[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616076":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":24,"locations":33,"responsibleParty":86,"collaborators":11,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":11,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":11,"enrollmentInfo":97,"targetDuration":11,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":109,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Stimuli Technology","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tensi+ device to be delivered for use by patient","ACTIVE_COMPARATOR",null,[13],"Device: Tensi+",{"label":15,"type":16,"description":11,"interventionNames":17},"Identical Tensi+ Sham device to be delivered for use by patient","SHAM_COMPARATOR",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","Tensi+","Transcutaneous Tibial Nerve Stimulation",[15,9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Akshaya Mariadassou","CONTACT","+331 84 60 48 25","a.mariadassou@stimuli-technology.com",{"name":31,"role":27,"phone":28,"phoneExt":11,"email":32},"Sarah Todeschini","s.todeschini@stimuli-technology.com",[34,54,69],{"facility":35,"status":11,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Cedars-Sinai","Beverly Hills","California","90211","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-118.40036,34.07362,{"lat":45,"lon":44},[48,52],{"name":49,"role":27,"phone":50,"phoneExt":11,"email":51},"Karyn Eilber","310-385-2992","Karyn.Eilber@cshs.org",{"name":49,"role":53,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":55,"status":11,"city":56,"state":56,"zip":57,"country":39,"countryCode":40,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"NYU Langone Health","New York","10017",{"type":42,"coordinates":59},[60,61],-74.00597,40.71427,{"lat":61,"lon":60},[64,68],{"name":65,"role":27,"phone":66,"phoneExt":11,"email":67},"Benjamin Brucker","646-825-6324","benjamin.brucker@nyulangone.org",{"name":65,"role":53,"phone":11,"phoneExt":11,"email":11},{"facility":70,"status":11,"city":71,"state":11,"zip":11,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Toronto Western Hospital","Toronto","Canada","CA",{"type":42,"coordinates":75},[76,77],-79.39864,43.70643,{"lat":77,"lon":76},[80,85],{"name":81,"role":27,"phone":82,"phoneExt":83,"email":84},"Dean Elterman","416 603 5800","ext. 5033","Dean.Elterman@uhn.ca",{"name":81,"role":53,"phone":11,"phoneExt":11,"email":11},{"type":87,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100616076","tensi-for-treating-overactive-bladder-100616076",false,"NCT07300904","Tensi+ for Treating Overactive Bladder","A Randomized, Controlled, Blinded, Prospective, Multi-center Study Evaluating Tensi+ With Transcutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder Syndrome","Inclusion Criteria:\n\n* Adult subjects aged 22 years or older and,\n* Diagnosed with OAB symptoms (characterized by urinary urgency, with or without UUI),\n* Symptoms persisting for at least 3 months, and\n* Documented with 2 or more urgency episodes per day (with or without incontinence) in two 3-day bladder diaries and,\n* With at least 11 or more voids per day (urinary frequency) documented in two 3-day bladder diaries\n* Willing and capable of providing informed consent\n* Capable of participating in all testing associated with this clinical investigation\n\nExclusion Criteria:\n\n* Patients with pacemakers or implanted defibrillators or any other implanted electronic device\n* Patients prone to excessive bleeding\n* Patients with nerve damage that could impact the percutaneous tibial nerve or pelvic floor function\n* Patients who are pregnant or planning to become pregnant while using this product\n* Patients with ankle joint problems, ankle oedema or dermatological oedema in the area where the electrodes should be placed\n* Patients wearing a metal implant near the stimulated area\n* Patient with cognitive deficiency\n* Administration of intravesical injection of botulinum toxin within 12 months of study enrollment, or treatment within the previous year with other forms neuromodulation for OAB\n* Patients treated with medical therapy OAB treatment washout inferior to 30 days\n* Patients with diabetic neuropathy\n* Patients with uncontrolled diabetes and HbA1c levels above 7%\n* Guillain-Barré syndrome\n* Chronic inflammatory demyelinating polyneuropathy (CIDP)\n* Multiple sclerosis\n* A primary diagnosis of stress urinary incontinence (SUI)\n* Patients with recurrent rrinary tract infections (UTIs) defined as more than 2 episodes per year, or with any baseline lower urinary tract pathology identified at the time of the 3-day bladder diary assessment.\n* Currently participating in another clinical trial","ALL","22 Years",{"count":98,"type":99},60,"ESTIMATED","INTERVENTIONAL",[102],"NA","The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency, urgency, with or without urge urinary incontinence.",[105],"Overactive Bladder (OAB)",[107,22,108],"Overactive Bladder","Urology","NOT_YET_RECRUITING","2026-04-22",{"date":112,"type":113},"2026-04-28","ACTUAL",{"date":115,"type":99},"2026-05",{"date":117,"type":99},"2027-01",{"name":5,"class":6},3]