NCT06684626

The Role of Butirprost® in Combination With Antibiotics in Chronic Bacterial Prostatitis (CBP) Treatment

The Role of Butirprost® as an Adjuvant in Enhancing the Effect of Antibiotics in Patients Affected by Chronic Bacterial Prostatitis: A Randomized Prospective Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Bacterial prostatitis (BP) is a common prostatic infection characterized by pain and urinary symptoms, often with negative bacterial cultures from prostatic secretions. It affects young and older men bimodally and significantly impacts quality of life (QoL). Treatment typically involves antibiotics, but a multimodal approach with additional nutraceuticals may enhance outcomes. This work aims to assess the efficacy of Butirprost® in association with fluoroquinolones in patients with Chronic Bacterial Prostatitis (CBP).

Conditions

• Prostate Inflammation
• Prostate Disease
• Chronic Bacterial Prostatitis

Interventions

Type	Name	Description
DRUG	Sodium Hyaluronate	Sodium Hyaluronate (Butirprost®) is a nutraceutical formulation in suppository form, designed for the management of chronic bacterial prostatitis (CBP). It contains key ingredients such as sodium hyaluronate, a derivative of hyaluronic acid (HA), along with Plantago major. Sodium hyaluronate is valued for its potent anti-inflammatory and tissue-regenerative properties, while Plantago major offers additional benefits through its soothing and wound-healing effects, enhancing the overall efficacy of the formulation in treating CBP.
DRUG	Levofloxacin 500mg	Treatment typically involves fluoroquinolones alone, such as levofloxacin.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-07-31
• Completion: 2024-09-01
• First posted: 2024-11-12
• Last updated: 2024-11-18

Locations

1 site across 1 country: Italy