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Double Voiding and Post-transplant UTI

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05711446
Enrollment
438
Registered
2023-02-03
Start date
2023-04-07
Completion date
2027-05-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant; Complications, Urinary Tract Infections

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.

Interventions

OTHERDouble Voiding

Participant will be instructed to void twice.

OTHERRegular Voiding

Participant will void as usual

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of UTI'sFirst 3 months of transplantationUTI 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

MeasureTime frameDescription
Time to first bacterial cultureFirst 3 months of transplantationTime will be measured in days
Number of UTI episodesFirst 3 months of transplantation
Bacterial colony count of each positive urine cultureFirst 3 months of transplantation
Number of incidences of bacteremiaFirst 3 months of transplantation
Number of hospital admissionsFirst 3 months of transplantation

Countries

United States

Contacts

CONTACTMuthukumar Thangamani, M.D.
mut9002@med.cornell.edu212-746-9074
CONTACTAnanda Kimm-Drapeau
alk4031@med.cornell.edu212-746-6137
PRINCIPAL_INVESTIGATORMuthukumar Thangamani, M.D.

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026