[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479137":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":18,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":18,"enrollmentInfo":78,"targetDuration":18,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Atlantic Health System","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Antibiotic arm","EXPERIMENTAL","Antibiotics will be administered for 2 days pre-treatment, on the treatment day, and 2 days post-treatment.",[13],"Drug: Nitrofurantoin",{"label":15,"type":16,"description":17,"interventionNames":18},"No treatment arm","NO_INTERVENTION","No antibiotics administered.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Nitrofurantoin","For those randomized to the treatment arm, antibiotics will be prescribed at the discretion of the ordering physician. They will be prescribed only in oral form and in accordance with the patient's allergy profile.",[9],[26,27,28,29,30,31],"Trimethoprim\u002FSulfamethoxazole","Trimethoprim","Cefalexin","Ciprofloxacin","Augmentin","Fosfomycin",[33],{"name":34,"affiliation":5,"role":35},"Carolyn Botros, DO","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":18,"email":41},"Anastasiya Holubyeva, MD","CONTACT","9739717267","anastasiya.holubyeva@atlantichealth.org",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Atlantic Health","RECRUITING","Morristown","New Jersey","07962-1905","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-74.48154,40.79677,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":18,"email":61},"Lyudmila Babaev","862-246-4973","lyudmila.babaev@atlantichealth.org",{"type":35,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Carolyn Botros","Associate Program Director FPMRS Fellowship, Principal Investigator",[66],{"name":67,"class":6},"Columbia University","100479137","phase-4-use-of-prophylactic-antibiotics-prior-to-onabotulinumtoxina-100479137",false,"NCT05519072","Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA","Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Female\n* Age ≥ 18\n* Patient undergoing bladder Botox treatment\n\nExclusion Criteria:\n\n* Pregnant and\u002For breastfeeding\n* Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or post void residual (PVR) \\> 200 mL, unwillingness or inability to initiate clean intermittent catheterization (CIC) post-treatment if required.\n* Contraindication to oral antibiotics - hypersensitivity or allergy\n* Inability to take medication by mouth",true,"FEMALE","18 Years",{"count":79,"type":80},140,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","This study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis. By proving this, the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance.\n\nParticipants will be randomized to antibiotic or no treatment arm. Those randomized to the treatment arm will receive oral antibiotics for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. Participants will return for a follow up appointment approximately 2 weeks after treatment to assess for urinary tract infection (UTI) symptoms. They will be called again at 6 weeks for follow up.",[86],"Antibiotic Prophylaxis",[88,89,90],"Antibiotics","Botox","OnabotulinumtoxinA","2024-03-25",{"date":93,"type":94},"2024-03-27","ACTUAL",{"date":96,"type":94},"2022-08-16",{"date":98,"type":80},"2024-08-16",{"name":5,"class":6},1]