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Treatment of Chronic Bacterial Prostatitis

NCT02130713 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2014-05-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Ettore De Berardinis, Professor · Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-12-31
Completion
2013-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02130713 on ClinicalTrials.gov