Precision management of urinary tract symptoms in older women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 randomized trial compares empiric antibiotics, urinalysis-guided therapy, and culture-directed care for urinary tract symptoms in women aged 65 and older with a history of recurrent UTIs. Participants are enrolled from UPMC and a research registry and followed for 28 days after randomization. The study combines patient-reported outcomes with laboratory data to determine which strategy benefits patients the most while supporting antibiotic stewardship. The goal is to identify precision care pathways that improve symptoms and quality of life in a high-risk population. Results could guide more targeted, effective management of recurrent UTIs in older women.

Why it matters

Who can join: the full rules

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)

Where it's running

• UPMC-Magee Womens Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Megan Bradley, MD, MSc — University of Pittsburgh
• Study coordinator: Megan S Bradley, MD MSc
• Email: bradleym4@upmc.edu
• Phone: 412-641-7850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.