A Phase 3 interventional study of Sodium Hyaluronate and Levofloxacin 500mg in Prostate Inflammation, Prostate Disease and Chronic Bacterial Prostatitis, sponsored by Federico II University. Completed at 1 site in Italy. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Federico II University · Phase 3, Interventional, and 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).
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Sodium Hyaluronate · Drug: Levofloxacin 500mg
the treatment schedule was based on oral fluoroquinolone only (levofloxacin, 1 tablet 500 mg daily for 4 weeks)
Drug: Levofloxacin 500mg
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.
Also known as: Butirprost®
Treatment typically involves fluoroquinolones alone, such as levofloxacin.
Change in pain
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).
Time frame: 30 days
Change in urinary symptoms
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).
Time frame: 30 days
Change in Quality of Life (QoL)
Assessing the National Institute of Health-Chronic Prostatitis Symptom Index (0-31) its subsets at 15- and 30 days (lower scores mean better outcomes).
Time frame: 30 days
Change in Quality of Life (QoL)
Assessing the International Prostatic Symptoms Score (0-35) and its subsets at 15- and 30 days (lower scores mean better outcomes).
Time frame: 30 days
Ran from Mar 2024 to primary completion in Jul 2024, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hyaluronic Acid