Unique ID issued by UMIN | UMIN000001423 |
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Receipt number | R000001697 |
Scientific Title | Randomized clinical study of silodosin vs propiverine for men aged 50 or older with overactivebladder and 20 to 30ml of prostate volume |
Date of disclosure of the study information | 2008/10/14 |
Last modified on | 2010/11/09 11:58:42 |
Randomized clinical study of silodosin vs propiverine for men aged 50 or older with overactivebladder and 20 to 30ml of prostate volume
RCT of silodosin vs propiverine for men aged 50 or older
Randomized clinical study of silodosin vs propiverine for men aged 50 or older with overactivebladder and 20 to 30ml of prostate volume
RCT of silodosin vs propiverine for men aged 50 or older
Japan |
Overactive bladder
Urology |
Others
NO
To investigate effect and safety of silodosin and propiverine
Safety,Efficacy
Confirmatory
Not applicable
Proportion of patients who need treatment change or discontinuation within 8 weeks
OABSS, I-PSS total score, QoL index, voiding/storage subscore, maximal flow rate, postvoid residual urine volume (PVR), the ratio of patients with increasing PVR and adverse effect
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as a block.
YES
Pseudo-randomization
2
Treatment
Medicine |
Silodosin (4mg) 1 Capsule or Silodosin (2mg) 2 Capsules 2x1 after breakfast and dinner daily, orally
Propiverine (10mg) 1x1 after breakfast daily, orally
50 | years-old | <= |
Not applicable |
Male
1) Men are aged 50 or older.
2) Prostate volume is 20ml or greater and less than 30ml by ultrasonography.
3) Overactive bladder is indicated by OABSS: urgency score 2 or greater and total score 5 or greater
4) Postvoid residual urine is 50ml or less.
1) Primary angle-closure glaucoma
2) Obstructive intestinal disease, paralytic ileus, gastrointerstinal atony, myastania gravis, severe heart disease
3) Cognitive disturbance
4) Active urinary tract infection
5) Past history of bladder and/or prostate surgery
6) Past history of bladder and/or prostate cancer
7) Treatment for benign prostate hyperplasia and/or overactive bladder within 3 months
8) Apparent neurological disease
9) judged as being unsuitable for the trial by the researcher
120
1st name | |
Middle name | |
Last name | Yoko Ishida |
National Center for Geriatrics & Gerontology
Division of Urology
36-3, Gengo Morioka-cho Obu Aichi, Japan
0562-46-2311
1st name | |
Middle name | |
Last name | Kikuo Okamura |
National Center for Geriatrics & Gerontology
Division of Urology, Department of Surgery & Intensive Care
36-3, Gengo Morioka-cho Obu Aichi, Japan
0562-46-2311
kokamura@ncgg.go.jp
National Center for Geriatrics & Gerontology
National Center for Geriatrics & Gerontology
Self funding
NO
2008 | Year | 10 | Month | 14 | Day |
Unpublished
Terminated
2008 | Year | 04 | Month | 23 | Day |
2008 | Year | 10 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 06 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2008 | Year | 10 | Month | 09 | Day |
2010 | Year | 11 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001697
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