Precision Management of Urinary Tract Symptoms in Older Women: A Randomized Trial to Reduce Overtreatment
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical Success at 14 Days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Clinical Success at 14 Days
时间窗: 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.
次要结局
- 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)
研究者
Megan Bradley
Associate Professor
University of Pittsburgh