[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567246":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":7,"responsibleParty":14,"collaborators":7,"id":16,"slug":7,"hasResults":17,"nctId":18,"briefTitle":19,"officialTitle":20,"acronym":21,"eligibilityCriteria":22,"healthyVolunteers":17,"sex":23,"minAge":24,"maxAge":7,"enrollmentInfo":25,"targetDuration":28,"studyType":29,"phases":7,"briefSummary":30,"conditions":31,"keywords":33,"overallStatus":37,"whyStopped":7,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":7},{"fullName":5,"class":6},"DILO Medical","INDUSTRY",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Vincent Goria","CONTACT","+33478425845","contact@dilomedical.fr",{"type":15,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100567246",false,"NCT06665698","Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment","Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women","VIGI-ISTOP","Inclusion Criteria:\n\n* Adult woman aged over 18 ;\n* Patient with SUI, having escaped \"conservative\" medical treatment, with indication for surgical treatment with implantation of an I-STOP® strip via trans-obturator or retropubic route as indicated in the instructions for use of the SUI implant ;\n* Patient affiliated to a social security scheme;\n* Patient capable of completing a self-questionnaire;\n* Patient able to understand the protocol and follow the visit schedule;\n* Patient having signed informed consent.\n\nExclusion Criteria:\n\n* Minor patient, pregnant or breastfeeding ;\n* Adult patient subject to a measure of legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision ;\n* Patient presenting a contraindication to the use of the implant indicated in the instructions for use of the implant ;\n* Patient with a medical contraindication to surgery and\u002For anaesthesia.","FEMALE","18 Years",{"count":26,"type":27},500,"ESTIMATED","10 Years","OBSERVATIONAL","Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence",[32],"Stress Urinary Incontinence (SUI)",[34,35,36],"I-STOP","MUS","Sling","NOT_YET_RECRUITING","2024-10-28",{"date":40,"type":41},"2024-10-30","ACTUAL",{"date":43,"type":27},"2024-11",{"date":45,"type":27},"2034-12",{"name":5,"class":6}]