Double Voiding and Post-transplant UTI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Double Voiding, Regular Voiding.
- Who it may be relevant to
- Registry conditions: Urinary Tract Infections, Kidney Transplant; Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Trial of Double Voiding Versus Usual Voiding to Reduce the Incidence of Urinary Tract Infections in Kidney Transplant Recipients
Overview
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.
Interventions
- Other Double Voiding
Participant will be instructed to void twice. - Other Regular Voiding
Participant will void as usual
Primary outcome measures
- Number of UTI's [Time frame: First 3 months of transplantation]
Secondary outcome measures (5)
- Time to first bacterial culture [Time frame: First 3 months of transplantation]
- Number of UTI episodes [Time frame: First 3 months of transplantation]
- Bacterial colony count of each positive urine culture [Time frame: First 3 months of transplantation]
- Number of incidences of bacteremia [Time frame: First 3 months of transplantation]
- Number of hospital admissions [Time frame: First 3 months of transplantation]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Weill Cornell Medical College / NY Presbyterian — New York
Publications
- 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 23917724
- 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 33508852
- 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 27408706
- 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 1795193
Identifiers
NCT: NCT05711446 · 22-03024620