Treatment of Asymptomatic Renal Calculi in Recurrent UTIs: a Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 6
- 主要终点
- Recurrent urinary tract infections
研究概览
简要总结
This study will assess patients who have recurrent urinary tract infections and kidney stones which are not blocking the kidney or causing other problems. Currently, we don't know if taking out these stones will improve recurrent urinary tract infections or not. Patients will make a decision with their surgeon about removing or monitoring their stone(s). Whether or not their infections continue with surgery or monitoring will be noted, and this information may help to inform future treatment decisions. The purpose of this study is to assess if treatment of these asymptomatic stones affects the rate of recurrent urinary tract infections.
详细描述
Urinary tract infections (UTIs) are common and have a large burden of disease at the population level. This study will assess the effectiveness of removing kidney stones in patients who have recurrent UTIs.
The role of upper urinary tract calculi in UTIs is not well understood. Although there is some evidence that some metabolic stones, such as calcium oxalate, can harbor bacteria, it is not known if this is clinically significant or if these contribute to clinical infections.
This study aims to advance the level of evidence in the treatment of non-obstructing urolithiasis in the context of recurrent UTIs.
The aim of this study is to:
1. Assess the effects of treatment of non-obstructing upper urinary tract calculi on recurrent UTIs in the first prospective observational trial in this area
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •age < 18 years
- •pregnancy
- •hydronephrosis or evidence of obstruction
- •presence of a foreign body in urinary tract (e.g. Foley, ureteral stent, nephrostomy tube) at the time of UTI diagnosis
- •concurrent bladder calculi
- •Urinary diversion or previous surgery involving segments of bowel interposed into the urinary tract (ileal conduit, ileal ureter etc.)
结局指标
主要结局
Recurrent urinary tract infections
时间窗: 12 months
• Number of UTIs, defined as positive urine culture (\>10\^5 CFU/mL of a specific organism) with symptoms. If having had surgical intervention for the stones, we will count a UTI during \>30days and \<1year after intervention so that it is not attributed to the intervention
次要结局
- Stone analysis correlation with rUTI(12 months)
- Correlation of selected demographic factors with rUTI(12 months)
- Number free from any UTI(12 months)
- Pyelonephritis/urosepsis(up to 12 months)
- Stone free vs not stone free correlation with rUTI(12 months)
- Crossover from observation to intervention(12 months)
- Time to first UTI(up to 12 months)
- Number free from recurrent UTIs(12 months)
- Incidence of complications from intervention within 30 days(30 days)
- Incidence of further intervention for stones(12 months)
研究者
Ryan Hsi
Associate Professor, Department of Urology
Vanderbilt University Medical Center