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

Federico II University

Status and phase: Completed; Phase 3

Conditions: Prostate Disease; Prostate Inflammation; Chronic Bacterial Prostatitis

Treatments: Drug: Levofloxacin 500mg; Drug: Sodium Hyaluronate

Study type: Interventional

Funder types: Other

Identifiers

NCT06684626

156.2023

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Butirprost and antibiotic

Experimental group

Description:

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

Treatment:

Drug: Levofloxacin 500mg

Drug: Sodium Hyaluronate

Antibiotic

Active Comparator group

Description:

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

Treatment:

Drug: Levofloxacin 500mg