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

NCT06684626 — Phase 3, Completed, 60 participants, Federico II University

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

Registry	NCT06684626
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Actual)
Sponsor	Federico II University (Other)
Conditions	Prostate Inflammation, Prostate Disease, Chronic Bacterial Prostatitis
Interventions	Sodium Hyaluronate, Levofloxacin 500mg (Drug)
Dates	start 2024-03-01, primary completion 2024-07-31, completion 2024-09-01, first posted 2024-11-12, last updated 2024-11-18
Locations	1 site in Italy

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Butirprost and antibiotic	Experimental	Drug: Sodium Hyaluronate; Drug: 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	Active comparator	Drug: Levofloxacin 500mg	the treatment schedule was based on oral fluoroquinolone only (levofloxacin, 1 tablet 500 mg daily for 4 weeks)

Sodium Hyaluronate (Drug), also known as Butirprost®: 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.
Levofloxacin 500mg (Drug): Treatment typically involves fluoroquinolones alone, such as levofloxacin.

+Outcome measures

Primary outcomes

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 National Institute of Health-Chronic Prostatitis Symptom Index (0-31) its subsets 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).

+Eligibility

Sex: Male, ages: 18 Years to 50 Years

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)

+Locations (1)

Facility	City	Country	Status
University of Naples Federico II	Naples	Italy