NCT02130713

Treatment of Chronic Bacterial Prostatitis

Chronic Bacterial Prostatitis: Efficacy of Short-lasting Antibiotic Therapy With Prulifloxacin (Unidrox®) in Association With Saw Palmetto Extract, Lactobacillus Sporogens and Arbutin (Lactorepens®)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: Male
• Age: 19 Years – 54 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Third generation fluoroquinolone	Prulifloxacin 600 mg
DIETARY_SUPPLEMENT	Nutritional supplement + third generation fluoroquinolone	Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2014-05-05
• Last updated: 2014-05-05

Locations

1 site across 1 country: Italy