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Prostatitis Foundation

Third International Chronic Prostatitis Network

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study Of Antibiotics For The Treatment Of Category Iiib Chronic Pelvic Pain Syndrome In Men

J. Dimitrakov, J. Tchitalov, T. Zlatanov, D. Dikov
Justus-Liebig University, Urology Clinic, 29 Klinikstrasse, Giessen, Germany and Higher Medical Institute, Departments of Urology and Pathology, 15 A Vassil Aprilov Str, Plovdiv, Bulgaria
Chronic pelvic pain (category IIIB) is a frustrating clinical entity to both patients and clinicians alike. As recently detailed by an expert in the field, many researchers feel that the majority of patients do, in fact, have a microbial etiology for their disease, but that urologists are just not culturing the correct organism. Others feel that the majority of cases, especially those in patients with no demonstrable inflammation, do not have a microbial etiology. To complicate things further, many asymptomatic patients in whom a diagnosis of chronic prostatitis has not been made have had both inflammation and microorganisms identified in prostate-specific specimens.
Primary end-point:
Evaluation of long-term (six- and eighteen-month) antibiotic safety and efficacy.
Secondary end-points:
Evidence for improvement in EPS and PPMU of inflammatory (cytokine profile-based) parameters.
Material and Methods:
One hundred male patients (median age 21, range 18-45) who met the criteria for category IIIB were enrolled in the study. Patients were randomized to receive either Ciprofloxacin 500 mg bid (or placebo) for 6 weeks in combination with prostatic massage. None of the patients had received antibiotics during the preceding 8 weeks. Patients were meticulously evaluated using the Meares and Stamey four-glass technique plus a urethral swab. Samples were cultured for bacteria aerobically on blood sheep and McConkey agar for 1 week and on Sabouraud's media for detection of fungal growth for 30 days. Thereafter, frozen samples were evaluated for presence of bacterial signal using the 16S rRNA detection kit (Qiagen, Valencia, CA), the Roche CT/NG Amplicor Assay (Roche Molecular Systems, Branchburg, NJ) and LCR (Abbott Laboratories, Abbott Park, Chicago, IL) and nested Mycoplasma-specific as well as Mycoplasma genitalium-specific protocols. Inflammatory activity was evaluated using commercial ELISA kits.
By definition, all patients had negative microbiological results.

CIPRO 53 % 21 % 3 % 65 %
PLACEBO 69 % 18 % 5 % 9 %
The results of our study show that antibiotics have an unacceptably high rate of adverse side effects as well as a statistically insignificant improvement over placebo and should be avoided in Category IIIB CPPS patients with negative PCR findings for the presence of bacteria.
Supported by Commercial League-National Pharma Center - Bulgaria and Bayer Ltd - Bulgaria

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