Unique ID issued by UMIN | UMIN000008483 |
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Receipt number | R000009973 |
Scientific Title | Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms |
Date of disclosure of the study information | 2012/09/01 |
Last modified on | 2018/07/25 13:04:08 |
Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Japan |
Benign Prostatic Hyperplasia
Urology |
Others
NO
Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Safety,Efficacy
IPSS Score, QOL Score, Blood pressure
maximum urinary flow rate (Qmax), residual urine volume
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Given the 4 mg once daily silodosin for 12 weeks in patients newly diagnosed with benign prostatic hyperplasia and, since then the 4 mg silodosin twice daily for 12 weeks
Given the 4 mg once daily silodosin for 12 weeks in patients taking another alpha-blocker with benign prostatic hyperplasia, since then the 4 mg silodosin twice daily for 12 weeks
50 | years-old | <= |
80 | years-old | > |
Male
1) Men aged over 50 and under 80 years old
2) International Prostate Symptom Score (IPSS) of>7
3) a prostate volume of >20ml
4) a maximum urinary flow rate (Qmax) of <15ml/s
5) The patients are obtained the informed consent
6) The patients undergone Wash out period 4 weeks or more (switching patients from another alpha-1 blocker)
1) patients are having the disease other than a benign prostatic hyperplasia (prostate cancer, bladder tumors, bladder stones, prostatitis, bladder neck sclerosis, patients, etc.)
2) Patients have received TUR-P, balloon dilation, urethral stent, hyperthermia, or radiation therapy to the pelvis, within 6 months of the start of the study
3) Self-catheterization
4) Patients with urinary tract infection
5) Patients with concomitant disease and other nervous system diseases, and it suspected to be neurogenic bladder
6) Patients with concomitant severe ischemic heart disease, cerebrovascular disease, liver dysfunction, renal dysfunction.
7) Patients with hypotension
8) Patients are having hypersensitivity to silodosin, naftopidil or taking vardenafil hydrochloride
9) Patients have treated with hormonal drug within 6 months
10) Patients treated with drugs other than tamsulosin is considered effective on urinary symptoms within a week
11) Patients was deemed by the physician as inappropriate to attend
200
1st name | |
Middle name | |
Last name | Masato Fujisawa |
Kobe University Graduate School of Medicine
Division of Urology
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
078-382-6155
toshiro@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Toshiro Shirakawa |
Kobe University Graduate School of Medicine
Division of Urology
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
078-382-6155
toshiro@med.kobe-u.ac.jp
Division of Urology, Kobe University Graduate School of Medicine
Department of Urology, Kobe University
Self funding
Hyogo PrefeCtural Awaji Hospital
Miki City Hospital
Kobe Ekisaikai Hospital,
Shakaihoken Kobe Central Hospital
NO
2012 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 07 | Month | 20 | Day |
2018 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009973
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