[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636290":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":61,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Kaohsiung Medical University Chung-Ho Memorial Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LiESWT Group","EXPERIMENTAL","Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region.",[13],"Device: Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Control Group","SHAM_COMPARATOR","Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy.",[19],"Device: Sham Shock Wave Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)","LiESWT is delivered using a focused shock wave device at an energy flux density of 0.25 mJ\u002Fmm², frequency of 3 Hz, and 3,000 pulses per session.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Shock Wave Therapy","The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.",[15],[32],{"name":33,"affiliation":34,"role":35},"Yung-Chin Lee, MD,PHD","Kaohsiung Medical University","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"JIUNHUNG GENG, MD","CONTACT","+88673121101 ext.6694","u9001090@hotmail.com",{"name":43,"role":39,"phone":40,"phoneExt":26,"email":44},"Yung-Chin Lee, MD, PHD","leeyc12345@yahoo.com.tw",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":50,"countryCode":52,"cosmosGeoPoint":26,"geoPoint":26,"contacts":53},"Kaohsiung medical university","RECRUITING","Kaohsiung","Taiwan","807","TW",[54,56,58],{"name":38,"role":39,"phone":55,"phoneExt":26,"email":41},"+88673121101 ext 6694",{"name":33,"role":39,"phone":57,"phoneExt":26,"email":44},"+88673121101",{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Jiun-Hung Geng, MD","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","KMUHIRB-F(I)-20230051","Principal Investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital","100636290","low-energy-shock-wave-therapy-for-overactive-bladder-in-women-with-metabolic-syndrome-100636290",false,"NCT07563764","Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome","A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome","Inclusion:\n\n* Female participants aged 20 to 75 years\n* Diagnosed with overactive bladder (OAB), defined as urinary frequency (≥8 times\u002Fday), nocturia (≥2 times\u002Fnight), and urgency (≥2 episodes\u002Fweek) for at least 3 months\n* Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria:\n* Waist circumference ≥80 cm\n* Blood pressure ≥130\u002F85 mmHg or receiving antihypertensive treatment\n* Fasting glucose ≥100 mg\u002FdL or receiving treatment for diabetes\n* Triglycerides ≥150 mg\u002FdL or receiving lipid-lowering treatment\n* High-density lipoprotein cholesterol \\\u003C50 mg\u002FdL\n* No pharmacological or injection treatment for OAB within 3 months prior to enrollment\n* Able to understand and comply with study procedures and questionnaires\n* Willing to provide informed consent\n\nExclusion:\n\n* History of kidney stones or bladder stones\n* Urinary tract infection within 3 months prior to enrollment or recurrent urinary tract infections (≥3 episodes)\n* Lower urinary tract surgery within 6 months prior to enrollment\n* Known or suspected malignancy of the urinary tract\n* Significant bladder outlet obstruction\n* Severe coagulopathy, liver failure, or renal failure\n* Prior pelvic malignancy or pelvic radiation therapy\n* Intravesical injection or electrical stimulation therapy within the past year\n* Substance abuse (drug or alcohol) within the past year\n* Chronic pelvic pain due to other causes\n* Inability to complete study questionnaires or procedures","FEMALE","20 Years","75 Years",{"count":76,"type":77},60,"ESTIMATED","INTERVENTIONAL",[80],"NA","Overactive bladder (OAB) is a common condition that causes urinary urgency, frequent urination, and nocturia, which can significantly affect quality of life. Women with metabolic syndrome may have a higher risk of OAB due to vascular and metabolic abnormalities.\n\nThis study aims to evaluate the effectiveness and safety of low-energy extracorporeal shock wave therapy (LiESWT), a non-invasive treatment, in women with metabolic syndrome-associated OAB. Participants will be randomly assigned to receive either active LiESWT treatment or a sham (inactive) procedure.\n\nSymptoms and treatment outcomes will be assessed using validated questionnaires, including the Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire (ICIQ-SF), Urinary Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7), as well as a voiding diary and uroflow measurements.\n\nThe results of this study may help determine whether LiESWT is an effective treatment option for improving OAB symptoms in this patient population.",[83,84,85,86,87],"Bladder","Lower Urinary Track Symptoms","Metabolic Syndrome","Urgency-Frequency","Bladder, Overactive",[89,90,91,92,93,94,95,96],"Low-energy extracorporeal shock wave therapy","LiESWT","Overactive bladder","Metabolic syndrome","Urinary urgency","Urinary frequency","Nocturia","Randomized controlled trial","2026-04-30",{"date":99,"type":100},"2026-05-04","ACTUAL",{"date":102,"type":100},"2025-02-10",{"date":104,"type":77},"2026-06-30",{"name":63,"class":6},1]