Precision Management of Urinary Tract Symptoms in Older Women

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.

• Antibiotics (Drug): 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

Primary outcomes

• 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 outcomes

• 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

Sex: Female, ages: 65 Years to any

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)

• Megan Bradley, MD, MSc, Principal investigator, University of Pittsburgh