Double Voiding and Post-transplant UTI

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711446
• Other study ID #: 22-03024620
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2023
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Weill Medical College of Cornell University
• Contact: Muthukumar Thangamani, M.D.
• Phone: 212-746-9074
• Email: mut9002[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 438
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Infections
• Kidney Transplant; Complications
• Urinary Tract Infections

Intervention

Other:
• Double Voiding
Participant will be instructed to void twice.
• Regular Voiding
Participant will void as usual

Locations

Country	Name	City	State
United States	Weill Cornell Medical College / NY Presbyterian	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to first bacterial culture	Time will be measured in days	First 3 months of transplantation
Secondary	Number of UTI episodes		First 3 months of transplantation
Secondary	Bacterial colony count of each positive urine culture		First 3 months of transplantation
Secondary	Number of incidences of bacteremia		First 3 months of transplantation
Secondary	Number of hospital admissions		First 3 months of transplantation