Chronic Pelvic Pain Syndrome, Chronic Prostatitis
Conditions
Keywords
chronic prostatitis symptom index, male, inflammatory, CP-CPPS, Cernilton, pelvic pain, symptoms
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.
Interventions
DRUGCernilton
Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 23 mg Extractum Pollens siccatum, 4 mg L-glutamate and 0.23 mg Stigmasterol per capsule for 12 weeks.
DRUGPlacebo
Oral placebo, 2 capsules every 8 hours with identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
Sponsors
Strathmann AG&Co, Hamburg, Germany
Cernelle, Ängelholm, Sweden
University of Giessen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Participant flow
Recruitment details
Outpatients at urologic clinics. Start date: December 1999. Stop date: January 2004.
Participants by arm
| Arm | Count |
|---|---|
| Cernilton Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks. | 70 |
| Placebo Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks. | 69 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 19 | 9 |
Baseline characteristics
| Characteristic | Placebo | Cernilton | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 70 Participants | 139 Participants |
| Age, Continuous | 39.3 years STANDARD_DEVIATION 9.1 | 39.7 years STANDARD_DEVIATION 7.2 | 39.5 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment Germany | 69 participants | 70 participants | 139 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 69 Participants | 70 Participants | 139 Participants |
Outcome results
Primary
Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.
Time frame: 0, 6, 12 weeks
Population: ITT (Intention to treat) LOCF (Last observation carried forward)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cernilton | Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | 47 participants |
| Placebo | Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) | 33 participants |
Comparison: Null hypothesis: Cernilton compared to placebo induces a better or the same outcome of symptomatic improvement in the pain domain of symptomatic Pelvic Pain Syndrome verified by the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).~Power calculation: A power of 1-beta=0.8 was calculated.p-value: <0.05t-test, 2 sided
Secondary
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.
Decrease of score points. Decrease of leucocytes in urine.
Time frame: 0, 6, 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cernilton | 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. | 47 participants |
| Placebo | 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. | 33 participants |