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

NCT ID: NCT06684626

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Sodium Hyaluronate

Intervention Type: 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.

Levofloxacin 500mg

Intervention Type: DRUG

Treatment typically involves fluoroquinolones alone, such as levofloxacin.

Antibiotic

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

Group Type: ACTIVE_COMPARATOR

Levofloxacin 500mg

Intervention Type: DRUG

Treatment typically involves fluoroquinolones alone, such as levofloxacin.

Interventions

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.

Intervention Type: DRUG

Levofloxacin 500mg

Treatment typically involves fluoroquinolones alone, such as levofloxacin.

Intervention Type: DRUG

Other Intervention Names

Butirprost®

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Benito Fabio Mirto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Naples Federico II

Napoli, , Italy

Countries

Italy

Other Identifiers

156.2023

Identifier Type: -

Identifier Source: org_study_id