[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570370":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":64,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bactrim or Macrobid (single dose)","ACTIVE_COMPARATOR","Bactrim (800\u002F160mg) or Macrobid (100 mg) depending on participants' allergies",[13],"Drug: Bactrim or Macrobid",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Identical appearing placebo for a single dose",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bactrim or Macrobid","Participants will be assigned to Bactrim or Macrobid depending on participants' allergies",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Participants will be assigned to identical appearing placebo",[15],[31],{"name":32,"affiliation":5,"role":33},"Susanne Taege, MD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","614-293-4643","Susanne.Taege@osumc.edu",{"name":40,"role":36,"phone":41,"phoneExt":26,"email":42},"Shirley Dong, MD","614-293-8045","Shirley.Dong@osumc.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The Ohio State University Wexner Medical Center OB\u002FGYN Female Pelvic Medicine and Reconstructive Surgery","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-82.99879,39.96118,{"lat":56,"lon":55},[59,60,61,62],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},{"name":40,"role":36,"phone":41,"phoneExt":26,"email":42},{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"name":40,"role":63,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":33,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Susanne Taege","MD, Assistant Professor","100570370","phase-4-assessing-the-utility-of-prophylactic-antibiotics-at-time-of-urethral-bulking-using-bulkamid-bulkamid-study-100570370",false,"NCT06706362","Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)","Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid","Inclusion Criteria\n\n* Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at The Ohio State University 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-operative work-up (including either negative urine culture or urine dip negative for infection).\n* Office evaluation with evidence of SUI either with urodynamic studies (UDS) or positive cough stress test (CST).\n* Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)\n\nExclusion Criteria\n\n* Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease\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* Non-English speaking patients\n* Pregnant patients\n* Pelvic organ prolapse stage greater than 2\n* Patients with immunosuppression due to underlying medical conditions\n* Recent antibiotic treatment within one week of the procedure","FEMALE","18 Years","50 Years",{"count":78,"type":79},138,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success rates if patients require temporary indwelling catheter versus intermittent self-catheterization (ISC).",[85],"Stress Urinary Incontinence",[87,88,89,90,91],"Bulkamid","Urinary tract infections","Bactrim","Macrobid","Urethral bulking","2025-10-02",{"date":94,"type":95},"2025-10-08","ACTUAL",{"date":97,"type":95},"2025-09-15",{"date":99,"type":79},"2027-10-15",{"name":5,"class":6},1]