Treatment of Chronic Bacterial Prostatitis

NCT ID: NCT02130713

Last Updated: 2014-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-01-31

Brief 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 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A, antibiotics

Prulifloxacin 600 mg

Group Type: ACTIVE_COMPARATOR

Third generation fluoroquinolone

Intervention Type: DRUG

Prulifloxacin 600 mg

Group B, antibiotics plus nutraceuticals

Prulifoxacin plus Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg

Group Type: ACTIVE_COMPARATOR

Nutritional supplement + third generation fluoroquinolone

Intervention Type: DIETARY_SUPPLEMENT

Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg

Interventions

Third generation fluoroquinolone

Prulifloxacin 600 mg

Intervention Type: DRUG

Nutritional supplement + third generation fluoroquinolone

Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• patients affected by chronic bacterial prostatitis
• positivity to the Meares-Stamey test
• symptoms duration > 3 months (dysuria, pelvic pain and/or discomfort)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Ettore De Berardinis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ettore De Berardinis, Professor

Role: STUDY_DIRECTOR

Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences

Locations

policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences

Roma, Roma, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 25038794 (View on PubMed)

Other Identifiers

1611380961111745

Identifier Type: -

Identifier Source: org_study_id