Efficiacy of Prostatex Plus in the prevention of prostate biopsy complications

   Introduction. The most frequent complications after fine-needle biopsy of the prostate gland are infections and inflammations, which can occur in up to 17 % of cases. Currently, there is no standardised protocol for preventing infectious complications, including the choice of medication, duration, and timing of administration.

   Objective. To evaluate the effectiveness of Prostatex Plus in combination therapy after prostate biopsy compared with the generally accepted approach to patient management.

   Materials and methods. A prospective study involved 62 men undergoing examination and treatment at the Regional Clinical and Diagnostic Centre «Zdorovie». Transrectal biopsy was performed using a Philips HD 11 ultrasound scanner with an endfire transrectal probe. All patients were divided into two groups: Group 1 — 30 people who received antibacterial therapy plus Prostatex Plus for 20 days. Patients completed standard urological questionnaires IPSS and NIH-CPSI preoperatively, on day 7 and 30.

   Results. Group 1 patients showed worsening of symptoms at 7 and 30 days after biopsy compared to preoperative values according to IPSS. Aggravation of symptoms severity according to the NIH-CPSI questionnaire was observed on the day 7, by the day 30 the worsening of symptoms levelled out. Similar results were obtained when analysing the indicators of group 2: both IPSS and NIH-CPSI questionnaire showed worsening of the patients' condition by the post-op day 7, and on the post-op day 30 it was statistically significantly higher in comparison with the primary indicators (p = 0,001). Patients with a history of abacterial prostatitis showed a difference in IPSS scores 30 days after biopsy (p = 0.020). A similar situation was observed regarding pain syndrome according to the NIH-CPSI.

   Conclusion. Patients with abacterial prostatitis who received Prostatex Plus showed statistically significant improvement in the symptomatology of urinary disorders and pain syndrome than patients who received antimicrobial therapy alone.

1. Cornford P, van den Bergh RCN, Briers E, Van den Broeck T, Brunckhorst O, Darraugh J, Eberli D, De Meerleer G, De Santis M, Farolfi A, Gandaglia G, Gillessen S, Grivas N, Henry AM, Lardas M, van Leenders GJLH, Liew M, Linares Espinos E, Oldenburg J, van Oort IM, Oprea-Lager DE, Ploussard G, Roberts MJ, Rouvière O, Schoots IG, Schouten N, Smith EJ, Stranne J, Wiegel T, Willemse PM, Tilki D. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer-2024 Update. Part I: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2024;86(2):148-163. DOI: 10.1016/j.eururo.2024.03.027

2. Kaprin A.D., Alekseev B.I., Matveev V.B., Pushkar’ D.I., Govorov A.V., Gorban’ N.A., Kirichek A.A., Biriukov V.A., Volkova M.I., Gulidov I.A., Gumenetskaia I.V., Krylov V.V., Kariakin O.B., Krasheninnikov A.A., Mardynskii I.S., Niushko K.M., Zakharova T.I., Kostin A.A., Khmelevskii E.V., Fedenko A.A., Bolotina L.V., Falaleeva N.A., Filonenko E.V., Nevol’skikh A.A., Ivanov S.A., Khailova Z.V., Gevorkian T.G. Prostate cancer. Journal of Modern Oncology. 2021;23(2):211-247. (In Russian). DOI: 10.26442/18151434.2021.2.200959

3. Wenzel M, Theissen L, Preisser F, Lauer B, Wittler C, Humke C, Bodelle B, Ilievski V, Kempf VAJ, Kluth LA, Chun FKH, Mandel P, Becker A. Complication Rates After TRUS Guided Transrectal Systematic and MRI-Targeted Prostate Biopsies in a High-Risk Region for Antibiotic Resistances. Front Surg. 2020;7:7. DOI: 10.3389/fsurg.2020.00007

4. Keln A.A., Zyryanov A.V., Izmailov A.A., Zotov P.B., Znobishchev V.G., Ponomarev А.V. Comparative analysis of adverse events using different methods of prostate biopsy. Cancer Urology. 2019;15(1):66-74. (In Russian). DOI: 10.17650/1726-9776-2019-15-1-66-74

