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Double Voiding and Post-transplant UTI

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Enrolling

Conditions

Urinary Tract Infections
Kidney Transplant; Complications

Treatments

Other: Regular Voiding
Other: Double Voiding

Study type

Interventional

Funder types

Other

Identifiers

NCT05711446
22-03024620

Details and patient eligibility

About

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.

Full 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.

Enrollment

438 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

438 participants in 2 patient groups

Double Voiding
Experimental group
Description:
The participant will be instructed to void twice.
Treatment:
Other: Double Voiding
Regular Voiding
Active Comparator group
Description:
The participant will be instructed to void normally.
Treatment:
Other: Regular Voiding

Trial contacts and locations

1

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Central trial contact

Muthukumar Thangamani, M.D.; Ananda Kimm-Drapeau

Data sourced from clinicaltrials.gov

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