Transplant Trial Watch

A Randomized Clinical Trial Comparing Nitrofurazone-coated and Uncoated Urinary Catheters in Kidney Transplant Recipients: Results from a Pilot Study.

Menezes FG, CorrĂȘa L, et al.

Transpl Infect Dis. 2018; [record in progress].


Aims
To compare the efficacy of Nitrofurazone-coated silicone urinary catheters with non-impregnated silicone urinary catheters in reducing bacteriuria and urinary tract infections in kidney transplant recipients (KTR).

Interventions
Patients were randomized (1:1) to a Nitrofurazone-coated silicone urinary catheter or a non-impregnated silicone urinary catheter.

Participants
214 living donor KTRs were randomized and 176 completed the study.

Outcomes
The primary outcome was the incidence of asymptomatic bacteriuria and symptomatic urinary tract infection during the first 30 days after renal transplantation. Each patient was included only once as a case of urinary tract infection or asymptomatic bacteriuria. Urinalysis and urine cultures were scheduled for the transplant day (baseline), 7, 14 and 30 days after transplantation. Patients were questioned daily about discomfort with the device. After discharge, the evaluation schedule was: weekly for the first month, biweekly for the second month, and monthly at 3 months post-surgery.

Follow-up
>30 days post transplantation

CET Conclusions
This pilot, single-centre, open-label, randomised controlled trial (RCT) tested whether Nitrofurazone-coated silicone urinary catheters reduced asymptomatic bacteriuria and urinary tract infections in adult living donor kidney transplant recipients. A computer-generated sequence randomised patients to Nitrofurazone-coated silicone urinary catheters or non-impregnated silicone urinary catheters. There was no description of allocation concealment. A sample size calculation showed that 836 patients were needed to achieve 80% power for an absolute reduction of 7.7% in asymptomatic bacteriuria. Because of costs and the uncertainty of clinical benefits, it was decided to conduct a small pilot study to obtain preliminary results. 214 patients were randomised of whom 176 completed the study. There were no differences between groups in the reduction of bacteriuria and urinary tract infections. Patients reported higher levels of discomfort with the use of Nitrofurazone-coated catheter (46.6% versus 38.9%). The results of this preliminary analysis do not justify the design of a larger RCT comparing the efficacy of the two catheters.

Jadad score
3

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
ISRCTN - 57888785

Funding source
Non-industry funded