Double Voiding and Post-transplant UTI

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05711446
Collaborator
(none)
438
1
2
34
12.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Double Voiding
  • Other: Regular Voiding
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
438 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Randomized Trial of Double Voiding Versus Usual Voiding to Reduce the Incidence of Urinary Tract Infections in Kidney Transplant Recipients
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Double Voiding

The participant will be instructed to void twice.

Other: Double Voiding
Participant will be instructed to void twice.

Active Comparator: Regular Voiding

The participant will be instructed to void normally.

Other: Regular Voiding
Participant will void as usual

Outcome Measures

Primary Outcome Measures

  1. Number of UTI's [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 Outcome Measures

  1. Time to first bacterial culture [First 3 months of transplantation]

    Time will be measured in days

  2. Number of UTI episodes [First 3 months of transplantation]

  3. Bacterial colony count of each positive urine culture [First 3 months of transplantation]

  4. Number of incidences of bacteremia [First 3 months of transplantation]

  5. Number of hospital admissions [First 3 months of transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weill Cornell Medical College / NY Presbyterian New York New York United States 10065

Sponsors and Collaborators

  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Muthukumar Thangamani, M.D., Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT05711446
Other Study ID Numbers:
  • 22-03024620
First Posted:
Feb 3, 2023
Last Update Posted:
Feb 3, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2023