[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608737":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":42,"studyPopulation":45,"armGroups":42,"interventions":46,"overallOfficials":42,"centralContacts":51,"locations":60,"responsibleParty":276,"collaborators":42,"id":278,"slug":42,"hasResults":279,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":42,"eligibilityCriteria":282,"healthyVolunteers":279,"sex":283,"minAge":284,"maxAge":42,"enrollmentInfo":285,"targetDuration":288,"studyType":289,"phases":42,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":63,"whyStopped":42,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},{"fullName":5,"class":6},"Stimuli Technology","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Subjective improvement","The Patient Global Impression of Improvement (PGI-I) uses a 7-point scale, where post-treatment condition is rated as follows:\n\n1. = Very much better\n2. = Much better\n3. = A little better\n4. = No change\n5. = A little worse\n6. = Much worse\n7. = Very much worse.\n\nFor analysis, patients with a PGI-I score of 1, 2, or 3 are typically considered responders, reflecting meaningful improvement.","3 and 12 months",[14,18,20],{"measure":15,"description":16,"timeFrame":17},"Patient-reported Outcomes Measures (PROMs)","Urinary symptoms by filling up International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) which is a questionnaire intended to assess female storage, voiding and incontinence symptoms. Lower scores are typically associated with reduced symptom severity.","0; 3 and 12 months",{"measure":15,"description":19,"timeFrame":17},"Urinary symptoms by filling up International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) which is a questionnaire intended to assess male storage, voiding and incontinence symptoms. Lower scores are typically associated with reduced symptom severity.",{"measure":21,"description":22,"timeFrame":17},"Quality of life measures","By filling up International Consultation on Incontinence Questionnaire - OAB quality of life (ICIQ-OABqol) which is a questionnaire evaluating quality of life in patients with overactive bladder. Lower scores are typically associated with improved quality of life.",[24,26,29,32,35,38],{"measure":15,"description":25,"timeFrame":17},"By filling up International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B) which is a questionnaire for evaluating symptoms of anal incontinence. Lower scores are typically associated with reduced symptom severity.",{"measure":27,"description":28,"timeFrame":17},"Evaluation of voiding frequency","Evaluation of daytime voiding frequency averaged over three days from bladder diary entries",{"measure":30,"description":31,"timeFrame":17},"Evaluation of urgency","Evaluation of daily urgency episodes averaged over three days from bladder diary entries",{"measure":33,"description":34,"timeFrame":17},"Evaluation of nocturia","Evaluation of nocturia episodes averaged over three days from bladder diary entries",{"measure":36,"description":37,"timeFrame":17},"Evaluation of urgency urinary incontinence","Evaluation of urgency urinary incontinence episodes averaged over three days from bladder diary entries",{"measure":39,"description":40,"timeFrame":12},"Evaluation of adverse events","Patients will be asked whether they experienced any adverse events during treatment. Patient responses will be collected and described qualitatively, enabling the identification of the types of adverse events reported as well as the frequency of their occurrence.",{"allocation":42,"interventionModel":42,"interventionModelDescription":42,"primaryPurpose":42,"observationalModel":43,"timePerspective":44,"maskingInfo":42},null,"COHORT","PROSPECTIVE","Age ≥ 18 years