Unique ID issued by UMIN | UMIN000007269 |
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Receipt number | R000008576 |
Scientific Title | A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia |
Date of disclosure of the study information | 2012/02/12 |
Last modified on | 2014/02/12 09:31:40 |
A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia
A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia
A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia
A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia
Japan |
Men with overactive bladder induced by benign prostatic hyperplasia
Urology |
Others
NO
To evaluate the efficacy and safety of combination of tamsulosin with mirebegron and tamsulosin monotherapy on patients with overactive bladder induced by benign prostatic hyperplasia
Safety,Efficacy
Exploratory
Not applicable
Change in total score of OABSS at 8 weeks
Changes in total score of IPSS, QOL index and Qmax at 8 weeks
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Central registration
2
Treatment
Medicine |
Harnal (0.2mg daily) for 8weeks
Batanis (50mg daily) and Harnal (0.2mg daily) for 8weeks.
50 | years-old | <= |
Not applicable |
Male
1. Age > or = 50 years-old
2. Patients with benign prostatic hyperplasiua who are treated by tamsulosin at least for 8 weeks
3. OABSS (Q3, urgency score) > or = 2, OABSS (total score) > or = 3
1. Patients with the real child plan
2. Patients suspected malignant disease
3. Patients with urinary retention
4. Ppatients with severe bladder diverticulum
5. Patients with urethral stricture
6. Patients with previous intrapelvic radiation
7. Patients with urinary tract infection, urinary stone, interstitial cystitis
8. Patients with performing clean intermittent catheterization
9. Patients with severe hepatic disorders, severe renal dysfunction and severe cardiovascular diseases
10.Patients who are judged as unsuitable for the trial by doctors.
100
1st name | |
Middle name | |
Last name | Naoya Masumori |
Sapporo Medical University School of Medicine
Department of Urology
S1 W16, Chuo-ku, Sapporo, 060-8543, Japan
1st name | |
Middle name | |
Last name |
Sapporo Medical University School of Medicine
Department of Urology
Department of Urologu, Sapporo Medical University School of Medicine
none
Self funding
NO
2012 | Year | 02 | Month | 12 | Day |
Unpublished
Terminated
2011 | Year | 12 | Month | 19 | Day |
2012 | Year | 01 | Month | 01 | Day |
2014 | Year | 01 | Month | 31 | Day |
2014 | Year | 01 | Month | 31 | Day |
2014 | Year | 01 | Month | 31 | Day |
2012 | Year | 02 | Month | 12 | Day |
2014 | Year | 02 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008576
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