This double-blind, prospective, randomized and multicentre clinical phase 3 study was conducted in 8 Japan urologic centers to ascertain the safety and efficacy of 8-weeks Eviprostat in men diagnosed with inflammatory CP/CPPS.
The design of the study was in accordance with the guidelines for clinical trials in CP/CPPS described by the NIH Chronic Prostatitis Collaborative Research Network.
Inclusion criteria were men between 20 and 80 year of age with symptoms of pelvic pain for 3 months or more before study. Patients with a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥15 point. Patients diagnosed with NIH category IIIA and IIIB using the PPMT (pre- and post-massage test) . Category IIIA refers to the presence of white blood cells (WBC) after a prostate massage urine specimen (VB3) (WBC in VB3>10/hps). Category IIIB refers to patients with pelvic pain with no evidence of inflammation on VB3.
Exclusion criteria were documented urinary tract infection (midstream urine culture with at least 100,000 colony-forming units per milliliter), history of urethritis, epididymitis or sexually transmitted disease (STD) history of prostate surgery history of urogenital cancer treatment with phytotherapeutic agents, a-blocker agents, or antimicrobials. residual urine volume >50 ml resulting from bladder outlet obstruction (BOO).
The study protocol was approved by the ethical committee of Hirosaki University School of Medicine, Aomori, Japan. Written informed consent was obtained from all patients to participation in this study. This study was registered with the Hirosaki University Hospital Clinical Trials Registry in Japan (2009-013) on 24 May 2009 and was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000019618) on 3 November 2015.
We included in our study patients with urinary symptoms who met our inclusion criteria from among patients who had been diagnosed with clinically chronic prostatitis in medical interviews. The significance, objectives, and methods of this clinical study were fully explained to the patients, and their voluntary written informed consent was obtained. The patients' subjective symptoms were evaluated using NIH-CPSI (Japanese version) and International Prostate Symptom Score (IPSS) (Japanese version).[17,18]
We checked patients 1 week after initiating drug therapy to ascertain whether they met the inclusion criteria. Patients were then allocated to receive either Eviprostat [two capsules q8h, with the active substance consisting of the umbellate wintergreen Chimaphila umbellate extract 0.5 mg, the aspen Populus tremula extract 0.5 mg, the small pasque flower Pulsatilla pratensis extract 0.5 mg, the field horsetail Equisetum arvense extract 1.5 mg and germ oil from wheat (Tritium aestivum) 15.0 mg.] or pollen extract (two capsules q8h, with the active substance consisting of 60 mg Cernitin T60 and 3 mg Cernitin GBX) The allocation manager randomly determined which of the 2 drugs would be administered to each patient. Cards detailing the drug to be used were sealed in numbered envelopes and distributed to patients from the smallest number to the largest. The drug to be used was decided on the basis of the card.
We used the SPSS 21.0 software package (SPSS, Chicago, IL) for statistical analyses. Intergroup differences were analyzed by the Student's t-test. Intragroup differences were analyzed by a paired t-test. A value of P<0.05 was considered statistically significant.
BMC Urol. 2015;15(120) © 2015 BioMed Central, Ltd.