Overactive bladder symptoms",[47],{"type":48,"name":49,"description":50,"armGroupLabels":42,"otherNames":42},"DEVICE","Tensi+","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.",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":42,"email":56},"Akshaya Mariadassou","CONTACT","+331 84 60 48 25","a.mariadassou@stimuli-technology.com",{"name":58,"role":54,"phone":55,"phoneExt":42,"email":59},"Sarah Todeschini","s.todeschini@stimuli-technology.com",[61,79,93,101,115,132,146,158,172,186,195,204,215,223,232,248,262],{"facility":62,"status":63,"city":64,"state":42,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"HFME - Hospices Civils de Lyon","RECRUITING","Bron","69500","France","FR",{"type":69,"coordinates":70},"Point",[71,72],4.91303,45.73865,{"lat":72,"lon":71},[75],{"name":76,"role":54,"phone":77,"phoneExt":42,"email":78},"Gery Lamblin, MD, PhD","+334 27 85 53 53","gery.lamblin@chu-lyon.fr",{"facility":80,"status":63,"city":81,"state":42,"zip":82,"country":66,"countryCode":67,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"CHU de Rennes","Rennes","35033",{"type":69,"coordinates":84},[85,86],-1.67431,48.11109,{"lat":86,"lon":85},[89],{"name":90,"role":54,"phone":91,"phoneExt":42,"email":92},"Benoît Peyronnet, MD, PhD","+332 99 28 90 48","peyronnetbenoit@hotmail.fr",{"facility":80,"status":63,"city":81,"state":42,"zip":82,"country":66,"countryCode":67,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},{"type":69,"coordinates":95},[85,86],{"lat":86,"lon":85},[98],{"name":99,"role":54,"phone":42,"phoneExt":42,"email":100},"Juan Penafiel, MD","jfcopenafiel@gmail.com",{"facility":102,"status":63,"city":103,"state":42,"zip":104,"country":66,"countryCode":67,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"CHU de Rouen - Hôpital Charles Nicolle","Rouen","76031",{"type":69,"coordinates":106},[107,108],1.09932,49.44313,{"lat":108,"lon":107},[111],{"name":112,"role":54,"phone":113,"phoneExt":42,"email":114},"Jean-Nicolas Cornu, MD, PhD","+332 32 88 03 41","jeannicolas.cornu@gmail.com",{"facility":116,"status":117,"city":118,"state":42,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Nuova Villa Esther","NOT_YET_RECRUITING","Avellino","83100","Italy","IT",{"type":69,"coordinates":123},[124,125],14.79103,40.91494,{"lat":125,"lon":124},[128],{"name":129,"role":54,"phone":130,"phoneExt":42,"email":131},"Luca Cindolo, MD, PhD","+39 0825 772111","lucacindolo@virgilio.it",{"facility":133,"status":117,"city":134,"state":42,"zip":135,"country":120,"countryCode":121,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Azienda Ospedaliero-Universitaria Careggi","Florence","50139",{"type":69,"coordinates":137},[138,139],11.24626,43.77925,{"lat":139,"lon":138},[142],{"name":143,"role":54,"phone":144,"phoneExt":42,"email":145},"Stefania Musco, MD, PhD","+39 055 794 111","stefaniamusco@hotmail.com",{"facility":147,"status":117,"city":148,"state":42,"zip":149,"country":120,"countryCode":121,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Hesperia Hospital","Modena","41125",{"type":69,"coordinates":151},[152,153],10.92539,44.64783,{"lat":153,"lon":152},[156],{"name":129,"role":54,"phone":157,"phoneExt":42,"email":131},"+39 059 449111",{"facility":159,"status":117,"city":160,"state":42,"zip":161,"country":120,"countryCode":121,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Santa Maria la Gruccia Hospital","Montevarchi","52025",{"type":69,"coordinates":163},[164,165],11.57238,43.5252,{"lat":165,"lon":164},[168],{"name":169,"role":54,"phone":170,"phoneExt":42,"email":171},"Marilena Gubbiotti, MD, PhD","+39 055 9106695","marilena.gubbiotti@gmail.com",{"facility":173,"status":117,"city":174,"state":42,"zip":175,"country":120,"countryCode":121,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Policlinico