A randomized prospective study to determine the effectiveness and safety of Eviprostat to treat chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)in comparison with pollen extract
- Conditions
- chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)
- Registration Number
- JPRN-UMIN000019618
- Lead Sponsor
- Hirosaki University
- Brief Summary
In the intention-to-treat analysis, 100 men were randomly allocated to Eviprostat (n =50) or the pollen extract (n = 50). Response (defined as a decrease in the NIH-CPSI total score by at least 25%) in the Eviprostat group and the pollen extract group was 88.2% and 78.1%, respectively. There was no significant difference in the total, pain, urinary and quality of life (QOL) scores of the NIH-CPSI between the two groups at 8weeks. This was also the case with the total, voiding, and storage symptoms of the IPSS. There were no severe adverse events observed in any patients in this study. Both the pollen extract and Eviprostat significantly reduced the symptoms of category III CP/CPPS without any adverse events. Eviprostat has an identical effect on category III CP/CPPS compared the pollen extract.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 100
Not provided
(1) documented urinary tract infection (midstream urine culture with at least 100,000 colony-forming units per milliliter), (2) history of urethritis, epididymitis or sexually transmitted disease (STD) (3) history of prostate surgery (4)history of urogenital cancer (5) treatment with phytotherapeutic agents, a-blocker agents, or antimicrobials.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Participants were evaluated using the NIH-CPSI and the International Prostate Symptom Score (IPSS) at baseline and after 4 and 8 weeks.
- Secondary Outcome Measures
Name Time Method