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

NCT06684626 | Completed Phase 3

• 1 other identifier: 156.2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BACTERIAL PROSTATITIS; ANTIBIOTICS; LUTS; QoL; IPSS; Hyaluronic acid

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Butirprost and antibiotic

EXPERIMENTAL

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; Drug: Levofloxacin 500mg

Antibiotic

ACTIVE COMPARATOR

the treatment schedule was based on oral fluoroquinolone only (levofloxacin, 1 tablet 500 mg daily for 4 weeks)

Drug: Levofloxacin 500mg

Interventions

Sodium Hyaluronate DRUG

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.

Also known as: Butirprost®

Butirprost and antibiotic

Levofloxacin 500mg DRUG

Treatment typically involves fluoroquinolones alone, such as levofloxacin.

Antibiotic; Butirprost and antibiotic

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Prostatitis; Prostatic Diseases

Interventions

Hyaluronic Acid; Levofloxacin

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: March 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: September 1, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

IT (1)