[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07686055":3,"trial-entities:NCT07686055":116,"trial-summary:NCT07686055":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":45,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":87,"locations":89,"central_contacts":108,"overall_officials":111,"references":114,"see_also_links":115},"NCT07686055","STUDY26050198","Precision Management of Urinary Tract Symptoms in Older Women","Precision Management of Urinary Tract Symptoms in Older Women: A Randomized Trial to Reduce Overtreatment","NOT_YET_RECRUITING","2027-02-14","2026-06","2026-07-07","2026-07-14","Megan Bradley","OTHER",false,"This project aims to improve the diagnosis and management of urinary tract symptoms in older women by comparing three common treatment strategies-empiric antibiotics, urinalysis-guided therapy, and culture-directed care-in a randomized trial. By integrating patient-reported outcomes, laboratory data, the study will identify which patients benefit from antibiotics and which can safely avoid them. Findings will inform precision care strategies and promote antibiotic stewardship while improving symptom outcomes and quality of life in this high-risk population.","Complete a 3-arm randomized pilot trial of either empiric, urinalysis-directed or culture-directed management for UTI symptoms in older women (≥age 65 years old) with a history of recurrent UTI. We will recruit and enroll 90 women with a history of rUTI from the University of Pittsburgh Medical Center - Women's Center for Bladder and Pelvic Health and the Pitt+Me® Research Registry. Once enrolled and randomized, women will be followed for a total of 28 days.",[19],"Urinary Tract Infection (Diagnosis)",[21,22,23],"Urinary Tract Infection","Women","Older","INTERVENTIONAL","TREATMENT",[27],"PHASE3",{"count":29,"type":30},90,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Antibiotics","Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim\u002Fsulfamethoxazole 875\u002F125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days",[37,38,39],"Culture-directed Antibiotic Treatment","Empiric (Immediate) Antibiotic Treatment","Urinalysis-directed Antibiotic Treatment",[41],{"measure":42,"description":43,"timeFrame":44},"Clinical Success at 14 Days","Score of \\\u003C1 on question 1 (urinary burning),3 (urinary urgency) and 5 (urinary frequency) on Urinary Tract Infection Symptom Assessment at day 14. A lower scale correlates with better symptoms with 0 being no symptoms and 1 being \"little\" symptoms.","14 days",[46,50,54,57],{"measure":47,"description":48,"timeFrame":49},"UTI sequelae","Proportion of those with either ED visit, pyelonephritis or sepsis within 30 days from study start","30 days",{"measure":51,"description":52,"timeFrame":53},"Positive urine cultures","Proportion of participants with positive urine cultures","5 days",{"measure":55,"description":56,"timeFrame":44},"Change from Baseline in Recurrent Urinary Tract Infection Symptom Scale Score at 14 Days","Score on the Recurrent Urinary Tract Infection Symptom Scale from baseline to 14 day follow-up. This scale has 11 questions with range from 0-10 so the total score is a sum and could range from 0 to 110 (reported as total score). Higher scores represent worse symptoms.",{"measure":58,"description":59,"timeFrame":53},"Antibiotic appropriateness of Current Therapy","Of those that received antibiotics, how many had a positive culture susceptible to the prescribed antibiotic","FEMALE","65 Years",null,{"inclusion":64,"exclusion":70,"raw_text":86},[65,66,67,68,69],"Female biologic Sex","Age ≥65 years old","History of recurrent UTI per patient report of greater than 2 UTIs in the last 6 months or 3 UTIs in the last year","Patient reported UTI defined as:","Dysuria, increased urinary urgency\u002Ffrequency and\u002For suprapubic pain",[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"Male biologic sex","Age \\\u003C65 years old","History of augmentation cystoplasty or cystectomy","Currently performing clean intermittent self-catheterization","Current indwelling foley catheter","Urinary tract instrumentation (i.e., cystourethroscopy, foley catheter placement) in the last 30 days","Undergoing treatment for malignancy","History of either confirmed or patient reported pyelonephritis and\u002For urosepsis","Cirrhosis and\u002For end stage liver disease","Chronic kidney disease with most recent estimated glomerular filtration rate \\\u003C50 ml\u002Fmin","Dementia and\u002For currently reside in skilled nursing facility","Current high-dose chronic steroids (\\>20mg\u002Fday of prednisone)","Previous solid organ transplant","Provider concern for pyelonephritis and\u002For sepsis (i.e., fevers)","Unwilling or unable to comply with study procedures (including ability to complete electronic questionnaires)","Inclusion Criteria:\n\n* Female biologic Sex\n* Age ≥65 years old\n* History of recurrent UTI per patient report of greater than 2 UTIs in the last 6 months or 3 UTIs in the last year\n* Patient reported UTI defined as:\n\n  * Dysuria, increased urinary urgency\u002Ffrequency and\u002For suprapubic pain\n\nExclusion Criteria:\n\n* Male biologic sex\n* Age \\\u003C65 years old\n* History of augmentation cystoplasty or cystectomy\n* Currently performing clean intermittent self-catheterization\n* Current indwelling foley catheter\n* Urinary tract instrumentation (i.e., cystourethroscopy, foley catheter placement) in the last 30 days\n* Undergoing treatment for malignancy\n* History of either confirmed or patient reported pyelonephritis and\u002For urosepsis\n* Cirrhosis and\u002For end stage liver disease\n* Chronic kidney disease with most recent estimated glomerular filtration rate \\\u003C50 ml\u002Fmin\n* Dementia and\u002For currently reside in skilled nursing facility\n* Current high-dose chronic steroids (\\>20mg\u002Fday of prednisone)\n* Previous solid organ transplant\n* Provider concern for pyelonephritis and\u002For sepsis (i.e., fevers)\n* Unwilling or unable to comply with study procedures (including ability to complete electronic questionnaires)",[88],"OLDER_ADULT",[90],{"facility":91,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":105},"UPMC-Magee Womens Hospital","Pittsburgh","Pennsylvania","15213","United States",[97,102],{"name":98,"role":99,"phone":100,"email":101},"Megan S Bradley, MD, MSc","CONTACT","412-641-7850","bradleym4@upmc.edu",{"name":103,"role":104},"Megan Bradley, MD, MSc","PRINCIPAL_INVESTIGATOR",{"lat":106,"lon":107},40.44062,-79.99589,[109],{"name":110,"role":99,"phone":100,"email":101},"Megan S Bradley, MD MSc",[112],{"name":103,"affiliation":113,"role":104},"University of Pittsburgh",[],[],{"nct_id":4,"conditions":117,"biomarkers":118},[21],[],{"nct_id":4,"found":120,"summary":121,"prompt_version":130},true,{"design":122,"status":123,"heading":6,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is a randomized pilot study comparing three different treatment approaches for UTI symptoms. It plans to enroll 90 women.","completed","This study is looking for women aged 65 or older who have a history of recurrent urinary tract infections (UTIs). The goal is to find the best way to treat UTI symptoms in older women. You would be randomly assigned to one of three treatment groups: receiving antibiotics right away (nitrofurantoin, trimethoprim\u002Fsulfamethoxazole, fosfomycin, ciprofloxacin, or cephalexin), receiving antibiotics based on a urine test, or receiving antibiotics based on a urine culture. Researchers will then see if your symptoms improve after 14 days. This study aims to help doctors decide when antibiotics are truly needed for UTIs in older women, improving care and reducing unnecessary antibiotic use. Enrollment is planned for 90 participants, but the current status is unclear.","Participants will be followed for 28 days after randomization, with clinical success measured at 14 days.",118,"You would be followed for a total of 28 days after being enrolled and randomized.","Not stated in the trial record.",[34],"v2"]