Unique ID issued by UMIN | UMIN000019618 |
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Receipt number | R000022664 |
Scientific Title | 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 |
Date of disclosure of the study information | 2015/11/03 |
Last modified on | 2015/12/20 09:37:45 |
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
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
Japan |
chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)
Urology |
Others
NO
A randomized prospective study to determine the effectiveness and safety of Eviprostat to treat CP/CPPS in comparison with pollen extract
Safety,Efficacy
Participants were evaluated using the NIH-CPSI and the International Prostate Symptom Score (IPSS) at baseline and after 4 and 8 weeks.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Eviprostat (two capsules, q 8 h) for 8 weeks
pollen extract(two capsules, q 8 h) for 8 weeks
20 | years-old | <= |
80 | years-old | >= |
Male
Inclusion criteria were (1) men between 20 and 80 year of age with symptoms of
pelvic pain for 3 months or more before study (2) Patients with a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score > 15 point (3) Patients diagnosed with NIH category IIIA and IIIB using the PPMT (pre- and post-massage test) .
(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.
100
1st name | |
Middle name | |
Last name | Chikara Ohyama |
Hirosaki University
Urology
5 Zaifucho Hirosaki, Japan
0172-33-5111
coyama@cc.hirosaki-u.ac.jp
1st name | |
Middle name | |
Last name | Yasuhiro Hashimoto |
Hirosaki University
Urology
5 Zaifucho Hirosaki, Japan
0172-33-5111
bikkuri@opal.plala.or.jp
Hirosaki University
none
Other
NO
2015 | Year | 11 | Month | 03 | Day |
Published
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.
Completed
2009 | Year | 05 | Month | 24 | Day |
2009 | Year | 06 | Month | 01 | Day |
2015 | Year | 11 | Month | 03 | Day |
2015 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022664
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