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Double Voiding and Post-transplant UTI

Primary Purpose

Urinary Tract Infections, Kidney Transplant; Complications

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Double Voiding
Regular Voiding
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Weill Cornell Medical College / NY PresbyterianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Double Voiding

Regular Voiding

Arm Description

The participant will be instructed to void twice.

The participant will be instructed to void normally.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to first bacterial culture
Time will be measured in days
Number of UTI episodes
Bacterial colony count of each positive urine culture
Number of incidences of bacteremia
Number of hospital admissions

Full Information

First Posted
December 20, 2022
Last Updated
August 29, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT05711446
Brief Title
Double Voiding and Post-transplant UTI
Official Title
A Randomized Trial of Double Voiding Versus Usual Voiding to Reduce the Incidence of Urinary Tract Infections in Kidney Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Kidney Transplant; Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double Voiding
Arm Type
Experimental
Arm Description
The participant will be instructed to void twice.
Arm Title
Regular Voiding
Arm Type
Active Comparator
Arm Description
The participant will be instructed to void normally.
Intervention Type
Other
Intervention Name(s)
Double Voiding
Intervention Description
Participant will be instructed to void twice.
Intervention Type
Other
Intervention Name(s)
Regular Voiding
Intervention Description
Participant will void as usual
Primary Outcome Measure Information:
Title
Number of UTI's
Description
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 Outcome Measure Information:
Title
Time to first bacterial culture
Description
Time will be measured in days
Time Frame
First 3 months of transplantation
Title
Number of UTI episodes
Time Frame
First 3 months of transplantation
Title
Bacterial colony count of each positive urine culture
Time Frame
First 3 months of transplantation
Title
Number of incidences of bacteremia
Time Frame
First 3 months of transplantation
Title
Number of hospital admissions
Time Frame
First 3 months of transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muthukumar Thangamani, M.D.
Phone
212-746-9074
Email
mut9002@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ananda Kimm-Drapeau
Phone
212-746-6137
Email
alk4031@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muthukumar Thangamani, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College / NY Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thangamani Muthukumar, M.D.
Phone
212-746-9074
Email
mut9002@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Ananda Kimm-Drapeau
Phone
212-746-6137
Email
alk4031@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Thangamani Muthukumar, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23917724
Citation
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.
Results Reference
background
PubMed Identifier
33508852
Citation
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.
Results Reference
background
PubMed Identifier
27408706
Citation
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.
Results Reference
background
PubMed Identifier
1795193
Citation
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.
Results Reference
background

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Double Voiding and Post-transplant UTI

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