[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399250":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":29,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":29,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":29,"overallStatus":46,"whyStopped":29,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Helsinki University Central Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Transvaginal mesh","ACTIVE_COMPARATOR","BSC mesh (A.M.I., Feldkirch, Austria) is attached to the sacrospinosus ligaments and to the apical part of the vagina.",[13],"Procedure: TVM",{"label":15,"type":10,"description":16,"interventionNames":17},"Colposacropexy with the apical fixation only","EndoGYNious (A.M.I.) CSP mesh is attached laparoscopically to the apical part of the vagina.",[18],"Procedure: Colposacropexy",{"label":20,"type":10,"description":21,"interventionNames":22},"Colposacropexy with the apical and the levator fixation","EndoGYNious (A.M.I.) CSP mesh is attached laparoscopically to the apical part of the vagina with fixation reaching to the level of the levator planes.",[18],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","TVM","Transvaginal mesh operation using BSC mesh (A.M.I., Feldkirch, Austria)",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Colposacropexy","Colposacropexy using EndoGYNious mesh (A.M.I., Feldkirch, Austria)",[20,15],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},"Tomi Mikkola, Prof.","CONTACT","+358504271187","tomi.mikkola@hus.fi",{"name":41,"role":37,"phone":29,"phoneExt":29,"email":42},"Camilla Isaksson, MD","camilla.isaksson@hus.fi",[44],{"facility":45,"status":46,"city":47,"state":29,"zip":29,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Helsinki Naistenklinikka","RECRUITING","Helsinki","Finland","FI",{"type":51,"coordinates":52},"Point",[53,54],24.93545,60.16952,{"lat":54,"lon":53},[57],{"name":58,"role":37,"phone":29,"phoneExt":29,"email":29},"Camilla Isaksson, Senior consultant",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Camilla Isaksson","Senior consultant","100399250","transvaginal-mesh-vs-laparoscopic-colposacropexy--study-100399250",false,"NCT04478747","Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study","Women's Apical Pelvic Organ Prolapse Treatment - a Randomized Controlled Trial Comparing Transvaginal and Laparoscopic Mesh Surgery","TVM vs LCSP","Inclusion Criteria:\n\n* Age over 18 years and capability to understand the study protocol either in Finnish or Swedish.\n* Objectively diagnosed symptomatic apical prolapse (leading apical prolapse (points C\u002FD) ≥ -2) and a history of previous POP operation including hysterectomy.\n* No need for any other concomitant operations except colporrhaphies and possible prophylactic salpingo-oophorectomy in CSP groups\n\nExclusion Criteria:\n\n* A history of serious or prolonged pain after any operation or current or previous prolonged (over 6 months) pain of any reason.\n* BMI over 40\n* Regular use of systemic corticosteroid medication.\n* Incapability to understand the study protocol.",true,"FEMALE","18 Years","99 Years",{"count":76,"type":77},318,"ESTIMATED","INTERVENTIONAL",[80],"NA","The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane.\n\nThe secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.",[83],"Prolapse, Vaginal Vault","2025-09-19",{"date":86,"type":87},"2025-09-24","ACTUAL",{"date":89,"type":87},"2020-07-01",{"date":91,"type":77},"2032-12",{"name":5,"class":6},1]