[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568266":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":39,"responsibleParty":152,"collaborators":11,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":11,"eligibilityCriteria":159,"healthyVolunteers":156,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":11,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":11,"overallStatus":172,"whyStopped":11,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"TBF Genie Tissulaire","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treated umbilical vein allograft","EXPERIMENTAL",null,[13],"Procedure: with treated umbilical vein allograft",{"label":15,"type":16,"description":11,"interventionNames":17},"Autologous Fascial Pubovaginal Sling","ACTIVE_COMPARATOR",[18],"Procedure: with autologous fascial pubovaginal sling",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","with treated umbilical vein allograft","Surgical treatment of female stress urinary incontinence using a treated allogeneic umbilical vein sling",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"with autologous fascial pubovaginal sling","Surgical treatment of female stress urinary incontinence using a autologous fascial pubovaginal sling",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Laurence BARNOUIN, MD","CONTACT","+33472686909","laurence.barnouin@tbf-lab.com",{"name":36,"role":32,"phone":37,"phoneExt":11,"email":38},"Justine BOSC, MSc","+33472686911","justine.bosc@tbf-lab.com",[40,56,68,83,100,114,126,140],{"facility":41,"status":11,"city":42,"state":11,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Hôpital Estaing, CHU de Clermont-Ferrand","Clermont-Ferrand","63100","France","FR",{"type":47,"coordinates":48},"Point",[49,50],3.08682,45.77969,{"lat":50,"lon":49},[53],{"name":54,"role":55,"phone":11,"phoneExt":11,"email":11},"Sandrine Campagne-Loiseau, MD","PRINCIPAL_INVESTIGATOR",{"facility":57,"status":11,"city":58,"state":11,"zip":59,"country":44,"countryCode":45,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Hôpital Michalon, CHU de Grenoble Alpes","La Tronche","38700",{"type":47,"coordinates":61},[62,63],5.74629,45.20507,{"lat":63,"lon":62},[66],{"name":67,"role":55,"phone":11,"phoneExt":11,"email":11},"Caroline THUILLIER, MD",{"facility":69,"status":11,"city":70,"state":11,"zip":71,"country":44,"countryCode":45,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hôtel-Dieu, CHU de Nantes","Nantes","44000",{"type":47,"coordinates":73},[74,75],-1.55336,47.21725,{"lat":75,"lon":74},[78,80],{"name":79,"role":55,"phone":11,"phoneExt":11,"email":11},"Marie-Aimée PERROUIN-VERBE, Professor",{"name":81,"role":82,"phone":11,"phoneExt":11,"email":11},"Marie-Liesse DE GUERRY DE BEAUREGARD, MD","SUB_INVESTIGATOR",{"facility":84,"status":11,"city":85,"state":11,"zip":86,"country":44,"countryCode":45,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hôpital de la Pitié-Salpêtrière, Assistance Publique des Hôpitaux de Paris","Paris","75013",{"type":47,"coordinates":88},[89,90],2.3488,48.85341,{"lat":90,"lon":89},[93,98],{"name":94,"role":32,"phone":95,"phoneExt":96,"email":97},"Kamilia ZEDEK","184828323","+33","kamilia.zedek@aphp.fr",{"name":99,"role":55,"phone":11,"phoneExt":11,"email":11},"Emmanuel CHARTIER-KASTLER, Professor",{"facility":101,"status":11,"city":102,"state":11,"zip":103,"country":44,"countryCode":45,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Hôpital Lyon Sud, Hospices Civils de Lyon","Pierre-Bénite","69495",{"type":47,"coordinates":105},[106,107],4.82424,45.70359,{"lat":107,"lon":106},[110,112],{"name":111,"role":55,"phone":11,"phoneExt":11,"email":11},"Alain RUFFION, Professor",{"name":113,"role":82,"phone":11,"phoneExt":11,"email":11},"Théo ARBER, MD",{"facility":115,"status":11,"city":116,"state":11,"zip":117,"country":44,"countryCode":45,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Hôpital Charles-Nicolle, CHU de Rouen","Rouen","76000",{"type":47,"coordinates":119},[120,121],1.09932,49.44313,{"lat":121,"lon":120},[124],{"name":125,"role":55,"phone":11,"phoneExt":11,"email":11},"Jean-Nicolas CORNU, Professor",{"facility":127,"status":11,"city":128,"state":11,"zip":129,"country":44,"countryCode":45,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Nouvel hôpital civil, Hôpitaux Universitaires de Strasbourg","Strasbourg","67091",{"type":47,"coordinates":131},[132,133],7.74553,48.58392,{"lat":133,"lon":132},[136,138],{"name":137,"role":55,"phone":11,"phoneExt":11,"email":11},"Christian