Double Voiding and Post-transplant UTI

Not Applicable

Recruiting

• Conditions: Kidney Transplant; Complications; Urinary Tract Infections
• Interventions: Other: Regular Voiding; Other: Double Voiding

• Registration Number: NCT05711446
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-03
• Study Start: 2023-04-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 438

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular Voiding	Regular Voiding	The participant will be instructed to void normally.
Double Voiding	Double Voiding	The participant will be instructed to void twice.

Primary Outcome Measures

Name	Time	Method
Number of UTI's	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.

Secondary Outcome Measures

Name	Time	Method
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	Time will be measured in days
Number of incidences of bacteremia	First 3 months of transplantation

Trial Locations

Locations (1)

Weill Cornell Medical College / NY Presbyterian; 🇺🇸 New York, New York, United States