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Treatment of Chronic Bacterial Prostatitis

Primary Purpose

Chronic Bacterial Prostatitis

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Third generation fluoroquinolone
Nutritional supplement + third generation fluoroquinolone
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Bacterial Prostatitis

Eligibility Criteria

19 Years - 54 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A, antibiotics

Group B, antibiotics plus nutraceuticals

Arm Description

Prulifloxacin 600 mg

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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].

Full Information

First Posted
April 30, 2014
Last Updated
May 2, 2014
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT02130713
Brief Title
Treatment of Chronic Bacterial Prostatitis
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bacterial Prostatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A, antibiotics
Arm Type
Active Comparator
Arm Description
Prulifloxacin 600 mg
Arm Title
Group B, antibiotics plus nutraceuticals
Arm Type
Active Comparator
Arm Description
Prulifoxacin plus Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg
Intervention Type
Drug
Intervention Name(s)
Third generation fluoroquinolone
Intervention Description
Prulifloxacin 600 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplement + third generation fluoroquinolone
Intervention Description
Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg
Primary Outcome Measure Information:
Title
Meares-Stamey evaluation
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
NIH-Chronic Prostatitis Symptom Index (NIH-CPSI)
Description
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].
Time Frame
up to 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ettore De Berardinis, Professor
Organizational Affiliation
Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
Official's Role
Study Director
Facility Information:
Facility Name
policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
City
Roma
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25038794
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment of Chronic Bacterial Prostatitis

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