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 - 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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)
- Sponsor
- Hirosaki University
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(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.
Outcomes
Primary Outcomes
Not specified