Prostate InflammationPhase 3NCT06684626
The Role of Butirprost® in Combination With Antibiotics in Chronic Bacterial Prostatitis (CBP) Treatment
A Phase 3 study testing Sodium Hyaluronate and Levofloxacin 500mg in people with Prostate Inflammation and Prostate Disease, run by Federico II University at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Prostate Inflammation, Prostate Disease, Chronic Bacterial Prostatitis
- What is being tested?
- Sodium Hyaluronate and Levofloxacin 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 1 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- patient aged between 18 and 50 years
- symptoms consistent with CBP
- positive Mears-Stamey test
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
- Being tested
- Sodium Hyaluronate, Levofloxacin 500mg
- Keywords
- BACTERIAL PROSTATITIS, ANTIBIOTICS, LUTS, QoL, IPSS, Hyaluronic acid
- Medical subject headings
- Prostatitis, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HyaluronateDrug
Also called 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 500mgDrug
Treatment typically involves fluoroquinolones alone, such as levofloxacin.
| Study group | Role | What they receive |
|---|---|---|
| Butirprost and antibiotic | Experimental | 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 Receives: Drug: Sodium Hyaluronate; Drug: Levofloxacin 500mg |
| Antibiotic | Active comparator | the treatment schedule was based on oral fluoroquinolone only (levofloxacin, 1 tablet 500 mg daily for 4 weeks) Receives: Drug: Levofloxacin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Mar 2024
- Primary completion31 Jul 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate InflammationStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benito Fabio Mirto, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684626
- Sponsor's protocol ID
- 156.2023
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06684626
- Acronym / sponsor ID
- 156.2023
- Keywords
- BACTERIAL PROSTATITIS, ANTIBIOTICS, LUTS, QoL, IPSS, Hyaluronic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butirprost and antibiotic | Experimental | Drug: Sodium Hyaluronate, Drug: Levofloxacin 500mgThe 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 500mgthe treatment schedule was based on oral fluoroquinolone only (levofloxacin, 1 tablet 500 mg daily for 4 weeks) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patient aged between 18 and 50 years
- symptoms consistent with CBP
- positive Mears-Stamey test
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium HyaluronateAlso: 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. | Drug | Butirprost and antibiotic |
| Levofloxacin 500mgTreatment typically involves fluoroquinolones alone, such as levofloxacin. | Drug | Antibiotic, Butirprost and antibiotic |
Primary outcome
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Hyaluronate and Levofloxacin 500mg in people with Prostate Inflammation and Prostate Disease, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.