[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485528":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":45,"locations":54,"responsibleParty":159,"collaborators":49,"id":162,"slug":163,"hasResults":164,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":164,"sex":169,"minAge":170,"maxAge":49,"enrollmentInfo":171,"targetDuration":49,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":182,"overallStatus":94,"whyStopped":49,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transobturator cystocele repair (TOCR)","EXPERIMENTAL","The technique of TOCR was published previously including a video \\[Kalis et al. Trans-obturator cystocele repair (TOCR) of level 2 paravaginal defect. Int Urogynecol J. 2020, 31(11):2435-38. doi:10.1007\u002Fs00192-020-04337-x\\].\n\nThe anterior vaginal wall is incised in the midline and the pubocervical fascia is dissected to open the paravaginal space towards the ATFP and the fascia of the obturator internus muscle. 3-4 continuous non-locking stitches of non-absorbable suture 1-0 Ti-Cron™ braided polyester are taken into the pubocervical fascia and threaded using Shirodkar needles through skin incisions in genitofemoral sulci passing through the full thickness of the obturator membrane, obturator internus muscle. After closure of the vaginal skin incision, both ends of the Ti-Cron™ sutures are tied ensuring the obliteration of the paravaginal defect.\n\nIndometacin rectal suppository 100 mg is inserted transrectally for early postoperative pain management.",[13],"Procedure: Transobturator cystocele repair",{"label":15,"type":16,"description":17,"interventionNames":18},"standard anterior colporrhaphy (anterior repair - AR)","ACTIVE_COMPARATOR","The anterior vaginal wall is incised in the midline from the level of the bladder neck up to vaginal apex or anterior vaginal fornix. The bladder is sharply dissected from the vaginal wall with pubocervical fascia attached to the bladder wall. The fascia is approximated in the midline with several simple interrupted 0 polyglactin 910 sutures or equivalent. The surplus of distended vaginal epithelium is trimmed. The vaginal incision is closed using a continuous non-locking polyglactin 910 2-0 suture or equivalent. Indometacin rectal suppository 100 mg is inserted transrectally for early postoperative pain management.",[19],"Procedure: Anterior colporrhaphy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Transobturator cystocele repair","Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.",[9],[27],"TOCR",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Anterior colporrhaphy","The traditional transvaginal surgery for cystocele treatment used as a comparator in the study",[15],[33],"Anterior repair",[35,39,42],{"name":36,"affiliation":37,"role":38},"Vladimir Kalis, prof. MD PhD","Faculty of Medicine in Plzen, Charles University","STUDY_CHAIR",{"name":40,"affiliation":37,"role":41},"Khaled MK Ismail, MBBCh, MSc, MD, PhD, FRCOG","STUDY_DIRECTOR",{"name":43,"affiliation":37,"role":44},"Zdenek Rusavy, assoc. prof. MD PhD","PRINCIPAL_INVESTIGATOR",[46,51],{"name":36,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","+420377105228",null,"kalisv@fnplzen.cz",{"name":43,"role":47,"phone":52,"phoneExt":49,"email":53},"+420377105440","rusavyz@fnplzen.cz",[55,71,79,92,105,118,131,146],{"facility":56,"status":57,"city":58,"state":49,"zip":59,"country":60,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Faculty of Medicine in Hradec Kralove, Charles University","NOT_YET_RECRUITING","Hradec Králové","500 05","Czechia",{"type":62,"coordinates":63},"Point",[64,65],15.83277,50.20923,{"lat":65,"lon":64},[68],{"name":69,"role":47,"phone":49,"phoneExt":49,"email":70},"Ondřej Dvořák, MD PhD","dvorino@centrum.cz",{"facility":72,"status":57,"city":73,"state":49,"zip":74,"country":60,"countryCode":49,"cosmosGeoPoint":49,"geoPoint":49,"contacts":75},"Medical Faculty, Ostrava University","Ostrava-Poruba","708 52",[76],{"name":77,"role":47,"phone":49,"phoneExt":49,"email":78},"Olga Szabová, MD","olga.szabova@fno.cz",{"facility":80,"status":57,"city":81,"state":49,"zip":82,"country":60,"countryCode":49,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Hospital