Treatment of Chronic Bacterial Prostatitis

NCT02130713 | Completed Phase 4

• 1 other identifier: 1611380961111745
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Bacterial Prostatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• NIH-Chronic Prostatitis Symptom Index (NIH-CPSI)

  up to 6 months

Study Arms (2)

Group A, antibiotics

ACTIVE COMPARATOR

Prulifloxacin 600 mg

Drug: Third generation fluoroquinolone

Group B, antibiotics plus nutraceuticals

ACTIVE COMPARATOR

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

Dietary Supplement: Nutritional supplement + third generation fluoroquinolone

Interventions

Third generation fluoroquinolone DRUG

Prulifloxacin 600 mg

Group A, antibiotics

Nutritional supplement + third generation fluoroquinolone DIETARY_SUPPLEMENT

Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg

Group B, antibiotics plus nutraceuticals

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients affected by chronic bacterial prostatitis
• positivity to the Meares-Stamey test
• symptoms duration \> 3 months (dysuria, pelvic pain and/or discomfort)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences

Roma, Roma, 00161, Italy

Location

Related Publications (1)

• 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.

  PMID: 25038794 DERIVED

MeSH Terms

Conditions

Prostatitis

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ettore De Berardinis, Professor

  Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 5, 2014
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: May 5, 2014

Record last verified: 2014-05

Locations

IT (1)