Treatment of Chronic Bacterial Prostatitis

University of Roma La Sapienza

Status and phase: Completed; Phase 4

Conditions: Chronic Bacterial Prostatitis

Treatments: Dietary Supplement: Nutritional supplement + third generation fluoroquinolone; Drug: Third generation fluoroquinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02130713

1611380961111745

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: Male

Ages: 19 to 54 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Group A, antibiotics

Active Comparator group

Description:

Prulifloxacin 600 mg

Treatment:

Drug: Third generation fluoroquinolone

Group B, antibiotics plus nutraceuticals

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Nutritional supplement + third generation fluoroquinolone