A Randomized Trial of Double Voiding Versus Usual Voiding to Reduce the Incidence of Urinary Tract Infections in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Number of UTI's
研究概览
简要总结
Urinary tract infections (UTI) are common in kidney transplant recipients and are an important cause of illness and hospital admissions. Past studies have shown that about 1 out of 5 of newly transplanted patients develop UTI within their first 3 months of transplantation. Such UTIs increase the risk for blood stream infection and acute rejection of the kidney, Improvements in urinary voiding techniques may reduce the frequency of UTI. The purpose of this study is to evaluate the benefits of "double voiding" in kidney transplant recipients.
详细描述
Urinary tract infections are common in kidney transplant recipients and are an important cause of morbidity and hospital readmissions. Several risk factors for UTI, both modifiable and unmodifiable, have been described in the literature. In normal (non-transplant) individuals, because of the anatomy of the ureter insertion into the bladder that creates a valve-like effect during voiding, reflux of urine into the kidney is prevented . However, after kidney transplantation, urine refluxing into the transplanted kidney is common. Depending on the surgical technique used for connecting the transplant ureter to the urinary bladder, reflux may occur in up to 79% of kidney transplant recipients. In addition, the routine usage of ureteral stents (double J stents) for the first 4-6 weeks after transplantation results in reflux. Vesicoureteral reflux increases the risk of UTI Double voiding, a process of passing urine more than once each time, is a technique that may assist the bladder to empty more effectively when urine is left in the bladder. By reducing the amount of left-over urine in the bladder after each void, double voiding may help reduce the incidence of UTI in kidney transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •All adult kidney transplant recipients who undergo routine follow-up at the New York Presbyterian - Weill Cornell Medicine (NYP-WCM) Transplant Clinic.
排除标准
- •Kidney transplant recipients who are discharged after a transplant with an indwelling catheter (Foley)
研究组 & 干预措施
Double Voiding
The participant will be instructed to void twice.
干预措施: Double Voiding (Other)
Regular Voiding
The participant will be instructed to void normally.
干预措施: Regular Voiding (Other)
结局指标
主要结局
Number of UTI's
时间窗: First 3 months of transplantation
UTI will be defined as a clean catch urine bacterial culture that is reported as anything other than "\<1000 CFU/ml (Colony Forming Unit / Milliliter)- Negative". Clean catch urine cultures are done at each follow-up visit as a standard of care, irrespective of patient symptoms. Hence the outcome will include both asymptomatic and symptomatic UTIs.
次要结局
- Number of hospital admissions(First 3 months of transplantation)
- Number of UTI episodes(First 3 months of transplantation)
- Bacterial colony count of each positive urine culture(First 3 months of transplantation)
- Time to first bacterial culture(First 3 months of transplantation)
- Number of incidences of bacteremia(First 3 months of transplantation)