[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642531":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":60,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standing Prescription (Self-Start) + Sterile Urine Cup + Standing Lab Order for Urine Culture","ACTIVE_COMPARATOR","Following the procedure, subjects will receive a standing prescription for oral Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant\u002Fallergic), a sterile urine cup and standing lab orders for urine culture and discharge instructions.\n\nSuitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim\u002FSulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections.",[13],"Drug: Macrobid® Capsules 100 mg",{"label":15,"type":6,"description":16,"interventionNames":17},"Standard Triage Line; Standard Medical Care (SMC)","Subjects will receive standard post-procedure discharge instructions which typically instruct participants to follow routine practice if a UTI is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation\u002Ftreatment at an Urgent Care\u002FClinic.",[18],"Other: Standard Medical Care (SMC)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Macrobid® Capsules 100 mg","Subjects will receive Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant\u002Fallergic), a sterile urine cup and standing lab orders for urine culture.\n\nSuitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim\u002FSulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Medical Care (SMC)","Subjects will receive standard of care post-procedure discharge instructions which instruct the following if a urinary tract infection is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation\u002Ftreatment at an Urgent Care\u002FClinic.",[15],[31],{"name":32,"affiliation":5,"role":33},"Shannon Wallace, MD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Ugochukwu Okoroafor, MD","CONTACT","440-799-7739","okoroau@ccf.org",{"name":32,"role":37,"phone":41,"phoneExt":25,"email":42},"216-444-6878","wallacs8@ccf.org",[44],{"facility":45,"status":25,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Cleveland Clinic","Cleveland","Ohio","44195","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-81.69541,41.4995,{"lat":55,"lon":54},[58,59],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":61,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100642531","early-phase-1-self-start-triage-model-for-post-botox-lower-urinary-tract-symptoms-100642531",false,"NCT07648290","Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms","Inclusion Criteria:\n\n* Female patients of all races and ethnicities aged 18 years and older.\n* Diagnosis of Overactive Bladder (OAB) and\u002For Urge Urinary Incontinence (UUI).\n* Scheduled to receive intradetrusor onabotulinumtoxinA (Botox®) for symptom management.\n* Has decision making capacity to provide informed consent and comply with and follow study protocols.\n* Ability to navigate a computer system independently\n* Access to MyChart and email account\n\nExclusion Criteria:\n\n* Patients who currently perform Clean Intermittent Catheterization (CIC) or have an indwelling catheter.\n* History of Severe Renal Impairment Cr\u002FCl - \\\u003C60 ml\u002Fmin 1.73m2\n* History of recurrent UTIs (defined as \\>3x symptomatic UTIs in 12 months).\n* Post-Void Residual (PVR) volume \\>150 mL.\n* Active UTI at the time of procedure (procedure cancellation criteria).\n* Patients currently on prophylactic antibiotics.\n* Inability to provide informed consent.","FEMALE","18 Years",{"count":71,"type":72},260,"ESTIMATED","INTERVENTIONAL",[75],"EARLY_PHASE1","The primary objective of this study is to investigate whether providing a standing, take-home prescription for empiric Macrobid (self-start model) is superior to standard call-in\u002Furgent care triage (triage model) among patients undergoing intradetrusor Botox®. Urinary tract infections. (UTIs) are the most common complication with intradetrusor Botox®, and patients have to call in to the triage line or present to a health care facility to be evaluated. Thus, the research team will compare Unplanned Healthcare Utilization, i.e. the frequency of triage calls, MyChart messages, Urgent Care visits, and Emergency Department visits related to urinary symptoms, between participants in the self-start intervention group and those in the triage control group. The team hypothesizes that patients in the \"self-start\" intervention group will demonstrate a lower frequency of healthcare utilization events when compared to those in the standard of care control.",[78],"Overactive Bladder","NOT_YET_RECRUITING","2026-06-22",{"date":82,"type":83},"2026-06-25","ACTUAL",{"date":85,"type":72},"2026-07-01",{"date":87,"type":72},"2028-03-31",{"name":5,"class":6},1]