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

NCT06684626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-18

No results posted yet for this 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).

Conditions

  • Prostate Inflammation
  • Prostate Disease
  • Chronic Bacterial Prostatitis

Interventions

DRUG

Sodium Hyaluronate

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.

DRUG

Levofloxacin 500mg

Treatment typically involves fluoroquinolones alone, such as levofloxacin.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-07-31
Completion
2024-09-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06684626 on ClinicalTrials.gov