Precision Management of Urinary Tract Symptoms in Older Women

NCT07686055 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: STUDY26050198
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection (Diagnosis)

Keywords

Urinary Tract Infection; Women; Older

Outcome Measures

Primary Outcomes (1)

• Clinical Success at 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.

  14 days

Secondary Outcomes (4)

• UTI sequelae

  30 days

• Positive urine cultures

  5 days

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

  14 days

• Antibiotic appropriateness of Current Therapy

  5 days

Study Arms (3)

Empiric (Immediate) Antibiotic Treatment

EXPERIMENTAL

Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current Infectious Disease Society of American (IDSA) guidelines. If there is a contraindication to the first antibiotic on the list they will progress to the next option until a suitable selection is achieved.

Drug: Antibiotics

Culture-directed Antibiotic Treatment

EXPERIMENTAL

Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h.

Drug: Antibiotics

Urinalysis-directed Antibiotic Treatment

EXPERIMENTAL

Participants will be directed to refrain from taking antibiotics until results of urinalysis reported, which is expected within 12-24 hours

Drug: Antibiotics

Interventions

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

Culture-directed Antibiotic Treatment; Empiric (Immediate) Antibiotic Treatment; Urinalysis-directed Antibiotic Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Megan Bradley: lead
• American Association of Obstetricians and Gynecologists Foundation (AAOGF): collaborator

Study Sites (1)

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Disease

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Megan Bradley, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan S Bradley, MD MSc

CONTACT

412-641-7850; bradleym4@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 14, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)