Antibacterial prophylaxis with fosfomycin at the time of the urethral catheter removal after radical prostatectomy (prospective randomized trial)

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Abstract

Aim. To evaluate the effect of antibacterial prophylaxis using oral fosfomycin during the removal of a urethral catheter after radical prostatectomy on the development of urinary tract infection, severity of leukocyturia and bacteriuria, as well as the severity of lower urinary tract symptoms.

Materials and methods. A single-center, non-blind, prospective, randomized controlled trial was carried out. The main group included 40 patients, and the control group included 37 patients. In the group 1, patients received two doses of oral fosfomycin, 3 g, namely in the evening on the day of catheter removal (the first dose) and 48 hours after catheter removal (the second dose). In the group 2, patients did not receive any antibacterial prophylaxis after urethral catheter removal. The endpoints of the study were confirmed episodes of urinary tract infection within 1 month after removal of the urethral catheter, leukocyturia and bacteriuria in urinalysis/urine culture) and severity of the lower urinary tract symptoms assessed by IPSS questionnaire.

Results. In the group 2, urinary tract infection was noted in 17.1%, while in the group 2 only in 2.6% of patients (p=0.032). Leukocyturia and bacteriuria were significantly less common in the group receiving antibacterial prophylaxis with fosfomycin (18.4% vs. 48.6%, respectively; p=0.006). Positive urine culture was observed in 7.9% vs. 25.7%, respectively (p=0.035). Four weeks after removal of the urethral catheter, the average IPSS score was significantly higher in the group 2 (13.2 vs. 9.5 points; p=0.002). There were no cases of allergic reaction and pseudomembranous colitis associated with C. difficile in both groups. Diarrhea cured with sorbents was noted in 2 patients (5.2%) in fosfomycin group.

Conclusion. Antibacterial prophylaxis using two oral doses of fosfomycin 3 g on the day of urethral catheter removal and 48 hours after catheter removal after radical prostatectomy appears to be an effective scheme that reduces the incidence of urinary tract infection and the severity of lower urinary tract symptoms, and is characterized by a minimal risk of adverse events. It is necessary to carried out further research and develop clear recommendations for antibacterial prevention in urological interventions requiring prolonged urethral catheterization.

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About the authors

E. I. Veliev

Russian Medical Academy of Continuous Professional Education (RMACPE), Department of Urology and Surgical Andrology; S.P. Botkin’s State Clinical Hospital

Email: veliev64@gmail.com

Ph.D., MD, professor, professor at the Department of Urology and Surgical Andrology of Russian Medical Academy of Continuous Professional Education (RMACPE), Head of the Department of Urology of S.P. Botkin’s State Clinical Hospital

Russian Federation, Moscow; Moscow

E. A. Sokolov

Russian Medical Academy of Continuous Professional Education (RMACPE), Department of Urology and Surgical Andrology; S.P. Botkin’s State Clinical Hospital

Author for correspondence.
Email: info@drsokolov.ru

Ph.D., MD, associate professor of the Department of Urology and Surgical Andrology of Russian Medical Academy of Continuous Professional Education (RMACPE), urologist at the S.P. Botkin’s State Clinical Hospital

Russian Federation, Moscow; Moscow

A. Yu. Metelev

S.P. Botkin’s State Clinical Hospital

Email: urometelev@mail.ru

Ph.D., oncologist, urologist at the S.P. Botkin’s State Clinical Hospital

Russian Federation, Moscow

E. N. Aliev

S.P. Botkin’s State Clinical Hospital

Email: esedulaaliev@mail.ru

resident at the S.P. Botkin’s State Clinical Hospital

Russian Federation, Moscow

A. S. Polyakova

Russian Medical Academy of Continuous Professional Education (RMACPE), Department of Urology and Surgical Andrology

Email: plkvs46@mail.ru

Ph.D. student at the Department of Urology and Surgical Andrology of Russian Medical Academy of Continuous Professional Education (RMACPE)

Russian Federation, Moscow

E. V. Ivkin

S.P. Botkin’s State Clinical Hospital

Email: e.ivkin@hotmail.com

Ph.D., oncologist, urologist at the S.P. Botkin’s State Clinical Hospital

Russian Federation, Moscow

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Supplementary files

Supplementary Files
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1. JATS XML
2. Fig. 1. Flowchart characterizing the patient recruitment and follow-up process

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3. Fig. 2. Severity of SNMP according to the IPSS questionnaire 4 weeks after urethral catheter removal

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