Chronic Bacterial ProstatitisPhase 4NCT02130713
Treatment of Chronic Bacterial Prostatitis
A Phase 4 study testing Third generation fluoroquinolone and Nutritional supplement + third generation fluoroquinolone in people with Chronic Bacterial Prostatitis, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Background - bacterial prostatitis (BP) is a common condition accounting responsible for about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type II, are less common but is a condition that significantly hampers the quality of life, (QoL) because not only is it a physical condition… Read more about this study
- Who is it for?
- Ages 19 to 54 years, men only
- Conditions the study is for
- Chronic Bacterial Prostatitis
- What is being tested?
- Third generation fluoroquinolone and Nutritional supplement + third generation fluoroquinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 4
- 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 19 to 54 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- patients affected by chronic bacterial prostatitis
- positivity to the Meares-Stamey test
- symptoms duration > 3 months (dysuria, pelvic pain and/or discomfort)
Who cannot join
- positivity to Chlamydia trachomatis, Ureaplasma urealiticum, Mycoplasma, Neisseria gonorrhoeae, herpes simplex viruses (HSV 1/2) and human papillomavirus (HPV)
- age less than 18 years
- history of neurological disease, urinary stones or cancer
- allergy to fluoroquinolones
- refusal to sign the informed consent
- incomplete follow-up time.
Trial locations and contacts
1 site in 1 country.
Italy1 site
policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
Roma, Roma, 00161
About this study
Official title: Chronic Bacterial Prostatitis: Efficacy of Short-lasting Antibiotic Therapy With Prulifloxacin (Unidrox®) in Association With Saw Palmetto Extract, Lactobacillus Sporogens and Arbutin (Lactorepens®)
Background - bacterial prostatitis (BP) is a common condition accounting responsible for about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type II, are less common but is a condition that significantly hampers the quality of life, (QoL) because not only is it a physical condition but also a psychological distress. Commonly patients are treated with antibiotics alone, and in particular fluoroquinolones are suggested by the European Urology guidelines. This approach, although recommended, may not be enough. Thus, a multimodal approach to the prolonged antibiotic therapy may be helpful.
Methods - 210 patients affected by chronic bacterial prostatitis were enrolled in the study. All patients were positive to Meares-Stamey test and symptoms duration was > 3 months. The purpose of the study was to evaluate the efficacy of a long lasting therapy with a fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21 days and an association of Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg for 30 days). Patients were randomized in two groups (A and B) receiving respectively antibiotic alone and an association of antibiotic plus supplement.
- Conditions
- Chronic Bacterial Prostatitis
- Being tested
- Third generation fluoroquinolone, Nutritional supplement + third generation fluoroquinolone
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third generation fluoroquinoloneDrug
Prulifloxacin 600 mg
Nutritional supplement + third generation fluoroquinoloneDietary supplement
Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A, antibiotics | Active comparator | Prulifloxacin 600 mg Receives: Drug: Third generation fluoroquinolone |
| Group B, antibiotics plus nutraceuticals | Active comparator | Prulifoxacin plus Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg Receives: Dietary Supplement: Nutritional supplement + third generation fluoroquinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meares-Stamey evaluation
The Meares-Stamey test, also known as 4-glass test, is the standard method of assessing inflammation and presence of bacteria in the lower urinary tract of men presenting CBP. The test has been performed on each patient before and after the therapy. The Meares-Stamey evaluation allows the collection of four samples: first voided urine (VB1) that represents urethra, mid-stream urine (VB2) that represents bladder, expressed prostatic secretion (EPS) and post-prostatic massage urine (VB3) that represent the prostate. It is considered positive when we have urophathogen colony-forming units (CFU)/mL ≥103.
Measured: up to 6 months
Secondary outcomes (1)
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI)
The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) is a questionnaire with 13 questions developed to evaluate symptoms and quality of life in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Every question has a score differing by the answer, and the questionnaire has a total score ranging from 0 to 43. The score is divided by three subscales: pain (score range 0-21), urinary symptoms (score range 0-10) and quality of life (QoL) (score range 0-12). The sum of all single scores is the total score. The reason every item has a different maximum score is because they have a different potential. NIH-CPSI characteristics are: good reliability, validity, and responsiveness to change. It has been used in many large-scale trials regarding CP/CPPS as the primary outcome variable [14].
