Double Voiding and Post-transplant UTI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Trial of Double Voiding Versus Usual Voiding to Reduce the Incidence of Urinary Tract Infections in Kidney Transplant Recipients

Conditions
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Urinary Tract Infections, Kidney Transplant; Complications

Intervention / Treatment
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* Other: Double Voiding
* Other: Regular Voiding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult kidney transplant recipients who undergo routine follow-up at the New York Presbyterian - Weill Cornell Medicine (NYP-WCM) Transplant Clinic. Exclusion Criteria: Kidney transplant recipients who are discharged after a transplant with an indwelling catheter (Foley)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double Voiding<br>The participant will be instructed to void twice. | Other: Double Voiding<br>* Participant will be instructed to void twice.<br>|
| Active Comparator: Regular Voiding<br>The participant will be instructed to void normally. | Other: Regular Voiding<br>* Participant will void as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of UTI's | 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. | First 3 months of transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first bacterial culture | Time will be measured in days | 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 | 
| Number of incidences of bacteremia |  | First 3 months of transplantation | 
| Number of hospital admissions |  | First 3 months of transplantation |