[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631468":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":68,"collaborators":18,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":18,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":18,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":18,"overallStatus":91,"whyStopped":18,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"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) 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) 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) or Macrobid (100mg)","Participants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) 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],"Sulfamethoxazole","Trimethoprim","Nitrofurantoin",[30],{"name":31,"affiliation":5,"role":32},"Katherine Amin, MD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":18,"email":37},"CONTACT","(305) 243-6590","katherine.amin@med.miami.edu",{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},"Elena Cortizas, MS","(305) 243-3593","ecortizas@med.miami.edu",[43,59],{"facility":44,"status":18,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Desai Sethi Urology Institute","Miami","Florida","33136","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-80.19366,25.77427,{"lat":54,"lon":53},[57,58],{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},{"name":31,"role":32,"phone":18,"phoneExt":18,"email":18},{"facility":60,"status":18,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"University of Miami Hospitals and Clinics",{"type":51,"coordinates":62},[53,54],{"lat":54,"lon":53},[65,67],{"name":39,"role":35,"phone":66,"phoneExt":18,"email":18},"305-243-3593",{"name":31,"role":32,"phone":18,"phoneExt":18,"email":18},{"type":32,"investigatorFullName":69,"investigatorTitle":70,"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).\n* Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)\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\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* Pelvic organ prolapse stage greater than 2\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":81,"type":82},150,"ESTIMATED","INTERVENTIONAL",[85],"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).",[88,89,90],"Urinary Tract Infections","Stress Urinary Incontinence","Urinary Incontinence","NOT_YET_RECRUITING","2026-03-24",{"date":94,"type":95},"2026-03-30","ACTUAL",{"date":97,"type":82},"2026-06",{"date":99,"type":82},"2028-12",{"name":5,"class":6},2]