A randomized controlled trial on the impact of bovhyaluronidase azoximer on ejaculate biofilms in patients with chronic prostatitis

Background: Bacterial biofilms play a key role in antibiotic resistance, infection recurrence, and reduced pathogen detection in prostatic secretion. Bovhyaluronidase azoximer is a biofilm-disrupting agent. This trial aimed to evaluate its effects on biofilms and clinical outcomes in patients with chronic prostatitis and associated infertility. Methods: Patients with chronic bacterial prostatitis and infertility completed the NIH-CPSI, IPSS, and QoL questionnaires, underwent microbiological culture of prostatic secretion, ejaculate, or the third portion of urine, light and electron microscopy of ejaculate before and after treatment. Patients were randomized into two groups treated with antibiotics combined with bovhyaluronidase azoximer, and antibiotics alone. Results: The experimental group showed greater improvements on the NIH-CPSI scale (MD −3.04, 95%CI: −3.77 to −2.3, p < 0.001). Significant reduction in bacterial colony count and neutrophil levels were detected in the experimental group. Ejaculate clearance from neutrophils and bacteria was more frequent in experimental group (41% vs 7.2%, p = 0.01; 41.7% vs 12.1%, p = 0.043). Electron microscopy revealed disappearance of the intercellular matrix of bacterial microcolonies only in the experimental group. Recurrence rates were significantly lower at both 6 months and 12 months in the experimental group. Conclusions: The combined use of bovhyaluronidase azoximer with antibiotics significantly improved symptoms, reduced leukocyte and bacterial counts, and lowered recurrence rates in patients with chronic prostatitis. Post-treatment microscopy confirmed the disruption of biofilm structures, suggesting enhanced microbial clearance.