Chronic Bacterial Prostatitis: Efficacy of Short-lasting Antibiotic Therapy With Prulifloxacin (Unidrox®) in Association With Saw Palmetto Extract, Lactobacillus Sporogens and Arbutin (Lactorepens®)
Overview
- Phase
- Phase 4
- Intervention
- Third generation fluoroquinolone
- Conditions
- Chronic Bacterial Prostatitis
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Meares-Stamey evaluation
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Ettore De Berardinis
Professor
University of Roma La Sapienza
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.
Arms & Interventions
Group A, antibiotics
Prulifloxacin 600 mg
Intervention: Third generation fluoroquinolone
Group B, antibiotics plus nutraceuticals
Prulifoxacin plus Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg
Intervention: Nutritional supplement + third generation fluoroquinolone
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- NIH-Chronic Prostatitis Symptom Index (NIH-CPSI)(up to 6 months)