The Efficacy of Flogofilm® in the Treatment of Chronic Bacterial Prostatitis as an Adjuvant to Antibiotic Therapy: A Randomized Prospective Trial

Abstract

Introduction: Bacterial prostatitis (BP) is a common prostatic infection characterized by a bimodal distribution in young and older men, with a prevalence between 5–10% among all cases of prostatitis and a high impact on quality of life. Although the management of bacterial prostatitis involves the use of appropriate spectrum antibiotics, which represent the first choice of treatment, a multimodal approach encompassing antibiotics and nutraceutical products in order to improve the efficacy of chosen antimicrobial regimen is often required. Objective: To evaluate the efficacy of Flogofilm® in association with fluoroquinolones in patients with chronic bacterial prostatitis (CBP). Methods: Patients diagnosed with prostatitis (positivity to Meares–Stamey Test and symptoms duration > 3 months) at the University of Naples “Federico II”, Italy, from July 2021 to December 2021, were included in this study. All patients underwent bacterial cultures and trans-rectal ultrasounds. Patients were randomized into two groups (A and B) receiving antibiotic alone or an association of antibiotics plus Flogofilm® tablets containing Flogomicina® for one month, respectively. The NIH-CPSI and IPSS questionnaires were administered at baseline, four weeks, twelve and twenty-four weeks. Results: A total of 96 (Group A = 47, Group B = 49) patients concluded the study protocol. The mean age was comparable, with a mean age of 34.62 ± 9.04 years for Group A and 35.29 ± 10.32 years for Group B (p = 0.755), and IPSS at the baseline was 8.28 ± 6.33 and 9.88 ± 6.89 (p = 0.256), respectively, while NIH-CPSI at baseline was 21.70 ± 4.38 and 21.67 ± 6.06 (p = 0.959), respectively. At 1, 3 and 6 months, the IPSS score was 6.45 ± 4.8 versus 4.31 ± 4.35 (p = 0.020), 5.32 ± 4.63 versus 3.20 ± 3.05 (p = 0.042) and 4.91 ± 4.47 versus 2.63 ± 3.28 (p = 0.005) for Groups A and B, respectively. Similarly, the NIH-CPSI total score at 1, 3 and 6 months was 16.15 ± 3.31 versus 13.10 ± 5.03 (p < 0.0001), 13.47 ± 3.07 versus 9.65 ± 4.23 (p < 0.0001) and 9.83 ± 2.53 versus 5.51 ± 2.84 (p < 0.0001), respectively. Conclusions: Flogofilm®, associated with fluoroquinolones, demonstrate a significant improvement in pain, urinary symptoms and quality of life in patients affected by chronic bacterial prostatitis in both IPSS and NIH-CPSI scores compared with fluoroquinolones alone.

Novel Key Ingredients in Urinary Tract Health—The Role of D-mannose, Chondroitin Sulphate, Hyaluronic Acid, and N-acetylcysteine in Urinary Tract Infections (Uroial PLUS®)

“…Additionally, it seems that NAC penetrates the biofilm matrix and it is able to kill the bacteria within, via the dissociation and acidification of bacterial cytoplasm, leaving an empty gel-like matrix [ 55 ]. A concentration of 2 g per liter of NAC is able to inhibit E. coli biofilm formation by 20–40%, rising to 90% at a concentration of 4 g per liter [ 56 , 57 ]. The disruption of the bacterial biofilm, which represents a protective mechanism used by bacteria to resist the host immune response and antibiotic treatment, enhances the susceptibility of bacteria to conventional antibiotics, making them more effective in eradicating the infection [ 58 , 59 ].…”

Efficacy Analysis of Physical Therapy in Treating Chronic Prostatitis: Unblocking Obstructed Glandular Ducts Could Be a Novel Treatment Strategy

“…Medication alone was often ineffective in treating refractory prostatitis. 24 Multidisciplinary treatment of CP is necessary. 25,26 When the glandular ducts of the prostate are unblocked, drugs can more easily penetrate into the gland.…”

Characterizing CD8+ TEMRA Cells in CP/CPPS Patients: Insights from Targeted Single-Cell Transcriptomic and Functional Investigations

“…In terms of treatment, antibiotics are the first-line therapy for the former, and combination with nutraceutical products, such as Flogofilm @ , significantly improves therapeutic efficacy. 4 However, the latter, also known as chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), is characterized by a combination of pain and urinary and sexual symptoms and has a poorly understood pathogenesis, 5,6 often leading to inadequate treatment outcomes. Recent progress in the fields of immunology and molecular biology has opened new avenues for understanding the underlying mechanisms of this condition.…”