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

Last updated: November 13, 2024
Sponsor: Federico II University
Overall Status: Completed

Phase

3

Condition

Soft Tissue Infections

Gynecological Infections

Sexually Transmitted Diseases (Stds)

Treatment

Levofloxacin 500mg

Sodium Hyaluronate

Clinical Study ID

NCT06684626
156.2023
  • Ages 18-50
  • Male

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patient aged between 18 and 50 years

  • symptoms consistent with CBP

  • positive Mears-Stamey test

Exclusion

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 thestudy

  • 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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Levofloxacin 500mg
Phase: 3
Study Start date:
March 01, 2024
Estimated Completion Date:
September 01, 2024

Connect with a study center

  • University of Naples Federico II

    Napoli, 80131
    Italy

    Site Not Available

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