[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616076":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":24,"locations":33,"responsibleParty":84,"collaborators":11,"id":86,"slug":11,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":11,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":11,"enrollmentInfo":94,"targetDuration":11,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":106,"whyStopped":11,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"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",[34,53,68],{"facility":35,"status":11,"city":36,"state":37,"zip":38,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Cedars-Sinai","Beverly Hills","California","90211","United States",{"type":41,"coordinates":42},"Point",[43,44],-118.40036,34.07362,{"lat":44,"lon":43},[47,51],{"name":48,"role":27,"phone":49,"phoneExt":11,"email":50},"Karyn Eilber","310-385-2992","Karyn.Eilber@cshs.org",{"name":48,"role":52,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":54,"status":11,"city":55,"state":55,"zip":56,"country":39,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"NYU Langone Health","New York","10017",{"type":41,"coordinates":58},[59,60],-74.00597,40.71427,{"lat":60,"lon":59},[63,67],{"name":64,"role":27,"phone":65,"phoneExt":11,"email":66},"Benjamin Brucker","646-825-6324","benjamin.brucker@nyulangone.org",{"name":64,"role":52,"phone":11,"phoneExt":11,"email":11},{"facility":69,"status":11,"city":70,"state":11,"zip":11,"country":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Toronto Western Hospital","Toronto","Canada",{"type":41,"coordinates":73},[74,75],-79.39864,43.70643,{"lat":75,"lon":74},[78,83],{"name":79,"role":27,"phone":80,"phoneExt":81,"email":82},"Dean Elterman","416 603 5800","ext. 5033","Dean.Elterman@uhn.ca",{"name":79,"role":52,"phone":11,"phoneExt":11,"email":11},{"type":85,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":95,"type":96},60,"ESTIMATED","INTERVENTIONAL",[99],"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.",[102],"Overactive Bladder (OAB)",[104,22,105],"Overactive Bladder","Urology","NOT_YET_RECRUITING","2026-04-22",{"date":109,"type":110},"2026-04-28","ACTUAL",{"date":112,"type":96},"2026-05",{"date":114,"type":96},"2027-01",{"name":5,"class":6},3]