NCT05711446

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Apr 2023Dec 2026

First Submitted

Initial submission to the registry

December 20, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

December 20, 2022

Last Update Submit

June 16, 2025

Conditions

Urinary Tract InfectionsKidney Transplant; Complications

Outcome Measures

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.

    First 3 months of transplantation

Secondary Outcomes (5)

  • Time to first bacterial culture

    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

  • Number of incidences of bacteremia

    First 3 months of transplantation

  • Number of hospital admissions

    First 3 months of transplantation

Study Arms (2)

Double Voiding

EXPERIMENTAL

The participant will be instructed to void twice.

Other: Double Voiding

Regular Voiding

ACTIVE COMPARATOR

The participant will be instructed to void normally.

Other: Regular Voiding

Interventions

Double VoidingOTHER

Participant will be instructed to void twice.

Double Voiding
Regular VoidingOTHER

Participant will void as usual

Regular Voiding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College / NY Presbyterian

New York, New York, 10065, United States

RECRUITING

Related Publications (4)

  • Lee JR, Bang H, Dadhania D, Hartono C, Aull MJ, Satlin M, August P, Suthanthiran M, Muthukumar T. Independent risk factors for urinary tract infection and for subsequent bacteremia or acute cellular rejection: a single-center report of 1166 kidney allograft recipients. Transplantation. 2013 Oct 27;96(8):732-8. doi: 10.1097/TP.0b013e3182a04997.

    PMID: 23917724BACKGROUND

  • Sarier M, Yayar O, Yavuz A, Turgut H, Kukul E. Update on the Management of Urological Problems Following Kidney Transplantation. Urol Int. 2021;105(7-8):541-547. doi: 10.1159/000512885. Epub 2021 Jan 28.

    PMID: 33508852BACKGROUND

  • Garcia-Roig ML, Kirsch AJ. Urinary tract infection in the setting of vesicoureteral reflux. F1000Res. 2016 Jun 30;5:F1000 Faculty Rev-1552. doi: 10.12688/f1000research.8390.1. eCollection 2016.

    PMID: 27408706BACKGROUND

  • Staessen J, Celis H, De Cort P, Fagard R, Thijs L, Amery A. Methods for describing the diurnal blood pressure curve. J Hypertens Suppl. 1991 Dec;9(8):S16-8.

    PMID: 1795193BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Muthukumar Thangamani, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muthukumar Thangamani, M.D.

CONTACT

212-746-9074mut9002@med.cornell.edu

Ananda Kimm-Drapeau

CONTACT

212-746-6137alk4031@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2022

First Posted

February 3, 2023

Study Start

April 7, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)