Unique ID issued by UMIN | UMIN000003125 |
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Receipt number | R000003733 |
Scientific Title | CLSS-based assessment of alfa-adrenoceptor blockers for male LUTS (CLAM-STUDY) |
Date of disclosure of the study information | 2010/02/01 |
Last modified on | 2019/02/08 13:11:06 |
CLSS-based assessment of alfa-adrenoceptor blockers for male LUTS (CLAM-STUDY)
CLAM-STUDY
CLSS-based assessment of alfa-adrenoceptor blockers for male LUTS (CLAM-STUDY)
CLAM-STUDY
Japan |
male lower urinary tract symptoms, mLUTS
Urology |
Others
NO
The purpose of the study is to evaluate the efficacy and safety of alfa-adrenoceptor blockers for male lower urinary tract symptoms (mLUTS) using the new CLSS evaluation index and to determine any correlation between CLSS and other conventional evaluation indices (International prostate symptom score (I-PSS) and Overactive baldder symptom score (OABSS)).
Efficacy
Exploratory
Explanatory
Not applicable
Results of treatment with silodosin or tamsulosin hydrochloride evaluated by variations in the new CLSS evaluation index (total score and category-specific score).
I-PSS, OABSS, Uroflowmetry, Residual urine volume, Prostate volume
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Silodosin 8 mg dairy
Tamsulosis 0.2 mg dairy
Not applicable |
Not applicable |
Male
Male patients with newly diagnosed LUTS according to the treatment algorithm of the Clinical Practice Guidelines for Male Lower Urinary Tract Symptoms
Patients who meet any of the following criteria are excluded:
1) Patients taking anticholinergic agents, antidepressants, or antianxiety agents
2) Patients with a history of urinary retention, urinary tract infections, macroscopic haematuria, lower urinary tract surgery, radiotherapy for the pelvic organs, or neurologic disease
3) Patients with pyuria, renal impairment, calculus bladder, or who are urine cytology positive
4) Patients with elevated PSA levels (4.0 ng/mL or over)
5) Patients whose 9th CLSS score is 2 or higher
6) Patients who are not willing to receive drug treatment
7) Patients who cannot answer the questionnaire by themselves
8) Patients classified as ineligible by the investigator
600
1st name | |
Middle name | |
Last name | Yukio Homma |
The University of Tokyo Hospital
Department of Urology
7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
+81-3-5800-8662
1st name | |
Middle name | |
Last name | Motofumi Suzuki |
The University of Tokyo Hospital
Department of Urology
7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
+81-3-5800-8662
http://www.h.u-tokyo.ac.jp/urology/
SUZUKIM-URO@h.u-tokyo.ac.jp
Department of Urology, The University of Tokyo Hospital
None
Self funding
Kamijyo Clinic, Meirikai Chuo General Hospital, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo Kyosai Hospital, Toshiba Hospital, etc.
NO
東京大学医学部附属病院(東京都)
2010 | Year | 02 | Month | 01 | Day |
Unpublished
Terminated
2009 | Year | 12 | Month | 25 | Day |
2010 | Year | 02 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2010 | Year | 02 | Month | 01 | Day |
2019 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003733
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