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NCT Number: NCT07686055

Precision Management of Urinary Tract Symptoms in Older Women

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.

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Key information

Conditions

Urinary Tract Infection (Diagnosis) Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location contact

Megan Bradley, MD, MSc

PRINCIPAL_INVESTIGATOR

Megan S Bradley, MD, MSc

CONTACT

[email protected]

412-641-7850

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

  1. Clinical Success at 14 Days

    Time frame: 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

  1. UTI sequelae

    Time frame: 30 days

    Proportion of those with either ED visit, pyelonephritis or sepsis within 30 days from study start

  2. Positive urine cultures

    Time frame: 5 days

    Proportion of participants with positive urine cultures

  3. Change from Baseline in Recurrent Urinary Tract Infection Symptom Scale Score at 14 Days

    Time frame: 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.

  4. Antibiotic appropriateness of Current Therapy

    Time frame: 5 days

    Of those that received antibiotics, how many had a positive culture susceptible to the prescribed antibiotic

Study contacts

Contact information is provided by the study sponsor or research team.

Megan S Bradley, MD MSc

CONTACT

[email protected]

412-641-7850

Sponsors and collaborators

Lead sponsor

Megan Bradley

Other

Collaborators

  • American Association of Obstetricians and Gynecologists Foundation (AAOGF)

Registry information

Official study title

Precision Management of Urinary Tract Symptoms in Older Women: A Randomized Trial to Reduce Overtreatment

Acronym: GUIDE-UTI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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