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

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).

Study Overview

• Status: Completed
• Conditions: Prostate Disease; Chronic Bacterial Prostatitis; Prostate Inflammation
• Intervention / Treatment: Drug: Sodium Hyaluronate; Drug: Levofloxacin 500mg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80131
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patient aged between 18 and 50 years
• symptoms consistent with CBP
• positive Mears-Stamey test

Exclusion Criteria:

• patients younger than 18 years
• history of neurological disease, urinary stones or cancer
• allergy to fluoroquinolones or any components of Butirprost®
• post-void residual > 50 mL
• Use of alpha-blockers or 5-alpha-reductase inhibitors (5-ARI)
• previous prostatic surgery, antibiotic treatment within four weeks prior to the study
• refusal to provide informed consent and incomplete follow-up data
• Patients testing positive for certain pathogens like Chlamydia trachomatis (Ct), Ureaplasma urealyticum, Neisseria gon-orrhoeae, herpes simplex virus types 1 and 2 (HSV-1/2), and human papillomavirus (HPV)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Butirprost and antibiotic; The treatment schedule was based on fluoroquinolone (levofloxacin, 1 tablet 500 mg daily for 4 weeks) plus 1 tablet of Butirprost® daily for 4 weeks	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.; Other Names: Butirprost®; Drug: Levofloxacin 500mg; Treatment typically involves fluoroquinolones alone, such as levofloxacin.
Active Comparator: Antibiotic; the treatment schedule was based on oral fluoroquinolone only (levofloxacin, 1 tablet 500 mg daily for 4 weeks)	Drug: Levofloxacin 500mg; Treatment typically involves fluoroquinolones alone, such as levofloxacin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Assessing the National Institute of Health-Chronic Prostatitis Symptom Index (0-31) and its pain subset at 15- and 30 days (lower scores mean better outcomes).	30 days
Change in urinary symptoms	Assessing the National Institute of Health-Chronic Prostatitis Symptom Index (0-31) and its urinary subset at 15- and 30 days (lower scores mean better outcomes).	30 days
Change in Quality of Life (QoL)	Assessing the National Institute of Health-Chronic Prostatitis Symptom Index (0-31) its subsets at 15- and 30 days (lower scores mean better outcomes).	30 days
Change in Quality of Life (QoL)	Assessing the International Prostatic Symptoms Score (0-35) and its subsets at 15- and 30 days (lower scores mean better outcomes).	30 days

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 9, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: IPSS; QoL; LUTS; Hyaluronic acid; BACTERIAL PROSTATITIS; ANTIBIOTICS
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Male Urogenital Diseases; Inflammation; Prostatitis; Prostatic Diseases; Anti-Bacterial Agents; Anti-Infective Agents; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Topoisomerase Inhibitors; Topoisomerase II Inhibitors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Hyaluronic Acid; Levofloxacin
• Other Study ID Numbers: 156.2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No