[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585809":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":86,"collaborators":89,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":17,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":17,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":66,"whyStopped":17,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nitrofurantoin (NF) daily antibiotic prophylaxis","ACTIVE_COMPARATOR","Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.",[13],"Drug: Nitrofurantoin (NF)",{"label":15,"type":16,"description":17,"interventionNames":18},"Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF)","EXPERIMENTAL",null,[19,13],"Procedure: Electrofulguration (EF)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Electrofulguration (EF)","Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.",[15],[27],"fulguration",{"type":29,"name":30,"description":11,"armGroupLabels":31,"otherNames":17},"DRUG","Nitrofurantoin (NF)",[9,15],[33],{"name":34,"affiliation":5,"role":35},"Philippe Zimmern, M.D.","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":17,"email":41},"Meghan Leak","CONTACT","214-645-8787","utswuti@utsouthwestern.edu",{"name":34,"role":39,"phone":17,"phoneExt":17,"email":17},[44,64],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The University of Kansas","NOT_YET_RECRUITING","Kansas City","Kansas","66160","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-94.62746,39.11417,{"lat":56,"lon":55},[59,63],{"name":60,"role":39,"phone":61,"phoneExt":17,"email":62},"Colby Souders, MD","913-588-6146","csouders@kumc.edu",{"name":60,"role":35,"phone":17,"phoneExt":17,"email":17},{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":50,"countryCode":51,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390",{"type":53,"coordinates":71},[72,73],-96.80667,32.78306,{"lat":73,"lon":72},[76,79,82,84],{"name":77,"role":39,"phone":40,"phoneExt":17,"email":78},"Meghan B Leak","meghan.leak@utsouthwestern.edu",{"name":80,"role":39,"phone":40,"phoneExt":17,"email":81},"Jessica de Araujo Paula","jessica.dearaujopaula@utsouthwestern.edu",{"name":83,"role":35,"phone":17,"phoneExt":17,"email":17},"Philippe Zimmern, MS",{"name":60,"role":85,"phone":17,"phoneExt":17,"email":17},"SUB_INVESTIGATOR",{"type":35,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Philippe Zimmern","Professor of Urology",[90,92,95],{"name":91,"class":6},"University of Texas",{"name":93,"class":94},"National Institutes of Health (NIH)","NIH",{"name":96,"class":94},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","100585809","phase-1-daily-nitrofurantoin-versus-bladder-fulguration-plus-daily-nitrofurantoin-for-women-with-recurrent-urinary-tract-infections-100585809",false,"NCT06907199","Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections","A Multicentric Randomized Trial of Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for the Long-term Management of Cystitis in Women With Recurrent Urinary Tract Infections","Inclusion Criteria:\n\n* Females 18 to 85 years old with at least a 1-year history of culture documented uncomplicated rUTI.\n* Diagnosis of rUTI, defined as ≥ 3 symptomatic UTIs in 12 months or ≥ 2 in 6 months.\n* Currently free from a UTI determined based on absence of symptoms as determined by the UTI symptom assessment questionnaire and negative urine culture (\\\u003C10\\^3 colony forming units per ml of urine).\n* A negative upper and lower urinary tract evaluation, including pelvic examination for pelvic organ prolapse (less than or equal to stage 2), measurement of post-void residual (less than 50 ml), and imaging (which may include renal ultrasound and standing voiding cystourethrogram) to exclude kidney stone, hydronephrosis, reflux, or urethral diverticulum.\n* Office cystoscopy documenting stages 1 or 2 of chronic cystitis.\n* Likely to stay in the geographic region for the duration of the study.\n* ASA class II or less.\n\nExclusion Criteria:\n\n* Patients on antibiotics at baseline (i.e., suppressive therapy or antibiotic therapy for non-urinary infections).\n* Patients on self-start therapy (i.e., taking antibiotics upon start of urinary symptoms concerning for UTI).\n* Patients on prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start in the next 12 months.\n* Complicated UTIs, including neurogenic bladder condition (i.e., multiple sclerosis, Parkinson's disease, spinal cord injury), bladder augmentation, or urinary diversion.\n* Patients with urinary catheters (including indwelling Foley, intermittent catheterization, and suprapubic catheters).\n* Uncontrolled diabetes (HbA1c \\>9).\n* Pregnancy\n* Allergy or resistance to Nitrofurantoin.\n* Chronic lung or liver condition precluding the use of Nitrofurantoin, including abnormal chest X ray or elevated liver function tests.\n* Chronic renal insufficiency (creatinine over 1.5 g\u002Fdl or GFR less than 40) precluding the use of Nitrofurantoin.\n* History of chronic diarrhea requiring regular therapy.\n* Patients with psychosis, dementia, swallowing disorders, or any other ability to take Nitrofurantoin reliably at home.\n* BMI over 40.\n* Use of Uromune or other vaccine approaches to reduce rUTI episodes\n* Participation in a research study involving an investigational product in the past 12 weeks.\n* Patients receiving phage therapy.\n* Current diagnosis of interstitial cystitis.\n* Patients with medical conditions requiring excessively large amounts of fluid intake.","FEMALE","18 Years","85 Years",{"count":108,"type":109},104,"ESTIMATED","INTERVENTIONAL",[112],"PHASE1","The goal of this clinical trial is to learn if the drug Nitrofurantoin (NF) taken as a daily antibiotic, works to treat cystitis compared to electrofulguration (EF) and Nitrofurantoin (NF) daily antibiotic.",[115,116],"Recurrent UTIs","Cystitis Recurrent",[118,119,120,121,122],"bladder fulguration","Nitrofurantoin","long-term managenent of cystitis","Recurrent UTI","chronic UTI","2026-04-27",{"date":125,"type":126},"2026-05-01","ACTUAL",{"date":128,"type":126},"2026-04-06",{"date":130,"type":109},"2029-01-30",{"name":5,"class":6},2]