5. Palagin I.S., Suhorukova M.V., Dehnich A.V., Eydelshteyn M.V., Perepanova T.S., Kozlov R.S., issledovatelskaya gruppa «DARMIS-2018». Anti-microbial resistance of pathogens causing communityacquired urinary tract infections in russia: results of multicenter study «DARMIS-2018». Klinicheskaya mikrobiologiya i antimikrobnaya himioterapiya = Clinical Microbiology and Antimicrobial Chemotherapy. 2019;21(2):134-146. (In Russian). DOI: 10.36488/cmac.2019.2.134-146

6. Borghesi M, Ahmed H, Nam R, Schaeffer E, Schiavina R, Taneja S, Weidner W, Loeb S. Complications After Systematic, Random, and Image-guided Prostate Biopsy. Eur Urol. 2017;71(3):353-365. DOI: 10.1016/j.eururo.2016.08.004

7. Popov S.V., Orlov I.N., Chernysheva D.Yu., Topuzov T.M., Malevich S.M., Neradovsky V.A. Options for antibacterial prophylaxis of infectious complications of prostate biopsy. Review of international guidelines. Experimental and Clinical Urology. 2021;14(3):150-155. (In Russian). DOI: 10.29188/2222-8543-2021-14-3-150-155

8. Nashivochnikova N.A. Comparative evaluation of the effectiveness of drugs with prostate extract in the complex therapy of patients with chronic prostatitis. Experimental and Clinical Urology. 2023;16(3):119-128. (In Russian). DOI: 10.29188/2222-8543-2023-16-3-119-128

9. Neymark A.I., Nozdrachev N.A., Kulchavenya E.V., Kholtobin D.P., Davydov A.V., Neymark A.B., Kovaleva Yu.S., Yakovlev A.V. Use of the drug Prostatex plus in patients with chronic abacterial prostatitis and BPH. Urologiia. 2024;(2):41-46. (In Russian). DOI: 10.18565/urology.2024.2.41-46

10. Loeb S, van den Heuvel S, Zhu X, Bangma CH, Schröder FH, Roobol MJ. Infectious complications and hospital admissions after prostate biopsy in a European randomized trial. Eur Urol. 2012;61(6):1110-1114. DOI: 10.1016/j.eururo.2011.12.058

11. Nesterov S.N., Hanaliev B.V., Bonetsky B.A., Volodichev V.V., Vasilyev V.R., Magomedov Sh.S. Infectious-inflammatory lesions in patients with concomitant chronic prostatitis after surgical interventions on the prostate in the early postoperative period. Bulletin of the Pirogov National Medical and Surgical Center. 2018;13(1):85-87. (In Russian).

12. Grigoryev N.A., Abdullin I.I., Gvasalia B.R., Loginov A.V., Zhilyaev E.V. Combined antibiotic prophylaxis of infectious complications of prostate biopsy. Andrology and Genital Surgery. 2021;22(3):49-55. (In Russian). DOI: 10.17650/1726-9784-2021-22-3-49-55

13. Kadyrov Z.A., Faniev M.V., Sosnovskiy I.B., Shevchenko N.P. Prevention of infectious complications after transrectal multifocal prostate biopsy: evaluation of the effectiveness of the combined antimicrobial drug Combiflox®. Experimental and Clinical Urology. 2019;(1):140-145. (In Russian). DOI: 10.29188/2222-8543-2019-11-1-140-144

14. Spivak L.G., Platonova D.V. Efficacy and safety of using the drug Vitaprost® Plus in patients with chronic bacterial prostatitis, as well as in patients with benign prostatic hyperplasia before and after transurethral resection for the prevention of complications. Effektivnaya farmakoterapiya = Effective pharmacotherapy. 2017;24:16-21. (In Russian).

15. Pavlov V.N., Kazikhinurov A.A., Kazikhinurov R.A., Sabirzyanov S.S., Saleeva Y.D., Kazikhinurova K.A. The use of prostate extract preparations in patients after transurethral resection of prostate for its benign hyperplasia. Urologiia. 2022;(6):42-46. (In Russian). DOI: 10.18565/urology.2022.6.42-46