[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stimuli Technology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Overactive Bladder (OAB)",[28,29,30],"Overactive Bladder","Transcutaneous Tibial Nerve Stimulation","Urology","NOT_YET_RECRUITING","2026-04-22",{"date":34,"type":35},"2026-04-28","ACTUAL",{"date":37,"type":20},"2026-05",{"date":39,"type":20},"2027-01",{"name":41,"class":42},"Stimuli Technology","INDUSTRY",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100608737","tensi-european-registry-100608737","NCT07205445","Tensi+ European Registry","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients suffering from idiopathic or neurological overactive bladder\n\nExclusion Criteria:\n\n* Patients with pacemaker, defibrillator, or any other electronic implant;\n* Patients with metal implant near the stimulation area;\n* Pregnant women;\n* People suffering from ankle joint problems, swollen ankles or a dermatological condition or damaged skin in the area where the electrodes are to be placed;\n* Patient with cognitive impairment;\n* Inability to complete a voiding diary;\n* No social security cover (for applicable countries).","18 Years",{"count":52,"type":20},500,"1 Year","OBSERVATIONAL","Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management. Preliminary studies have shown a favorable safety and efficacy profile. The goal of the present registry is to collect data among an important number of patients to assess the efficacy, safety and potential predictive factors of success in a current clinical setting over a total period of 1 year.",[28],[30,58,59],"TENS","Overactive bladder","RECRUITING","2025-09-30",{"date":63,"type":35},"2025-10-03",{"date":65,"type":35},"2025-02-27",{"date":67,"type":20},"2027-10-01",{"name":41,"class":42},17,""]