Double Voiding and Post-transplant UTI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All adult kidney transplant recipients who undergo routine follow-up at the New York Presbyterian - Weill Cornell Medicine (NYP-WCM) Transplant Clinic.

Disqualifiers

Kidney transplant recipients who are discharged after a transplant with an indwelling catheter (Foley)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Double Voiding

    Other intervention

    Participant will be instructed to void twice.

  • Regular Voiding

    Other intervention

    Participant will void as usual

Treatment groups

438 Participants
are divided into 2 treatment groups
Group A: Double VoidingExperimental treatment 1 intervention
Group B: Regular VoidingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
First 3 months of transplantation

Secondary outcomes

1

Time to first bacterial culture

Time will be measured in days

Time frame
First 3 months of transplantation
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

Other outcomes

Sponsors and contacts

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