Health TrialsbyHealthPanel

Precision Management of Urinary Tract Symptoms in Older Women

ConditionUrinary Tract Infection (Diagnosis)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age65+
SponsorMegan Bradley

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Dysuria, increased urinary urgency/frequency and/or suprapubic pain

Disqualifiers

Male biologic sex

Age <65 years old

History of augmentation cystoplasty or cystectomy

Currently performing clean intermittent self-catheterization

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Empiric (Immediate) Antibiotic TreatmentExperimental treatment 1 intervention
Group B: Culture-directed Antibiotic TreatmentExperimental treatment 1 intervention
Group C: Urinalysis-directed Antibiotic TreatmentExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
14 days

Secondary outcomes

1

UTI sequelae

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

Time frame
30 days
2

Positive urine cultures

Proportion of participants with positive urine cultures

Time frame
5 days
3

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

Time frame
14 days
4

Antibiotic appropriateness of Current Therapy

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

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Megan Bradley

Lead sponsor

University of Pittsburgh

Sponsor institution

American Association of Obstetricians and Gynecologists Foundation (AAOGF)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: