[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577337":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":24,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":24,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Miami","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Standard injection template followed by HD-sEMG guided injection","EXPERIMENTAL","Participants will be in this group for up to 15 months",[13,14],"Drug: Botulinum neurotoxin","Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device",{"label":16,"type":10,"description":11,"interventionNames":17},"Group B: HD-sEMG guided injection followed by standard injection template",[13,14],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Botulinum neurotoxin","Botulinum neurotoxin will be injected into the pelvic floor muscles following either a standard template (standard injection arm), or guided using high-density surface EMG (guided arm). Participants will receive this drug twice throughout the duration of the study. Approximately 200 units of botulinum neurotoxin will be administered per injection.",[9,16],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DEVICE","High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device","A personalized, precision botulinum neurotoxin injection guidance medical device, utilizing an intra-vaginal high-density surface EMG system to optimize the treatment outcomes in chronic pelvic pain (CPP) management. The device will be used five times during the study. Each use will last approximately ten minutes.",[9,16],[31],{"name":32,"affiliation":5,"role":33},"Yingchun Zhang, PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","305-284-2445","y.zhang@miami.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Miami","Florida","33136","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-80.19366,25.77427,{"lat":51,"lon":50},[54,58,59,62],{"name":55,"role":36,"phone":56,"phoneExt":24,"email":57},"Elena Cortizas, MS","305-243-3593","ecortizas@med.miami.edu",{"name":32,"role":33,"phone":24,"phoneExt":24,"email":24},{"name":60,"role":61,"phone":24,"phoneExt":24,"email":24},"Raveen Syan, MD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":24,"phoneExt":24,"email":24},"Katherine Amin, MD",{"type":33,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Yingchun Zhang","Professor",[68],{"name":69,"class":70},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100577337","phase-1-botox-for-chronic-pelvic-pain-100577337",false,"NCT06796985","Botox for Chronic Pelvic Pain","High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain","Inclusion Criteria:\n\n1. Females between 18 and 75 years of age\n2. Clinical diagnosis of chronic pelvic pain\n3. Complaints of pain, pressure, or discomfort in the bladder and\u002For pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., UTI) \\*\n4. Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers\n5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination\n6. No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment\n7. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Males\n2. Women \\\u003C 18 and \\> 76 years of age\n3. History of pelvic malignancy and sexual transmitted diseases that is currently not in remission\n4. Bleeding disorder such as coagulopathy\n5. Hypersensitivity to botulinum neurotoxin\n6. Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment\n7. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis\n8. Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.","FEMALE","18 Years","75 Years",{"count":82,"type":83},30,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.",[89],"Pelvic Floor Disorders","2026-06-15",{"date":92,"type":93},"2026-06-17","ACTUAL",{"date":95,"type":93},"2025-02-24",{"date":97,"type":83},"2027-03-22",{"name":5,"class":6},1]