[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569541":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":38,"responsibleParty":52,"collaborators":34,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":34,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":34,"enrollmentInfo":63,"targetDuration":34,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":77,"overallStatus":81,"whyStopped":34,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Louisville","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Higher volume intravesical lidocaine","ACTIVE_COMPARATOR","200 ml of 2% lidocaine without epinephrine intravesical instillation 20-30 minutes prior to bladder botox.",[13],"Drug: Lidocaine 2% without vessel constrictor",{"label":15,"type":10,"description":16,"interventionNames":17},"Lower volume intravesical lidocaine","30 ml of 2% intravesical lidocaine without epinephrine instilled into the bladder 20-30 minutes prior to bladder botox.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Lidocaine 2% without vessel constrictor","different volumes of intravesical 2% lidocaine without epinephrine, all patients will be receiving bladder botox but this will not be compared",[9,15],[25],"onabotulinum toxin",[27],{"name":28,"affiliation":5,"role":29},"Sean Francis, MD","PRINCIPAL_INVESTIGATOR",[31,36],{"name":28,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","502-588-7660",null,"laurel.carbone@louisvill.edu",{"name":37,"role":32,"phone":34,"phoneExt":34,"email":34},"Laurel Carbone, MD",[39],{"facility":40,"status":34,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":34},"University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery","Louisville","Kentucky","40202","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-85.75941,38.25424,{"lat":50,"lon":49},{"type":29,"investigatorFullName":28,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"OBGYN Department Chair","100569541","phase-4-optimal-intravesical-lidocaine-volume-for-pain-relief-during-office-intra-detrusor-onabotulinum-toxin-a-injections-100569541",false,"NCT06695585","Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections","Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections: a Prospective Randomized Superiority Trial","Inclusion Criteria:\n\n* Adult female, \\>18 years, English-speaking (surveys utilized are not validated in all languages)\n* Able to provide informed consent\n* Indications: Refractory urge urinary incontinence, Refractory urinary urgency and frequency, Neurogenic bladder (without sensory deficit)\n\nExclusion Criteria:\n\n* Untreated urinary tract infection at the time of procedure\n* Contra-indication to Botox\n* Contraindication to intravesical lidocaine\n* Inability to provide informed consent\n* Pregnancy, breast-feeding, intending to become pregnant within 6 months of treatment","FEMALE","18 Years",{"count":64,"type":65},36,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.",[71,72,73,74,75,76],"Overactive Bladder","Overactive Bladder Syndrome","Urinary Urgency","Urinary Frequency","Urge Incontinence","Neurogenic Bladder",[78,79,80],"Bladder Botox","Intravesical lidocaine","office Botox","NOT_YET_RECRUITING","2024-11-15",{"date":84,"type":85},"2024-11-19","ACTUAL",{"date":87,"type":65},"2024-12-01",{"date":89,"type":65},"2025-12-01",{"name":5,"class":6},1]