[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444090":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":57,"collaborators":61,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":92,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"HillMed Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Template Injection","ACTIVE_COMPARATOR","For the standard template injection, 200 units of BoNT diluted in 6mL of preservative saline will be prepared. 1\u002F4 of the prepared BoNT solution will be administered to each of the pubococcygeus and puborectalis muscle at 5 and 7 o'clock position, respectively. The index finger will be used for palpation as the 20-gauge spinal needle with a trumpet guide (i.e. paracervical block kit) piercing through the vaginal mucosa to the intended muscle groups. The syringe will be withdrawn before each injection to avoid intravascular injection.",[13],"Drug: Botulinum Neurotoxin",{"label":15,"type":16,"description":17,"interventionNames":18},"Guided Injection","EXPERIMENTAL","For the guided injection, pelvic floor injections (total of 4) will be made to the pubococcygeus and puborectalis muscles each, at NMJ locations (1.5 ml per site), at patient-specific locations and depths identified from vaginal HD-sEMG recordings. NMJ mappings will be generated for each participant. The channel locations will provide angle measurements for each NMJ. The device will calculate these parameters based on acquired HD-sEMG. The index finger will be used for palpation and guidance of injection needle through the vaginal mucosa to the defined injection sites. The BoNT dosage with respect to the total 200 units administered to each site will be patient specific, determined as the ratio of the resting average resting root-mean square (RMS) value of a specific region divided by the total average resting RMS.",[19,13],"Device: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"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).",[15,9],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Nicholas C Dias, PhD","CONTACT","2816581953","nickdias@hillmedgroup.com",[39],{"facility":40,"status":26,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Baylor College of Medicine","Houston","Texas","77030","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-95.36327,29.76328,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":55,"phoneExt":26,"email":56},"Christopher P Smith, MD, MBA, MSS","713-798-4001","cps@bcm.edu",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Nicholas Dias","Principal Research Scientist",[62,64],{"name":40,"class":63},"OTHER",{"name":65,"class":63},"University of Houston","100444090","early-phase-1-a-novel-medical-system-for-quantitative-diagnosis-and-personalized-precision-botulinum-neurotoxin-injection-in-chronic-pelvic-pain-management-100444090",false,"NCT05062902","A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management","An Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management","Inclusion Criteria:\n\n* Inclusion criteria for interstitial cystitis\u002Fbladder pain syndrome (IC\u002FBPS) patients will be:\n\n  1. Woman aged 18 to 60.\n  2. Have a clinical diagnosis of IC\u002FBPS.\n  3. 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., urinary tract infection).\n  4. Myofascial pain diagnosed with palpable contracted muscle fibers.\n  5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination.\n  6. Pelvic floor hypertonicity (PFH), measured using vaginal manometry (pressure \\> 35 cm∙H2O).\n  7. Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Exclusion criteria consist of the following:\n\n  1. History of pelvic malignancy and sexually transmitted diseases.\n  2. Bleeding disorder such as coagulopathy\n  3. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis.\n  4. Pregnancy, breast feeding or desiring for pregnancy in the coming year.\n  5. Subjects with history of pelvic surgery (e.g., pain from mid-urethral sling or pelvic mesh),\n  6. Pelvic malignancy (urinary tract, gynecologic, gastrointestinal)\n  7. Active fistula\n  8. Radiation cystitis\n  9. Cyclophosphamide cystitis\n  10. Pre-existing anorectal disorders\n  11. Infections near the injection sites\n  12. History of drug or alcohol abuse\n  13. Hypersensitivity to BoNT\n  14. Steroids or hormone usage will be carefully considered by the research team for inclusion.\n\nParticipants with on-going BoNT therapies will not be screened until the complete drug washout is confirmed.","FEMALE","18 Years","60 Years",{"count":77,"type":78},46,"ESTIMATED","INTERVENTIONAL",[81],"EARLY_PHASE1","The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin (BoNT) injection to treat pelvic floor muscle overactivity that complicates Chronic Pelvic Pain (CPP).",[84,85,86,87],"Interstitial Cystitis","Chronic Pain","Pelvic Floor; Relaxation","Pelvic Floor Disorders",[89,90,91],"hypertonicity","chronic pelvic pain","electromyography","NOT_YET_RECRUITING","2025-08-14",{"date":95,"type":96},"2025-08-19","ACTUAL",{"date":98,"type":78},"2025-09-15",{"date":100,"type":78},"2027-12-01",{"name":5,"class":6},1]