Clinical trial NCT00919893: Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
Official title: Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Keywords: chronic prostatitis symptom index
male
inflammatory
CP-CPPS
Cernilton
pelvic pain
symptoms
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Strathmann AG&Co, Hamburg, Germany
name: Cernelle, Ängelholm, Sweden
First posted: 2009-06-12
Enrollment: 139
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
timeFrame: 0, 6, 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 0, 6, 12 weeks
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Justus-Liebig-University
Study officials:
affiliation: Clinic for Urology and Pediatric Urology, Justus-Liebig-University Giessen, Germany
name: Wolfgang Weidner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rugendorff EW, Weidner W, Ebeling L, Buck AC. Results of treatment with pollen extract (Cernilton N) in chronic prostatitis and prostatodynia. Br J Urol. 1993 Apr;71(4):433-8. doi: 10.1111/j.1464-410x.1993.tb15988.x.