Clinical trial NCT02130713: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Bacterial Prostatitis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 210
Sex: MALE
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Meares-Stamey evaluation
timeFrame: up to 6 months
Secondary outcomes:
measure: NIH-Chronic Prostatitis Symptom Index (NIH-CPSI)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
Study officials:
affiliation: Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences
name: Ettore De Berardinis, Professor
role: STUDY_DIRECTOR
References:
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.