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NCT Number: NCT06684626

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

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).

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Key information

Conditions

Prostate Inflammation Chronic Bacterial Prostatitis Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostate Disease Prostatic Diseases Prostatitis Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sodium Hyaluronate

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.

Other names: Butirprost®

Levofloxacin 500mg

Drug

Treatment typically involves fluoroquinolones alone, such as levofloxacin.

Primary outcomes

  1. 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).

  2. 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).

  3. Change in Quality of Life (QoL)

    Time frame: 30 days

    Assessing the National Institute of Health-Chronic Prostatitis Symptom Index (0-31) its subsets at 15- and 30 days (lower scores mean better outcomes).

  4. 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).

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

The Role of Butirprost® as an Adjuvant in Enhancing the Effect of Antibiotics in Patients Affected by Chronic Bacterial Prostatitis: A Randomized Prospective Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 12, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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