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

Phase 3

Completed

• Conditions: Prostate Inflammation; Prostate Disease; Chronic Bacterial Prostatitis
• Interventions: Drug: Sodium Hyaluronate; Drug: Levofloxacin 500mg

• Registration Number: NCT06684626
• Lead Sponsor: Federico II University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-09-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-09
• Study First Posted: 2024-11-12
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butirprost and antibiotic	Sodium Hyaluronate	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
Butirprost and antibiotic	Levofloxacin 500mg	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
Antibiotic	Levofloxacin 500mg	the treatment schedule was based on oral fluoroquinolone only (levofloxacin, 1 tablet 500 mg daily for 4 weeks)

Primary Outcome Measures

Name	Time	Method
Change in pain	30 days	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).
Change in urinary symptoms	30 days	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).
Change in Quality of Life (QoL)	30 days	Assessing the International Prostatic Symptoms Score (0-35) and its subsets at 15- and 30 days (lower scores mean better outcomes).

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Napoli, Italy