Tor Vergata","Roma","00133",{"type":69,"coordinates":177},[178,179],11.10642,44.99364,{"lat":179,"lon":178},[182],{"name":183,"role":54,"phone":184,"phoneExt":42,"email":185},"Enrico Finazzi Agrò, MD, PhD","+39 06 2090 2977","finazzi.agro@med.uniroma2.it",{"facility":187,"status":117,"city":174,"state":42,"zip":188,"country":120,"countryCode":121,"cosmosGeoPoint":189,"geoPoint":191,"contacts":192},"Casa di Cura Villa Stuart","00135",{"type":69,"coordinates":190},[178,179],{"lat":179,"lon":178},[193],{"name":129,"role":54,"phone":194,"phoneExt":42,"email":131},"+39 06 3552 8500",{"facility":196,"status":117,"city":174,"state":42,"zip":197,"country":120,"countryCode":121,"cosmosGeoPoint":198,"geoPoint":200,"contacts":201},"Villa Salaria Hospital","00139",{"type":69,"coordinates":199},[178,179],{"lat":179,"lon":178},[202],{"name":129,"role":54,"phone":203,"phoneExt":42,"email":131},"+39 06 887 0041",{"facility":205,"status":117,"city":174,"state":42,"zip":206,"country":120,"countryCode":121,"cosmosGeoPoint":207,"geoPoint":209,"contacts":210},"Azienda Ospedaliero Universitaria Sant'Andrea","00189",{"type":69,"coordinates":208},[178,179],{"lat":179,"lon":178},[211],{"name":212,"role":54,"phone":213,"phoneExt":42,"email":214},"Cosimo De Nunzio, MD, PhD","+39 06 3377 5929","cosimodenunzio@virgilio.it",{"facility":205,"status":117,"city":174,"state":42,"zip":206,"country":120,"countryCode":121,"cosmosGeoPoint":216,"geoPoint":218,"contacts":219},{"type":69,"coordinates":217},[178,179],{"lat":179,"lon":178},[220],{"name":221,"role":54,"phone":213,"phoneExt":42,"email":222},"Antonio Nacchia, MD, PhD","antonionacchia7@gmail.com",{"facility":224,"status":117,"city":174,"state":42,"zip":225,"country":120,"countryCode":121,"cosmosGeoPoint":226,"geoPoint":228,"contacts":229},"Clinica Nuova Villa Claudia","00191",{"type":69,"coordinates":227},[178,179],{"lat":179,"lon":178},[230],{"name":129,"role":54,"phone":231,"phoneExt":42,"email":131},"+39 06 367971",{"facility":233,"status":117,"city":234,"state":42,"zip":235,"country":236,"countryCode":237,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Bristol Urological Institute","Bristol","BS10 5NB","United Kingdom","UK",{"type":69,"coordinates":239},[240,241],-2.59665,51.45523,{"lat":241,"lon":240},[244],{"name":245,"role":54,"phone":246,"phoneExt":42,"email":247},"Hashim Hashim, MD, PhD","+44 117 950 5050","h.hashim@gmail.com",{"facility":249,"status":117,"city":250,"state":42,"zip":251,"country":236,"countryCode":237,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Addenbrooke's Hospital, Cambridge University Hospital Trust","Cambridge","CB22 0QQ",{"type":69,"coordinates":253},[254,255],0.11667,52.2,{"lat":255,"lon":254},[258],{"name":259,"role":54,"phone":260,"phoneExt":42,"email":261},"Suzanne Biers, MD","+44 1223 216575","suzanne.biers@.nhs.net",{"facility":263,"status":117,"city":264,"state":42,"zip":265,"country":236,"countryCode":237,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"University College Hospital London","London","NW1 2BU",{"type":69,"coordinates":267},[268,269],-0.12574,51.50853,{"lat":269,"lon":268},[272],{"name":273,"role":54,"phone":274,"phoneExt":42,"email":275},"Mahreen Pakzad, MD","+44 20 3456 7890","mahreen.pakzad@nhs.net",{"type":277,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100608737",false,"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).","ALL","18 Years",{"count":286,"type":287},500,"ESTIMATED","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.",[292],"Overactive Bladder",[294,295,296],"Urology","TENS","Overactive bladder","2025-09-30",{"date":299,"type":300},"2025-10-03","ACTUAL",{"date":302,"type":300},"2025-02-27",{"date":304,"type":287},"2027-10-01",{"name":5,"class":6},17]