Unique ID issued by UMIN | UMIN000019289 |
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Receipt number | R000022306 |
Scientific Title | What are the factors contributing to failure in improvement of subjective symptoms following silodosin administration in patients with benign prostatic hyperplasia? Investigation using a pressure-flow study. |
Date of disclosure of the study information | 2015/10/09 |
Last modified on | 2015/10/09 00:44:21 |
What are the factors contributing to failure in improvement of subjective symptoms following silodosin administration in patients with benign prostatic hyperplasia? Investigation using a pressure-flow study.
Factors contributing to a failure in subjective improvement following alpha-blocker administration
What are the factors contributing to failure in improvement of subjective symptoms following silodosin administration in patients with benign prostatic hyperplasia? Investigation using a pressure-flow study.
Factors contributing to a failure in subjective improvement following alpha-blocker administration
Japan |
Benign prostate hyperplasia
Urology |
Others
NO
To investigate the factors responsible for failure in improvement of subjective symptoms following silodosin treatment on the basis of findings of a pressure-flow study
Efficacy
Exploratory
Pragmatic
Phase IV
To compare patient background and objective findings from PFS performed at baseline and post-treatment between good and poor responders in symptom improvement.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
a silodosin capsule 4 mg twice daily (8 mg/day) for 4 weeks
50 | years-old | <= |
Not applicable |
Male
1) an IPSS total score of 8 or greater; 2) an IPSS-quality of life (QOL) score of 3 or greater; 3) prostate volume measured by transabdominal or transrectal echography of 20 mL or greater; 4) maximum flow rate (Qmax) by uroflowmetry (UFM) of less than 15 mL/sec at a voiding volume of greater than 100 mL; 5) post-void residual urine volume (PVR) of less than 150 mL; and 6) age of 50 years or older.
Patients currently receiving alpha-blockers, anticholinergic drugs, antidepressants, antianxiety drugs and/or sex hormones, those with suspected prostate cancer, neurovesical dysfunction, bladder stone or active urinary tract infection were excluded. Patients with any serious cardiac complication, renal complication (serum creatinine of 2 mg/dl or greater) or hepatic complication (AST and ALT that are at least double the reference values) were also excluded.
100
1st name | |
Middle name | |
Last name | Yoshihisa Matsukawa |
Nagoya University Graduate School of Medicine
Department of Urology
65 Tsurumai, Showa-ku, Nagoya
+81-52-744-2985
yoshi44@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshihisa Matsukawa |
Nagoya University Graduate School of Medicine
Department of Urology
65 Tsurumai, Showa-ku, Nagoya
+81-52-744-2985
yoshi44@med.nagoya-u.ac.jp
Department of Urology
Nagoya University Graduate School of Medicine
Department of Urology
Nagoya University Graduate School of Medicine
Self funding
Japan
NO
名古屋大学医学部附属病院
2015 | Year | 10 | Month | 09 | Day |
Published
The findings suggest that insufficient improvement in storage function is a contributing factor to a failure in subjective improvement after silodosin treatment in patients with BPH.
Completed
2009 | Year | 09 | Month | 01 | Day |
2009 | Year | 10 | Month | 01 | Day |
2012 | Year | 12 | Month | 31 | Day |
2013 | Year | 01 | Month | 31 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 04 | Month | 30 | Day |
2015 | Year | 10 | Month | 09 | Day |
2015 | Year | 10 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022306
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