Double Voiding and Post-transplant UTI

NCT ID: NCT05711446

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-07
• Study Completion Date: 2026-12-31

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.

Conditions

Urinary Tract Infections; Kidney Transplant; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Double Voiding

The participant will be instructed to void twice.

Group Type: EXPERIMENTAL

Double Voiding

Intervention Type: OTHER

Participant will be instructed to void twice.

Regular Voiding

The participant will be instructed to void normally.

Group Type: ACTIVE_COMPARATOR

Regular Voiding

Intervention Type: OTHER

Participant will void as usual

Interventions

Double Voiding

Participant will be instructed to void twice.

Intervention Type: OTHER

Regular Voiding

Participant will void as usual

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muthukumar Thangamani, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College / NY Presbyterian

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Muthukumar Thangamani, M.D.

Role: CONTACT

mut9002@med.cornell.edu

212-746-9074

Ananda Kimm-Drapeau

Role: CONTACT

alk4031@med.cornell.edu

212-746-6137

Facility Contacts

Thangamani Muthukumar, M.D.

Role: primary

mut9002@med.cornell.edu

212-746-9074

Ananda Kimm-Drapeau

Role: backup

alk4031@med.cornell.edu

212-746-6137

References

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.

Reference Type: BACKGROUND

PMID: 23917724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33508852 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27408706 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1795193 (View on PubMed)

Other Identifiers

22-03024620

Identifier Type: -

Identifier Source: org_study_id