NCT04709601终止4 期
Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in the Management of Recurrent Urinary Tract Infections in Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Urinary Tract Infections
研究概览
简要总结
The purpose of this study is to measure the concentration of formaldehyde in the urine of women with recurrent urinary tract infections on Hiprex; and then, assuming its urinary presence is confirmed at the proper acid urinary pH, evaluate if such a therapy has favorable effects in decreasing the rate of recurrent urinary tract infections over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 50 - 85
- •Have RUTIs (at least 2 UTIs within the past 6 months or 3 within the past year) -
排除标准
- •Being on antibiotics at baseline (i.e. suppressive therapy or antibiotic therapy for urinary or non-urinary infections)
- •Neurogenic bladder condition
- •Using urinary catheters (including Foley catheter, intermittent catheterization, and suprapubic catheter)
- •Uncontrolled diabetes (HbA1c > 9)
- •Chronic renal failure defined as serum creatinine > 1.5 mg/dL
- •History of liver disease
- •Patients from out of town, in whom follow-up will not be possible
- •Allergy to Hiprex
- •Inability to take Hiprex reliably at home, such as having psychosis, dementia, or swallowing disorders
- •Non-English speakers -
研究组 & 干预措施
Group 1 - Patients with negative and positive urine culture
Experimental
干预措施: Hiprex (Drug)
结局指标
主要结局
Number of Urinary Tract Infections
时间窗: 1 year
It would be measured by counting the positive urine cultures, or UTI-like episodes requiring antibiotic treatment during the 1 year of the study period.
次要结局
- Severity of UTI Symptoms as Measured by the UTI Symptom Assessment Questionnaire(1 year)
- Duration of Intervals Between UTI Episodes(1 year)
- Frequency of Oral Antibiotic Use(1 year)
- Number of Participants That Used Oral Anti-biotic(1 year)
- Number of Hospital Re-admissions at 1 Year(1 year)
- Frequency and Severity of Adverse Events Related to Hiprex(1 year)
- Urine Acidity Levels(1 year)
- Number of Urinary Tract Infection Episodes(up to 1 year)
- Number of Urinary Tract Infection Episodes(up to 2 years)
研究者
Philippe Zimmern
Professor of Urology
University of Texas Southwestern Medical Center
研究点 (1)
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