Prostate Inflammation, Prostate Disease, Chronic Bacterial Prostatitis
Conditions
Keywords
BACTERIAL PROSTATITIS, ANTIBIOTICS, LUTS, QoL, IPSS, Hyaluronic acid
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).
Interventions
DRUGSodium 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.
Treatment typically involves fluoroquinolones alone, such as levofloxacin.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Italy
Outcome results
None listed