[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566773":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":20,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"DJO UK Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous Tibial Nerve Stimulator (TTNS) with the Cefar Uro Device","EXPERIMENTAL","Patients will undergo Transcutaneous Posterior Tibial Nerve Stimulation with the Cefar URO device. The following parameters setting (preset program P4) will be used for treatment of all enrolled subjects:\n\n* frequency of 20Hz\n* pulse width of 200 μs\n* duration: 30 minutes per treatment.\n* treatment frequency: subjects will be recommended to have 7 treatment sessions per week for a total of 12 weeks (84 treatments total), and anyway no less that one treatment per week.\n\nThe electrodes will be placed in the medial ankle as according to the device IFU.",[13],"Device: Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device","Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar URO device using the preset program P4 (parameter setting: frequency 20Hz, pulse width 200μs) for the symptomatic treatment of urge incontinence in adults with overactive bladder in accordance with the approved labelling.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Gérard Amarenco, Pr.","Service de Neuro-Urologie, Hôpital Tenon","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Veronica Sebeo","CONTACT","+49 15146128712","prci@enovis.com",[33],{"facility":34,"status":20,"city":35,"state":20,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":20},"Neuro-Urology Department, Tenon Hospital","Paris","75020","France","FR",{"type":40,"coordinates":41},"Point",[42,43],2.3488,48.85341,{"lat":43,"lon":42},{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100566773","cefar-uro---symptomatic-treatment-of-overactive-bladder-100566773",false,"NCT06659536","Cefar URO - Symptomatic Treatment of Overactive Bladder","Post-market Prospective Clinical Investigation on the Symptomatic Treatment of Urge Incontinence in Adults With Overactive Bladder With Cefar URO","Inclusion Criteria:\n\n* Adult patients with overactive bladder (including refractory overactive bladder of idiopathic or neurogenic origin) who require symptomatic treatment of urge incontinence and associated symptoms.\n* Subjects, both male and female, ≥ 18 years of age at the time of consent\n* Subjects have provided their written consent to participate in the study by signing the Ethics-approved consent form.\n* Patients are considered able and willing to self-administer transcutaneous tibial nerve stimulator (TTNS) treatment at home, based on Investigator's judgement.\n* Patients are suitable to receive treatment using the Cefar URO device P4 program pre-set parameters (frequency 20Hz and pulse width 200μs) for 12 weeks, based on Investigator's judgement.\n* If undergoing pharmacological therapy for incontinence, the therapy must be stabilized for at least 4 weeks before baseline visit\n\nExclusion Criteria:\n\n* Pregnancy confirmed by urine test at screening\n* Urinary tract infection confirmed by urine analysis\n* Serious secondary illness (such as renal failure, nephrolithiasis, bladder and kidney tumors)\n* Detrusor-sphincter dyssynergia\n* Patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD; or other implantable electronic devices\n* Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers\n* Subjects who are not able to read and understand indications and contraindications of the device\n* Subjects who are not able to sense auditory and visual signals\n* Patients with anti-incontinence surgery planned during the course of the study\n* Participation in another clinical study within 30 days prior to screening","ALL","18 Years",{"count":57,"type":58},53,"ESTIMATED","INTERVENTIONAL",[61],"NA","A Post-Market Prospective Clinical Investigation to collect PMCF data on the safety and performance of the Cefar URO device when using the preset program P4 (parameter setting: frequency 20Hz, pulse width 200μs) for the symptomatic treatment of urge incontinence in adults with overactive bladder in accordance with the approved labelling.\n\nThe Cefar URO device features four pre-set programs (P1, P2, P3 and P4) and three custom programs. Although supporting data on the preset programs P1, P2, P3 are available for the clinically equivalent UROstim2 device, program P4 is unique to Cefar URO. Program P4 utilizes the parameters 20Hz and 200μs which are commonly reported in the literature for the stated indications but for which no data is available for the clinically equivalent UROstim2 device. The present study is therefore aimed to cover this data gap.",[64,65,66],"Overactive Bladder (OAB)","Refractory Overactive Bladder","Urinary Urgency and Frequency",[68,64,69,70],"Urinary urgency","Transcutaneous Tibial Nerve Stimulation (TTNS)","Cefar Uro","NOT_YET_RECRUITING","2025-02-05",{"date":74,"type":75},"2025-02-06","ACTUAL",{"date":77,"type":58},"2025-03",{"date":79,"type":58},"2026-03",{"name":5,"class":6},1]