[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559008":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":45,"studyPopulation":45,"armGroups":52,"interventions":70,"overallOfficials":45,"centralContacts":84,"locations":45,"responsibleParty":90,"collaborators":45,"id":94,"slug":45,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":45,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":45,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":45,"overallStatus":112,"whyStopped":45,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":45},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Average Daily Urination Frequency Compared to Baseline","At the end of Weeks 4, 8, and 12, the change in average daily urination frequency compared to baseline will be calculated using the participants' 72-hour voiding diaries","treatment during 12 weeks : assessments at weeks 4, 8, and 12.",[14,17,20,23,26,29,32,35,38,41],{"measure":15,"description":16,"timeFrame":12},"Average Urinary Urgency Score","At the end of Weeks 4, 8, and 12, the average urinary urgency score will be calculated using the participants' 72-hour voiding diaries",{"measure":18,"description":19,"timeFrame":12},"Average Daily Nocturia Frequency Compared to Baseline","At the end of Weeks 4, 8, and 12, the change in average daily nocturia frequency compared to baseline will be calculated using the participants' 72-hour voiding diaries",{"measure":21,"description":22,"timeFrame":12},"Average Voided Volume per Urination Compared to Baseline","At the end of Weeks 4, 8, and 12, the change in average voided volume per urination compared to baseline will be calculated using the participants' 72-hour voiding diaries",{"measure":24,"description":25,"timeFrame":12},"Average Daily Incontinence Episodes","At the end of Weeks 4, 8, and 12, the average daily incontinence episodes will be calculated using the participants' 72-hour voiding diaries",{"measure":27,"description":28,"timeFrame":12},"OABSS Compared to Baseline","At the end of Weeks 4, 8, and 12, the change in Overactive Bladder Symptom Score (OABSS) compared to baseline will be calculated.",{"measure":30,"description":31,"timeFrame":12},"PPBC-S Compared to Baseline","At the end of Weeks 4, 8, and 12, the change in Patient Perception of Bladder C Scale (PPBC-S) compared to baseline will be calculated.",{"measure":33,"description":34,"timeFrame":12},"AUA-SI-QOL Compared to Baseline","At the end of Weeks 4, 8, and 12, the change in American Urological Association- Symptom Index-Quality of life (AUA-SI-QOL) compared to baseline will be calculated.",{"measure":36,"description":37,"timeFrame":12},"SAS Compared to Baseline","At the end of Weeks 4, 8, and 12, the change in Self-Rating Anxiety Scale (SAS) compared to baseline will be calculated.",{"measure":39,"description":40,"timeFrame":12},"Participant Satisfaction","At the end of Weeks 4, 8, and 12, participant satisfaction will be assessed using a participant satisfaction questionnaire",{"measure":42,"description":43,"timeFrame":44},"Potential Adverse Events Related by TTNS","During the study, information on potential adverse events related to TTNS will be recorded, including pain and infection at the stimulation site, tibial nerve injury (such as motor dysfunction, neuralgia, etc.), urinary system complications (such as urinary retention), and other adverse events that the investigator deems potentially related to TTNS.\"","Entire Study",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":49,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":51,"maskingDescription":45,"whoMasked":45},"NONE",[53,59,64],{"label":54,"type":55,"description":56,"interventionNames":57},"Combination Therapy","EXPERIMENTAL","Approximately 30 participants are expected to be enrolled, and they will receive a combination of standard medication and TTNS therapy for 12 weeks.",[58],"Combination Product: Combination Therapy",{"label":60,"type":55,"description":61,"interventionNames":62},"TTNS","Approximately 30 participants are expected to be enrolled, and they will receive TTNS therapy for 12 weeks.",[63],"Device: Transcutaneous Tibial Nerve Stimulation(TTNS)",{"label":65,"type":66,"description":67,"interventionNames":68},"Standard Medication Therapy","ACTIVE_COMPARATOR","Approximately 30 participants are expected to be enrolled, and they will receive standard medication and TTNS therapy for 12 weeks.",[69],"Drug: Standard Medication Therapy",[71,76,80],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":45},"DEVICE","Transcutaneous Tibial Nerve Stimulation(TTNS)","Participants in this group will discontinue all relevant medications (e.g., β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs) at least 14 days before signing the informed consent and will not use these medications during the study period. They will receive treatment solely with wearable transcutaneous tibial nerve stimulation.",[60],{"type":77,"name":54,"description":78,"armGroupLabels":79,"otherNames":45},"COMBINATION_PRODUCT","Participants in this group will continue their prescribed medication regimen, which may include β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs, with dosages and administration unchanged throughout the study. In addition to the standard medication therapy, participants will receive wearable transcutaneous tibial nerve stimulation using a wearable device",[54],{"type":81,"name":65,"description":82,"armGroupLabels":83,"otherNames":45},"DRUG","Participants in this group will maintain their usual medication regimen, which may include β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs, with dosages and administration remaining consistent throughout the study. No additional interventions will be provided.",[65],[85],{"name":86,"role":87,"phone":88,"phoneExt":45,"email":89},"Qing Quan","CONTACT","86+18910980422","Qyuanmd@outlook.com",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"SPONSOR_INVESTIGATOR","Qing Yuan","Associate Chief Physician of Urology","100559008",false,"NCT06558539","Tibial Nerve Stimulation for Post-BPH Overactive Bladder","Study on the Efficacy of Wearable Transcutaneous Tibial Nerve Stimulation for Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery","Inclusion Criteria:\n\n* 1\\. Patients with overactive bladder before benign prostatic hyperplasia 2.Overactive bladder still exists 1 month after the operation of benign prostatic hyperplasia; 3.50 ≤ age ≤80 , male 4.72-hour urination diary showed an average of ≥8 urination times every 24 hours at baseline\n\nExclusion Criteria:\n\n\\-","MALE","50 Years","80 Years",{"count":104,"type":105},90,"ESTIMATED","INTERVENTIONAL",[108],"PHASE3","A single-center, randomized, parallel-controlled design. Approximately 90 cases of persistent overactive bladder symptoms post benign prostatic hyperplasia surgery are expected to be enrolled. The study participants will be randomly assigned to three groups, with 30 participants in each group.",[111],"Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery","NOT_YET_RECRUITING","2024-08-14",{"date":115,"type":116},"2024-08-16","ACTUAL",{"date":118,"type":105},"2024-09",{"date":120,"type":105},"2025-02",{"name":92,"class":6}]