Precision Management of Urinary Tract Symptoms in Older Women

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Antibiotics
  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

Первичные конечные точки

• Clinical Success at 14 Days [Срок оценки: 14 days]

Вторичные конечные точки (4)

• UTI sequelae [Срок оценки: 30 days]
• Positive urine cultures [Срок оценки: 5 days]
• Change from Baseline in Recurrent Urinary Tract Infection Symptom Scale Score at 14 Days [Срок оценки: 14 days]
• Antibiotic appropriateness of Current Therapy [Срок оценки: 5 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UPMC-Magee Womens Hospital — Pittsburgh

Идентификаторы

NCT: NCT07686055 · STUDY26050198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