Urinary Tract Infection (Diagnosis)
Conditions
Keywords
Urinary Tract Infection, Women, Older
Brief summary
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.
Detailed description
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.
Interventions
DRUGAntibiotics
Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 875/125 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
Sponsors
Megan Bradley
American Association of Obstetricians and Gynecologists Foundation (AAOGF)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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/frequency and/or suprapubic pain
Exclusion criteria
* Male biologic sex * Age \<65 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/or urosepsis * Cirrhosis and/or end stage liver disease * Chronic kidney disease with most recent estimated glomerular filtration rate \<50 ml/min * Dementia and/or currently reside in skilled nursing facility * Current high-dose chronic steroids (\>20mg/day of prednisone) * Previous solid organ transplant * Provider concern for pyelonephritis and/or sepsis (i.e., fevers) * Unwilling or unable to comply with study procedures (including ability to complete electronic questionnaires)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success at 14 Days | 14 days | Score of \<1 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UTI sequelae | 30 days | Proportion of those with either ED visit, pyelonephritis or sepsis within 30 days from study start |
| Positive urine cultures | 5 days | Proportion of participants with positive urine cultures |
| Change from Baseline in Recurrent Urinary Tract Infection Symptom Scale Score at 14 Days | 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. |
| Antibiotic appropriateness of Current Therapy | 5 days | Of those that received antibiotics, how many had a positive culture susceptible to the prescribed antibiotic |
Countries
United States
Contacts
CONTACTMegan S Bradley, MD MSc
PRINCIPAL_INVESTIGATORMegan Bradley, MD, MSc
University of Pittsburgh
Outcome results
None listed