025-08-01",{"date":80,"type":45},"2025-08-03",{"date":82,"type":45},"2020-07-01",{"date":84,"type":21},"2026-05-31",{"name":86,"class":87},"Federal State Budgetary Scientific Institution \"Federal Research Centre of Nutrition, Biotechnology","OTHER"]