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Bacterial ProstatitisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ettore De Berardinis, University of Roma La Sapienza
- Investigators
- Ettore De Berardinis, Professor, Study director, Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130713
- Sponsor's protocol ID
- 1611380961111745
- Status last verified
- May 2014
- First submitted
- 30 Apr 2014
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Busetto GM, Giovannone R, Ferro M, Tricarico S, Del Giudice F, Matei DV, De Cobelli O, Gentile V, De Berardinis E. Chronic bacterial prostatitis: efficacy of short-lasting antibiotic therapy with prulifloxacin (Unidrox(R)) in association with saw palmetto extract, lactobacillus sporogens and arbutin (Lactorepens(R)). BMC Urol. 2014 Jul 19;14:53. doi: 10.1186/1471-2490-14-53.
PubMed 25038794
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Bacterial Prostatitis: Efficacy of Short-lasting Antibiotic Therapy With Prulifloxacin (Unidrox®) in Association With Saw Palmetto Extract, Lactobacillus Sporogens and Arbutin (Lactorepens®)
- ClinicalTrials.gov ID
- NCT02130713
- Acronym / sponsor ID
- 1611380961111745
- Conditions
- Chronic Bacterial Prostatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 May 2014 (estimated)
- 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.
Background - bacterial prostatitis (BP) is a common condition accounting responsible for about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type II, are less common but is a condition that significantly hampers the quality of life, (QoL) because not only is it a physical condition but also a psychological distress. Commonly patients are treated with antibiotics alone, and in particular fluoroquinolones are suggested by the European Urology guidelines. This approach, although recommended, may not be enough. Thus, a multimodal approach to the prolonged antibiotic therapy may be helpful.
Methods - 210 patients affected by chronic bacterial prostatitis were enrolled in the study. All patients were positive to Meares-Stamey test and symptoms duration was > 3 months. The purpose of the study was to evaluate the efficacy of a long lasting therapy with a fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21 days and an association of Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg for 30 days). Patients were randomized in two groups (A and B) receiving respectively antibiotic alone and an association of antibiotic plus supplement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, antibiotics | Active comparator | Drug: Third generation fluoroquinolonePrulifloxacin 600 mg |
| Group B, antibiotics plus nutraceuticals | Active comparator | Dietary Supplement: Nutritional supplement + third generation fluoroquinolonePrulifoxacin plus Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients affected by chronic bacterial prostatitis
- positivity to the Meares-Stamey test
- symptoms duration > 3 months (dysuria, pelvic pain and/or discomfort)
Key exclusion criteria (6 listed)
- positivity to Chlamydia trachomatis, Ureaplasma urealiticum, Mycoplasma, Neisseria gonorrhoeae, herpes simplex viruses (HSV 1/2) and human papillomavirus (HPV)
- age less than 18 years
- history of neurological disease, urinary stones or cancer
- allergy to fluoroquinolones
- refusal to sign the informed consent
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 |
|---|---|---|
| Third generation fluoroquinolonePrulifloxacin 600 mg | Drug | Group A, antibiotics |
| Nutritional supplement + third generation fluoroquinoloneSerenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg | Dietary supplement | Group B, antibiotics plus nutraceuticals |
Primary outcome
Meares-Stamey evaluation
Time frame: up to 6 months
The Meares-Stamey test, also known as 4-glass test, is the standard method of assessing inflammation and presence of bacteria in the lower urinary tract of men presenting CBP. The test has been performed on each patient before and after the therapy. The Meares-Stamey evaluation allows the collection of four samples: first voided urine (VB1) that represents urethra, mid-stream urine (VB2) that represents bladder, expressed prostatic secretion (EPS) and post-prostatic massage urine (VB3) that represent the prostate. It is considered positive when we have urophathogen colony-forming units (CFU)/mL ≥103.
1 secondary outcome
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI)
Time frame: up to 6 months
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 5 May 2014.
- Derived from this study: PubMed 25038794Busetto GM, Giovannone R, Ferro M, Tricarico S, Del Giudice F, Matei DV, De Cobelli O, Gentile V, De Berardinis E. Chronic bacterial prostatitis: efficacy of short-lasting antibiotic therapy with prulifloxacin (Unidrox(R)) in association with saw palmetto extract, lactobacillus sporogens and arbutin (Lactorepens(R)). BMC Urol. 2014 Jul 19;14:53. doi: 10.1186/1471-2490-14-53.
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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.
Ettore De Berardinis, Professor study director
Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Third generation fluoroquinolone and Nutritional supplement + third generation fluoroquinolone in people with Chronic Bacterial Prostatitis, run by University of Roma La Sapienza 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 6 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 5 May 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Meares-Stamey evaluation (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02130713, which also lists 1 linked publication.
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 5 May 2014.