[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100406534":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":61,"collaborators":48,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":48,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":46,"whyStopped":48,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PTNS verum","EXPERIMENTAL","Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks.",[13],"Device: PTNS de verum",{"label":15,"type":16,"description":17,"interventionNames":18},"PTNS placebo","SHAM_COMPARATOR","Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for 12 weeks (same treatment regimen as the experimental group).",[19],"Device: PTNS placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","PTNS de verum","The device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. The amplitude (Volt) will be adjusted by the patient according to the feeling.",[9],[27],"Peristim Pro (CEFAR-COMPEX®)",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"The device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. A resistor will be incorporated in the device to block the passage of electric current",[15],[32],"Peristim Pro (CEFAR-COMPEX®",[34],{"name":35,"affiliation":5,"role":36},"Xavier Biardeau, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","03.20.44.41.73","+33","xavier.biardeau@chru-lille.fr",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Hop Claude Huriez Chu Lille","RECRUITING","Lille",null,"59037","France","FR",{"type":53,"coordinates":54},"Point",[55,56],3.05512,50.63391,{"lat":56,"lon":55},[59],{"name":48,"role":39,"phone":60,"phoneExt":48,"email":48},"0320445962",{"type":62,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100406534","transcutaneous-tibial-neuro-stimulation-to-improve-voiding-dysfunction-in-multiple-sclerosis-100406534",false,"NCT04573673","Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.","Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.","NEUROSTIM-SEP1","Inclusion Criteria:\n\n* Patient with a diagnosis of multiple sclerosis\n* Patient with bladder-sphincter dyssinergia\n* Patient using clean intermittent self-catheterization as exclusive bladder management\n* Patient who has given written consent\n* Socially insured patient\n* Patient willing to comply with all study procedures and study duration\n\nExclusion Criteria:\n\n* Patient with other associated neurological pathology\n* Patient with an Expanded Disability Status Scale (EDSS) score ≥ 6\n* Patient with recurrent urinary tract infections (\\> 3 episodes \u002F year)\n* Patient with uncontrolled overactive bladder\n* Patient with uncontrolled detrusor hyperactivity\n* Patient with a bladder compliance disorder\n* Patient with tibial neuro-stimulation in the last 3 months\n* Patient treated with a sacral neuro-modulation\n* Patient who has received an intradermal injection of botulinum toxin A within the last 9 -months Patient who received alpha-blocker treatment within the last month Patient with benign prostatic hypertrophy (prostate volume \\> 40 cc) - Last ultrasound scan \\\u003C 6 months.\n\nPatient with one or more bladder diverticulum(s) Patient with unilateral or bilateral renal Patient with unilateral or bilateral vesico-ureteral reflux Patient with impaired renal function (GFR according to CKD-EPI \\\u003C 60 ml\u002Fmin\u002F1.73m2) Patient with a metallic prosthesis on the lower limb Patient with a Pacemaker Pregnant patient","ALL","18 Years","65 Years",{"count":75,"type":76},68,"ESTIMATED","INTERVENTIONAL",[79],"NA","The present trial is designed to assess the efficacy and safety of transcutaneous tibial neuro-stimulation (TTNS) in improving bladder emptying in multiple sclerosis (MS) patients.\n\nPatients presenting with MS and performing clean intermittent self-catheterization (CISC) to empty the bladder in the context of voiding dysfunction, will be eligible.\n\nIncluded patients will be randomly assigned to two distinct arms\n\n* PTNS de verum : patients will be treated with transcutaneous tibial neuro-stimulation at a rate of one session of 30 consecutive minutes daily for a period of 12 weeks.\n* PTNS placebo : Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for a period of 12 weeks (same treatment regimen as the experimental group).\n\nEfficacy in improving voiding dysfunction will be assessed 12 weeks after randomization using the BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume \u002F total bladder volume.",[82,83],"Multiple Sclerosis","Lower Urinary Tract Symptoms",[85,86,87,88],"Multiple sclerosis","Voiding dysfunction","Bladder-sphincter dyssinergia","Tibial neuro-stimulation","2025-12-16",{"date":91,"type":92},"2025-12-23","ACTUAL",{"date":94,"type":92},"2021-12-01",{"date":96,"type":76},"2026-06",{"name":5,"class":6},1]