Pardubice Region, Inc.","Pardubice","530 03",{"type":62,"coordinates":84},[85,86],15.77659,50.04075,{"lat":86,"lon":85},[89],{"name":90,"role":47,"phone":49,"phoneExt":49,"email":91},"Germund Hensel, MD","germund.hensel@nempk.cz",{"facility":93,"status":94,"city":95,"state":49,"zip":96,"country":60,"countryCode":49,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Faculty of Medicine in Pilsen, Charles University","RECRUITING","Pilsen","30000",{"type":62,"coordinates":98},[99,100],13.37759,49.74747,{"lat":100,"lon":99},[103],{"name":104,"role":47,"phone":52,"phoneExt":49,"email":53},"Zdenek Rusavy, MD PhD",{"facility":106,"status":57,"city":107,"state":49,"zip":108,"country":60,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Hospital na Bulovce, 1st Medical Faculty, Charles University","Prague","18000",{"type":62,"coordinates":110},[111,112],14.42076,50.08804,{"lat":112,"lon":111},[115],{"name":116,"role":47,"phone":49,"phoneExt":49,"email":117},"Petr Hubka, MD PhD","petr.hubka@bulovka.cz",{"facility":119,"status":57,"city":120,"state":49,"zip":121,"country":60,"countryCode":49,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Tomas Bata Regional Hospital in Zlin","Zlín","762 75",{"type":62,"coordinates":123},[124,125],17.67065,49.22645,{"lat":125,"lon":124},[128],{"name":129,"role":47,"phone":49,"phoneExt":49,"email":130},"Zdeněk Adamík, MD","zdenek.adamik@icloud.com",{"facility":132,"status":57,"city":133,"state":49,"zip":134,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Košice Medical University","Košice","040 11","Slovakia","SK",{"type":62,"coordinates":138},[139,140],21.25802,48.71441,{"lat":140,"lon":139},[143],{"name":144,"role":47,"phone":49,"phoneExt":49,"email":145},"Peter Urdzík, prof. MD Ph.D.","peter.urdzik@upjs.sk",{"facility":147,"status":57,"city":148,"state":49,"zip":149,"country":135,"countryCode":136,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Trenčianska univerzita Alexandra Dubčeka","Trenčín","911 01",{"type":62,"coordinates":151},[152,153],18.04436,48.89452,{"lat":153,"lon":152},[156],{"name":157,"role":47,"phone":49,"phoneExt":49,"email":158},"Matej Vidoman, MD","vidoman.matej@gmail.com",{"type":44,"investigatorFullName":160,"investigatorTitle":161,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Zdenek Rusavy","assoc. prof. MD PhD","100485528","study-comparing-transobturator-cystocele-vs-anterior-vaginal-repairs-100485528",false,"NCT05602246","Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS","STARS","Inclusion Criteria:\n\n* (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1)\n* Age ≥ 50 years\n* Symptom bulge\n* Ability to speak Czech or English\n\nExclusion Criteria:\n\n* Malignancy","FEMALE","50 Years",{"count":172,"type":173},592,"ESTIMATED","INTERVENTIONAL",[176],"NA","Surgical correction of the prolapse in the anterior compartment remains one of the major challenges in urogynecology. Paravaginal defect in level II of vaginal fixation results in the majority of cystoceles. Clinically, these defects are often combined and\u002For may be bilateral. Hence, careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome. Several surgical techniques and approaches have been used for cystocele repair. After the ban on transvaginal meshes, the interest in native tissue repair has risen. Paravaginal defect repair is an effective surgery for paravaginal defect reconstruction. There is a current trend to utilize transvaginal surgery instead of more invasive transabdominal surgery. A novel method of transvaginal paravaginal defect repair - TOCR (transobturator cystocele repair) was suggested. The principle objective of the present trial is to compare its efficacy and safety to preexisting method of native tissue cystocele repair.",[179,180,181],"Pelvic Organ Prolapse","Cystocele","Cystocele and Incomplete Uterovaginal Prolapse",[183,184,27,185,23],"Pelvic organ prolapse","Quality of life","Anterior vaginal wall repair","2026-03-18",{"date":188,"type":189},"2026-03-19","ACTUAL",{"date":191,"type":189},"2022-12-01",{"date":193,"type":173},"2034-11-01",{"name":5,"class":6},8]