[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631468":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":71,"collaborators":18,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":18,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":18,"enrollmentInfo":83,"targetDuration":18,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":18,"overallStatus":47,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Miami","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylactic Antibiotic Group","EXPERIMENTAL","Participants in this group will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim), Keflex (500 mg cephalexin), Cipro (250 mg ciprofloxacin), or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of standard of care clinic-based urethral bulking procedure.",[13],"Drug: Bactrim (800\u002F160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)",{"label":15,"type":16,"description":17,"interventionNames":18},"No Prophylactic Antibiotic Group","NO_INTERVENTION","Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Bactrim (800\u002F160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)","Participants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim), Keflex (500 mg cephalexin), Cipro (250 mg ciprofloxacin), or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of the urethral bulking procedure.",[9],[26,27,28,29,30],"Sulfamethoxazole","Trimethoprim","Nitrofurantoin","Cephalexin","Ciprofloxacin",[32],{"name":33,"affiliation":5,"role":34},"Katherine Amin, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":18,"email":39},"CONTACT","(305) 243-6590","katherine.amin@med.miami.edu",{"name":41,"role":37,"phone":42,"phoneExt":18,"email":43},"Elena Cortizas, MS","(305) 243-3593","ecortizas@med.miami.edu",[45,62],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Desai Sethi Urology Institute","RECRUITING","Miami","Florida","33136","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-80.19366,25.77427,{"lat":57,"lon":56},[60,61],{"name":41,"role":37,"phone":42,"phoneExt":18,"email":43},{"name":33,"role":34,"phone":18,"phoneExt":18,"email":18},{"facility":63,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"University of Miami Hospitals and Clinics",{"type":54,"coordinates":65},[56,57],{"lat":57,"lon":56},[68,70],{"name":41,"role":37,"phone":69,"phoneExt":18,"email":18},"305-243-3593",{"name":33,"role":34,"phone":18,"phoneExt":18,"email":18},{"type":34,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Katherine Amin","Assistant Professor of Clinical Urology","100631468","phase-4-prophylactic-antibiotics-for-outpatient-urethral-bulking-100631468",false,"NCT07501065","Prophylactic Antibiotics for Outpatient Urethral Bulking","Prophylactic Antibiotics for Outpatient Urethral Bulking: Impact on Post-Procedural Urinary Tract Infection Rates","Inclusion Criteria:\n\n* Women ≥ 18 years of age.\n* Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at the University of Miami with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant).\n* Negative testing for UTI in pre-procedural work-up, including either negative urine culture or urine dip negative for infection (infection is defined as the presence of nitrites and\u002For pyuria with \\>1+ leukocyte esterase on dipstick or \\>5 WBC\u002FHPF).\n* Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan) before the procedure\n* Fluent in English or Spanish\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease (GFR \\\u003C30)\n* Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly that also involve insertion \\[KB2.1\\]of a foreign object\n* Recurrent UTIs, defined as 3 or more UTIs within the past 12 months or 2 UTIs within the past 6 months\n* Patients currently taking daily antibiotic prophylaxis for any reason\n* Patients with immunosuppression due to underlying medical conditions\n* Patients who are pregnant\n* Recent antibiotic treatment within one week of the procedure\n* Unable or unwilling to provide informed consent or complete study procedures","FEMALE","18 Years",{"count":84,"type":85},150,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).",[91,92,93],"Urinary Tract Infections","Stress Urinary Incontinence","Urinary Incontinence","2026-08-18",{"date":96,"type":97},"2026-08-20","ACTUAL",{"date":99,"type":85},"2026-08",{"date":101,"type":85},"2028-12",{"name":5,"class":6},2]