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NCT Number: NCT05711446

Double Voiding and Post-transplant UTI

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College / NY Presbyterian

New York, 10065, United States

Location status: Recruiting

Location contact

Ananda Kimm-Drapeau

CONTACT

[email protected]

212-746-6137

Thangamani Muthukumar, M.D.

CONTACT

[email protected]

212-746-9074

Thangamani Muthukumar, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Double Voiding

Other

Participant will be instructed to void twice.

Regular Voiding

Other

Participant will void as usual

Primary outcomes

  1. Number of UTI's

    Time frame: 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 outcomes

  1. Time to first bacterial culture

    Time frame: First 3 months of transplantation

    Time will be measured in days

  2. Number of UTI episodes

    Time frame: First 3 months of transplantation

  3. Bacterial colony count of each positive urine culture

    Time frame: First 3 months of transplantation

  4. Number of incidences of bacteremia

    Time frame: First 3 months of transplantation

  5. Number of hospital admissions

    Time frame: First 3 months of transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Ananda Kimm-Drapeau

CONTACT

[email protected]

212-746-6137

Muthukumar Thangamani, M.D.

CONTACT

[email protected]

212-746-9074

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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