[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385978":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":88,"collaborators":91,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":35,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":35,"enrollmentInfo":103,"targetDuration":35,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":117,"overallStatus":43,"whyStopped":35,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University of South Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"5 Injections","EXPERIMENTAL","Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units\u002F10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 5 injections of 2 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder.",[13],"Drug: OnabotulinumtoxinA 100 UNT",{"label":15,"type":16,"description":17,"interventionNames":18},"20 Injections","ACTIVE_COMPARATOR","Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units\u002F10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 20 injections of 0.5 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","OnabotulinumtoxinA 100 UNT","Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.",[15,9],[26],"BOTOX",[28],{"name":29,"affiliation":5,"role":30},"Eric S Chang, MD","PRINCIPAL_INVESTIGATOR",[32,37],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","813-259-8500",null,"ericchang@usf.edu",{"name":38,"role":33,"phone":34,"phoneExt":35,"email":39},"Allison Wyman, MD","awyman@usf.edu",[41,65],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"MedStar Washington Hospital Center","RECRUITING","Washington D.C.","District of Columbia","20010","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-77.03637,38.89511,{"lat":53,"lon":52},[56,59,62,64],{"name":57,"role":33,"phone":35,"phoneExt":35,"email":58},"Nancy Ringel, MD","nringel@gmail.com",{"name":60,"role":61,"phone":35,"phoneExt":35,"email":35},"Amy Park, MD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":35,"phoneExt":35,"email":35},"Cheryl Iglesia, MD",{"name":57,"role":30,"phone":35,"phoneExt":35,"email":35},{"facility":66,"status":43,"city":67,"state":68,"zip":69,"country":47,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of South Florida Health South Tampa Center for Advanced Healthcare","Tampa","Florida","33606",{"type":50,"coordinates":71},[72,73],-82.45843,27.94752,{"lat":73,"lon":72},[76,77,78,80,82,84,86,87],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},{"name":38,"role":33,"phone":34,"phoneExt":35,"email":39},{"name":79,"role":61,"phone":35,"phoneExt":35,"email":35},"Isabel Prieto, MD",{"name":81,"role":61,"phone":35,"phoneExt":35,"email":35},"Ryan Hidalgo, MD",{"name":83,"role":61,"phone":35,"phoneExt":35,"email":35},"Renee Bassaly, DO",{"name":85,"role":61,"phone":35,"phoneExt":35,"email":35},"Kristie Greene, MD",{"name":38,"role":61,"phone":35,"phoneExt":35,"email":35},{"name":29,"role":30,"phone":35,"phoneExt":35,"email":35},{"type":30,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Eric Chang","Fellow Physician",[92],{"name":93,"class":6},"Medstar Health Research Institute","100385978","phase-4-post-procedural-pain-associated-with-5-versus-20-intravesical-injections-of-onabotulinumtoxin-a-100385978",false,"NCT04305743","Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A","Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial","Inclusion Criteria:\n\n* Women \\>=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder.\n* Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia.\n\nExclusion Criteria:\n\n* Male gender.\n* Women \\\u003C18 years of age.\n* Non-English speaking.\n* Pregnancy (patient will self-report pregnancy).\n* Participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)\n* Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence.\n* Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy.\n* Participant has a known allergy or sensitivity to any botulinum toxin preparation.\n* Participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.\n* Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.","FEMALE","18 Years",{"count":104,"type":105},60,"ESTIMATED","INTERVENTIONAL",[108],"PHASE4","Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.",[111,112,113,114,115,116],"Urinary Bladder, Overactive","Incontinence, Urge","Incontinence, Urinary","Urinary Urge Incontinence","Urinary Frequency More Than Once at Night","Nocturia",[118,119,120,121,122],"overactive bladder","urgency urinary incontinence","onabotulinumtoxin","bladder","botox","2020-11-03",{"date":125,"type":126},"2020-11-05","ACTUAL",{"date":128,"type":126},"2019-10-09",{"date":130,"type":105},"2021-06-01",{"name":5,"class":6},2]