Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)

Phase 3

Completed

Brief Summary: In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. The purpose of this study is to determine whether Cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.

Detailed Description: We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory CP-CPPS (National Institutes of Health (NIH) type IIIA). Participants were randomized to Cernilton or placebo for 12 weeks and were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) individual domains and total score, the number of leukocytes in post prostatic massage urine, the International Prostate Symptom Score (IPSS) and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 weeks.

Recruitment & Eligibility

Inclusion Criteria

men between 18 and 65 years
symptoms of pelvic pain for at least 3 months during the 6 months before study entry
a score in the pain domain of the German validated version of the NIH chronic prostatitis symptom index (NIH-CPSI) of 7 or higher
leukocytes of 10 or more in post prostate massage urine

Exclusion Criteria

urinary tract infection
acute bacterial or chronic bacterial prostatitis
history of urethritis with discharge 4 weeks prior to study entry
a history of epididymitis or sexually transmitted disease
residual urine volume of more than 50 mL due to bladder outlet obstruction
indication for or history of prostate surgery including prostate biopsy
treatment with phytotherapeutic agents
alpha-blocker agents or antimicrobial substances with prostatic penetration 4 weeks prior to study entry
treatment with agents influencing intraprostatic hormone metabolism 6 months prior to study entry

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
Cernilton	Cernilton	Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)

Primary Outcome Measures

Name	Time	Method
Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)	0, 6, 12 weeks	Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.	0, 6, 12 weeks	Decrease of score points. Decrease of leucocytes in urine.