The Role of Butirprost® as an Adjuvant in Enhancing the Effect of Antibiotics in Patients Affected by Chronic Bacterial Prostatitis: A Randomized Prospective Trial
Overview
- Phase
- Phase 3
- Intervention
- Sodium Hyaluronate
- Conditions
- Prostate Inflammation
- Sponsor
- Federico II University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in pain
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Benito Fabio Mirto
Principal Investigator
Federico II University
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)
Arms & Interventions
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
Intervention: Sodium Hyaluronate
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
Intervention: Levofloxacin 500mg
Antibiotic
the treatment schedule was based on oral fluoroquinolone only (levofloxacin, 1 tablet 500 mg daily for 4 weeks)
Intervention: Levofloxacin 500mg
Outcomes
Primary Outcomes
Change in pain
Time Frame: 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
Time Frame: 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)
Time Frame: 30 days
Assessing the International Prostatic Symptoms Score (0-35) and its subsets at 15- and 30 days (lower scores mean better outcomes).