Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Chronic Bacterial Prostatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02130713
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Ettore De Berardinis, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment Phase
Chronic Bacterial Prostatitis Drug: Third generation fluoroquinolone Dietary Supplement: Nutritional supplement + third generation fluoroquinolone Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronic Bacterial Prostatitis: Efficacy of Short-lasting Antibiotic Therapy With Prulifloxacin (Unidrox®) in Association With Saw Palmetto Extract, Lactobacillus Sporogens and Arbutin (Lactorepens®)
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Arbutin

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) [ Time Frame: up to 6 months ]
    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].



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130713


Locations
Layout table for location information
Italy
policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
Roma, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Layout table for investigator information
Study Director: Ettore De Berardinis, Professor Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ettore De Berardinis, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02130713     History of Changes
Other Study ID Numbers: 1611380961111745
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatitis
Prostatic Diseases
Genital Diseases, Male
Anti-Bacterial Agents
Fluoroquinolones
Prulifloxacin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents