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®)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Bacterial Prostatitis
• Intervention / Treatment: Drug: Third generation fluoroquinolone; Dietary supplement: Nutritional supplement + third generation fluoroquinolone

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00161
    • policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A, antibiotics; Prulifloxacin 600 mg	Drug: Third generation fluoroquinolone; Prulifloxacin 600 mg
Active Comparator: Group B, antibiotics plus nutraceuticals; Prulifoxacin plus Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg	Dietary supplement: Nutritional supplement + third generation fluoroquinolone; Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meares-Stamey evaluation	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.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI)	The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) is a questionnaire with 13 questions developed to evaluate symptoms and quality of life in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Every question has a score differing by the answer, and the questionnaire has a total score ranging from 0 to 43. The score is divided by three subscales: pain (score range 0-21), urinary symptoms (score range 0-10) and quality of life (QoL) (score range 0-12). The sum of all single scores is the total score. The reason every item has a different maximum score is because they have a different potential. NIH-CPSI characteristics are: good reliability, validity, and responsiveness to change. It has been used in many large-scale trials regarding CP/CPPS as the primary outcome variable [14].	up to 6 months

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Director: Ettore De Berardinis, Professor, policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 2, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Estimate): May 5, 2014
• Last Update Submitted That Met QC Criteria: May 2, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases; Prostatitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Fluoroquinolones
• Other Study ID Numbers: 1611380961111745