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Clinical Trials/JPRN-UMIN000019618
JPRN-UMIN000019618
Completed
未知

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

Hirosaki University0 sites100 target enrollmentNovember 3, 2015

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.

Registry
who.int
Start Date
November 3, 2015
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

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

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