SAUSSINE, Professor",{"name":139,"role":82,"phone":11,"phoneExt":11,"email":11},"Baptiste POUSSOT, MD",{"facility":141,"status":11,"city":142,"state":11,"zip":143,"country":44,"countryCode":45,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Hôpital Rangueil, CHU de Toulouse","Toulouse","31400",{"type":47,"coordinates":145},[146,147],1.44367,43.60426,{"lat":147,"lon":146},[150],{"name":151,"role":55,"phone":11,"phoneExt":11,"email":11},"Xavier GAME, Professor",{"type":153,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100568266","phase-3-treated-umbilical-vein-allograft-uvt-versus-autologous-fascial-pubovaginal-sling-in-the-treatment-of-female-stress-urinary-incontinence-100568266",false,"NCT06678984","Treated Umbilical Vein Allograft (UVT) Versus Autologous Fascial Pubovaginal Sling in the Treatment of Female Stress Urinary Incontinence","Inclusion Criteria:\n\n* Women aged 18 to 85 years.\n* Patients with stress urinary incontinence or mixed urinary incontinence with a predominant stress component.\n* Patients with stress urinary incontinence due to cervico-urethral hypermobility or urethral hypermobility.\n* Patients with urethral hypermobility confirmed by Ulmsten suburethral support maneuver.\n* Urinary incontinence demonstrated by one-hour pad test.\n* Patients with significant and persistent discomfort despite perineal rehabilitation.\n* Patients able to understand the information concerning the study and having voluntarily dated and signed the informed consent form.\n* Patients able and willing to comply with the requirements and instructions of the study.\n* Patients who are members or the beneficiary of a national health insurance plan.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women or those not using effective contraception.\n* Patients with a body mass index (BMI) ≥ 35 kg\u002Fm2.\n* Patients with moderate stress urinary incontinence treated with physiotherapy and pelvic support exercises.\n* Patients with voiding disorders or at risk of performing self-catheterization.\n* Patients who have already undergone surgical treatment for urinary incontinence.\n* Patients unable to perform the pad test or unwilling to perform it at each follow-up visit.\n* Patients considered by the principal investigator to be poor candidates for surgical procedures and\u002For anesthesia due to their physical or mental state.\n* Patients with current urinary tract infection, severe anemia, uncontrolled diabetes or other conditions contraindicating surgery.\n* Patients with neurogenic bladder.\n* Patients with a history of conditions, illnesses or surgical procedures that may confound the results of the urinary incontinence assessment, including but not limited to: pelvic organ prolapse (e.g., cystocele, rectocele), neurological disorders (e.g., multiple sclerosis, Parkinson's disease), recurrent urinary tract infections, recurrent bladder stones, interstitial cystitis, history of pelvic irradiation (external beam therapy or brachytherapy), current diagnosis of genitourinary malignancy.\n* Patients deprived of liberty by a judicial or administrative decision.\n* Patients incapable of discernment for rehabilitation, unable to follow up or give consent.","FEMALE","18 Years","85 Years",{"count":164,"type":165},96,"ESTIMATED","INTERVENTIONAL",[168],"PHASE3","The goal of this clinical trial is to evaluate whether a treated umbilical vein allograft is effective in treating stress urinary incontinence in females. The researchers will compare the treated umbilical vein allograft with a sling made of autologous tissue. The main question the clinical trial aims to answer is:\n\n\\- Is the treated umbilical vein allograft as effective as the sling made of autologous tissue for treating female stress urinary incontinence?\n\nParticipants will:\n\n* Undergo surgical treatment with either the umbilical vein allograft or the sling made of autologous tissue on Day 0.\n* Visit the hospital for a series of tests at 3 weeks, 3 months, 6 months, and 12 months after the surgical intervention.\n* Record their bladder activity between each hospital visit.",[171],"Stress Urinary Incontinence in Women","NOT_YET_RECRUITING","2025-09-24",{"date":175,"type":176},"2025-09-30","ACTUAL",{"date":178,"type":165},"2025-10",{"date":180,"type":165},"2028-05-01",{"name":5,"class":6},8]