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Hospital","NOT_YET_RECRUITING","Mannheim",{"type":46,"coordinates":103},[104,105],8.46694,49.4891,{"lat":105,"lon":104},[108],{"name":109,"role":31,"phone":10,"phoneExt":10,"email":10},"Benjamin Tuschy, Prof. Dr. med.",{"facility":111,"status":41,"city":112,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Hospital Tettnang","Tettnang",{"type":46,"coordinates":114},[115,116],9.59132,47.66857,{"lat":116,"lon":115},[119],{"name":120,"role":31,"phone":10,"phoneExt":10,"email":10},"Christian Fünfgeld, Dr.med.",{"type":122,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100442520","long-term-evaluation-of-the-efficacy-and-safety-of-splentis-for-the-treatment-of-primary-apical-pelvic-organ-prolapse-100442520",false,"NCT05042453","Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse","Prospective, Multicenter, 60 Months, Single-arm Cohort Trial for Evaluation of the Efficacy and Safety of Transvaginal Sacrospinous Ligament Fixation With Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse","SAXO","Inclusion Criteria:\n\n* non-fertile women\n* primary symptomatic uterine descent POP-Q≥2\n* Scheduled apical POP repair with Splentis\n* Willing and able to participate at study visits and to sign informed consent\n\nExclusion Criteria:\n\n* Fertile women\n* Recurrent apical prolapse\n* Women with post hysterectomy vaginal vault prolapse\n* Patients with active or latent infection of the vagina, cervix or uterus\n* Patients with previous or current vaginal, cervical or uterine cancer\n* Previous, current or planned pelvic radiation therapy\n* Known allergy to polypropylene.","FEMALE","18 Years",{"count":134,"type":135},140,"ESTIMATED","OBSERVATIONAL","This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse",[139],"Pelvic Organ Prolapse",[141,142,143,144],"Apical Pelvic Organ Prolapse","Transvaginal repair","Mesh augmented repair","Sacrouterine ligament fixation","2024-11-19",{"date":147,"type":148},"2024-11-22","ACTUAL",{"date":150,"type":148},"2022-12-19",{"date":152,"type":135},"2030-07",{"name":5,"class":6},7]