Treatment of Chronic Bacterial Prostatitis

Chronic Bacterial Prostatitis Clinical Trial

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130713
• Other study ID #: 1611380961111745
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2014
• Last updated: May 2, 2014
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 54 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Bacterial Prostatitis
• Prostatitis

Intervention

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

Locations

Country	Name	City	State
Italy	policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No