[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650228":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":64,"collaborators":31,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":31,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":31,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":92,"whyStopped":31,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Far Eastern Memorial Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Education PFMT","ACTIVE_COMPARATOR","Participants receive 8 weeks of standard oral education on Pelvic Floor Muscle Training (PFMT). They are required to perform daily home-based PFMT and track their exercise frequency using a smartphone app. Clinic visits are scheduled at weeks 0, 2, 4, and 8.",[13],"Behavioral: Behavioral",{"label":15,"type":16,"description":17,"interventionNames":18},"Biofeedback-assisted PFMT","EXPERIMENTAL","Participants receive 8 weeks of biofeedback-assisted PFMT to improve muscle contraction accuracy using the Enraf-Nonius EMG-Biofeedback Unit. They also perform and track daily home-based PFMT. Clinic visits are scheduled at weeks 0, 2, 4, and 8.",[19],"Device: Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only)",{"label":21,"type":16,"description":22,"interventionNames":23},"Biofeedback PFMT + Tibial Nerve Stimulation","Participants receive 8 weeks of biofeedback-assisted PFMT combined with 30-40 minutes of tibial nerve electrical stimulation using the Enraf-Nonius unit per clinic visit. They also perform and track daily home-based PFMT. Clinic visits are scheduled at weeks 0, 2, 4, and 8.",[24],"Device: Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation)",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Behavioral","Participants receive standard oral education on Pelvic Floor Muscle Training (PFMT). They are instructed to perform daily home-based pelvic floor exercises and track their compliance and exercise frequency using a smartphone timer application. Clinical assessments and educational reinforcements are conducted at weeks 0, 2, 4, and 8.",[9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DEVICE","Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only)","Participants undergo biofeedback-assisted Pelvic Floor Muscle Training (PFMT) using the Enraf-Nonius EMG-Biofeedback Unit. During clinic visits at weeks 0, 2, 4, and 8, the device is used to assist patients in accurately identifying and contracting the correct pelvic floor muscles. In addition to clinic sessions, participants perform and track daily home-based PFMT.",[15],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation)","Participants receive biofeedback-assisted PFMT combined with percutaneous tibial nerve electrical stimulation using the Enraf-Nonius device. During clinic visits at weeks 0, 2, 4, and 8, patients receive a 30 to 40-minute session of electrical stimulation (parameters: 20 Hz, 200 μs, with intensity progressively adjusted to the maximum tolerable painless threshold). Participants also perform and track daily home-based PFMT.",[21],[42],{"name":43,"affiliation":5,"role":44},"Wen Yih Wu, MD","PRINCIPAL_INVESTIGATOR",[46,52],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Ying Ju Liu, MD","CONTACT","+886-2-89667000","4449","easoneric0416@gmail.com",{"name":43,"role":48,"phone":49,"phoneExt":53,"email":54},"1813","wenyih@gmail.com",[56],{"facility":5,"status":31,"city":57,"state":58,"zip":58,"country":58,"countryCode":59,"cosmosGeoPoint":31,"geoPoint":31,"contacts":60},"New Taipei City","Taiwan","TW",[61],{"name":62,"role":48,"phone":63,"phoneExt":53,"email":54},"Wen-Yi Wu, MD","+886-2-8966-7000",{"type":65,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100650228","treatment-efficacy-for-overactive-bladder-comparing-education-biofeedback-and-nerve-stimulation-100650228",false,"NCT07744620","Treatment Efficacy for Overactive Bladder: Comparing Education, Biofeedback, and Nerve Stimulation","Efficacy of Treatments for Overactive Bladder Based on Pathophysiological Phenotypes: A Comparison of Verbal Education, Biofeedback-Assisted Pelvic Floor Muscle Training, and Combined Tibial Nerve Stimulation","Inclusion Criteria:\n\n* Stable on chronic medications: Participants must have been on a long-term, regular regimen of routine medications for chronic conditions (e.g., hypertension, diabetes, hyperlipidemia) prior to study entry, with no expected changes in dosage or administration during the 8-week study period.\n* Diagnosed with Overactive Bladder (OAB) according to the International Continence Society (ICS) definition, including urgency, frequency, and nocturia, with or without urgency urinary incontinence (must be documented as OAB-wet or OAB-dry).\n* Symptoms persisting for at least 3 months.\n* Overactive Bladder Symptom Score (OABSS) total score ≥ 3 at baseline (Week 0), with an urgency score (Question 3) ≥ 2 (meeting the clinical threshold for core OAB symptom intensity).\n\nExclusion Criteria:\n\n* Concurrent active urinary tract infection (UTI), bladder stones, or urinary tract malignancy.\n* Inability to follow instructions for muscle training due to cognitive impairment or severe psychiatric illness.\n* Presence of implanted electronic medical devices (e.g., cardiac pacemakers) (contraindication for electrical stimulation).\n* Currently pregnant women or those planning to become pregnant during the study period.\n* Use of antimuscarinics (e.g., Oxybutynin, Tolterodine, Solifenacin) or beta-3 adrenergic receptor agonists (e.g., Mirabegron) within 2 weeks prior to study entry.\n* Receipt of pelvic or perineal physical therapy outside of this study protocol (e.g., vaginal or anal probe electrical stimulation, pelvic floor magnetic stimulation, transcutaneous microcurrent stimulation) within 2 weeks prior to study entry.\n* Receipt of intravesical Botulinum toxin (Botox) injections, sacral neuromodulation, or any surgical treatment related to urinary incontinence or pelvic organ prolapse within 2 weeks prior to study entry.","FEMALE","20 Years",{"count":76,"type":77},201,"ESTIMATED","INTERVENTIONAL",[80],"NA","The purpose of this clinical trial is to evaluate the effectiveness of different behavioral therapies and neuromodulation for treating women with idiopathic Overactive Bladder (OAB). The study aims to compare three 8-week treatment plans: oral education on Pelvic Floor Muscle Training (PFMT), biofeedback-assisted PFMT, and biofeedback-assisted PFMT combined with tibial nerve electrical stimulation using the \"Enraf-Nonius\" EMG-Biofeedback Unit. The main question it aims to answer is whether adding biofeedback and peripheral nerve stimulation provides better relief for OAB symptoms (such as urinary urgency, frequency, and nocturia) compared to standard oral education on PFMT alone. Participants will be randomly assigned to one of the three treatment groups and will track their daily pelvic floor exercises at home using a smartphone timer application. The study will also analyze whether patients with different OAB phenotypes (OAB-wet versus OAB-dry) respond differently to these treatment interventions.",[83,84],"Urinary Bladder, Overactive","Urinary Incontinence, Urge",[86,87,88,89,90,91],"Overactive Bladder (OAB)","Pelvic Floor Muscle Training (PFMT)","Biofeedback","Tibial Nerve Stimulation","Neuromodulation","Electrical Stimulation","NOT_YET_RECRUITING","2026-07-30",{"date":95,"type":96},"2026-08-04","ACTUAL",{"date":98,"type":77},"2026-08-03",{"date":100,"type":77},"2030-04-30",{"name":5,"class":6},1]