[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607063":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":34,"locations":43,"responsibleParty":63,"collaborators":23,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":23,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"group 1: electrical stimulation of acupuncture points plus routine care","EXPERIMENTAL","Intervention is electrical stimulation of two acupuncture points at the inner ankle of the foot over the posterior tibialis nerve, stimulation twice daily over 5 weeks",[13],"Device: group 1: electrical stimulation of acupuncture points plus routine care",{"label":15,"type":10,"description":16,"interventionNames":17},"group 2: acupressure plus routine care","manual stimulation of the same two acupressure points over the inner ankle, stimulation twice daily over 5 weeks",[18],"Other: group 2: acupressure plus routine care",{"label":20,"type":21,"description":22,"interventionNames":23},"group 3: routine care alone","NO_INTERVENTION","waiting list control",null,[25,31],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","The acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min electrical stimulation per foot with 10Hz and an intensity up to individual tolerance level.",[9],[30],"posterior tibial nerve stimulation",{"type":6,"name":15,"description":32,"armGroupLabels":33,"otherNames":23},"The acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min massage per foot",[15],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":23,"email":39},"Benno Brinkhaus, PhD, MD","CONTACT","+49 30 450 529 002","benno.brinkhaus@charite.de",{"name":41,"role":37,"phone":38,"phoneExt":23,"email":42},"Joanna Dietzel, MD","joanna.dietzel@charite.de",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin","RECRUITING","Berlin","State of Berlin","10117","Germany","DE",{"type":53,"coordinates":54},"Point",[55,56],13.41053,52.52437,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":61,"phoneExt":23,"email":62},"Schönberg Mechthild, study nurse","+49 30 450 529 027","mechthild.schoenberg@charite.de",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Benno Brinkhaus","Professor Dr. Benno Brinkhaus","100607063","stimulation-of-acupuncture-points-in-female-patients-with-multiple-sclerosis-and-neurogenic-bladder-dysfunction-100607063",false,"NCT07183683","Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction","Electrical Versus Manual Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction - A Pragmatic, Exploratory, Three-Arm, Randomized Controlled Trial Using a Mixed Methods Approach","ACULUTS","Inclusion Criteria:\n\n* Female patients, aged 18-60 years, with relapsing-remitting multiple sclerosis (RRMS) and an Expanded Disability Status Scale (EDSS) score ≤ 6\n* Stable immunomodulatory MS therapy for at least 3 months prior to enrollment\n* Presence of at least 3 out of the following 6 criteria indicative of overactive bladder dysfunction: urgency, daytime urinary frequency \\>10 times, nocturia \\>1 time per night, post-void dribbling, incontinence, or delayed initiation of micturition\n* Participants must be willing and cognitively and linguistically capable of adhering to the study protocol, performing the study interventions, and completing the required study documentation\n* Capacity to provide informed consent, and provision of written consent for both written and electronic data collection and participation in the study\n\nExclusion Criteria:\n\n* Acute MS relapse within the last 3 months prior to individual study entry\n* Planned change in immunomodulatory therapy during the study period\n* Current need for regular self-catheterization (more than twice per week)\n* Clinically relevant post-void residual volume, confirmed by ultrasound (\\>100 mL or \\>40% of pre-void volume)\n* Current or past history of bladder cancer\n* Implanted defibrillator or other pacemaker\n* Urogenital causes of bladder dysfunction, such as stress urinary incontinence or bladder prolapse\n* Spinal trauma within 5 years prior to study entry or any other pre-existing central nervous system disorders (e.g., stroke, Parkinson's disease), or history of pelvic, spinal, or bladder surgery\n* Acute urinary tract infection at the time of screening or within the previous 4 weeks\n* Urolithiasis or urogenital tumors within the past 6 months\n* Previous electrical posterior tibial nerve stimulation (TNS), acupuncture, or acupressure in the same anatomical region within 3 months prior to study entry\n* Regular pelvic floor training (more than twice per week) in the past 6 weeks or planned during the study period\n* Planned participation in another interventional clinical trial during the study period\n* Open wounds, edema, or lymphedema in the lower leg that may interfere with local intervention\n* Other serious pre-existing conditions (e.g., active cancer, heart failure, epilepsy, etc.) that contraindicate participation in the study\n* Obesity, defined as BMI \\> 30\n* Pregnancy or breastfeeding","FEMALE","18 Years","60 Years",{"count":79,"type":80},150,"ESTIMATED","INTERVENTIONAL",[83],"NA","Electrical vs. manual stimulation: The study compares two types of acupuncture - one using mild electrical currents and one using just manual no-needle techniques in the treatment of urinary bladder disfunction.\n\nThe study focuses on women diagnosed with multiple sclerosis (MS) who also have neurogenic bladder dysfunction - a condition where the bladder doesn't work properly due to nerve damage.",[86],"Neurogenic Bladder Dysfunction",[88,89,90,91,92,93],"multiple sclerosis","urinary bladder dysfunction","electrical stimulation","acupressure","acupuncture","posterior tibial nerve","2025-09-18",{"date":96,"type":97},"2025-09-19","ACTUAL",{"date":99,"type":80},"2025-09",{"date":101,"type":80},"2027-04-30",{"name":5,"class":6},1]