Unique ID issued by UMIN | UMIN000021297 |
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Receipt number | R000024426 |
Scientific Title | The Efficacy of Mirabegron on Sleep Quality in Japanese patients with nocturia associated overactive bladder |
Date of disclosure of the study information | 2016/03/02 |
Last modified on | 2018/02/26 17:08:30 |
The Efficacy of Mirabegron on Sleep Quality in Japanese patients with nocturia associated overactive bladder
The Efficacy of Mirabegron on Sleep Quality
The Efficacy of Mirabegron on Sleep Quality in Japanese patients with nocturia associated overactive bladder
The Efficacy of Mirabegron on Sleep Quality
Japan |
Overactive Bladder
Urology |
Others
NO
Analysis of efficacy of mirabegron for sleep disorder in Japanese patients with overactive bladder.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
changes of 12weeks from baseline in OABSS
changes of 12 weeks from baseline in the following items.
bladder diary, Questionnaire(IPSS, N-QOL, PSQI)
parameters measured with Actiwatch
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Mirabegron
12 weeks
50mg
once a day
Not applicable |
Not applicable |
Female
1 Female patients with overactive bladder.(OABSS>2 and Q3>1)
2 Patients whom attending physician has determined to be reasonable for participation.
3 The contents of the questionnaire can be understood without the aid of others.
4 Patients who consent in writing.
(1)Patients who does not consent to this study.
(2) Patients with retention within 12 months.
(3)Patients whose residual urinary volume is more than 100 ml.
(4) Patients with apparent neurogenic bladder.
(5)Patients with bladder disease (bladder cancer, bladder stone, interstitial cystitis etc)
(6)Patients with disease around bladder(endometriosis)
(7)Patients with urinary tract infection, urinary calculus.
(8)Patients with nycturia.
(9)Patients with sleep disorder except the one with nycturia (sleep apnea syndrome, etc).
(10) Patients with mental disorder.
(11) Patients prescribed narcoleptic or medicine for mental disease.
(12)Patients with difficulty in answering the questionnaire without the aid of others.
(13)Patients under treatment with placement of catheter of intermittent self-catheterization.
(14)Patients with circadia rhythm disorder, sift workers, an unsettled lifestyle.
(15)Patients with uncontrollable angle-closure glaucoma
(16)Patient with contraindications to mirabegron(with a history of hypersensitivity to mirabegron, with severe heart disease, on medication with anti-arrhythmics, such as flecainide acetate or propafenone hydrochloride, with long QT syndrome, with difficult-to-control hypertension, with urination difficulty, with severe liver or renal dysfunction)
(17)Patients considered as ineligible for this study by the investigator for other reasons
20
1st name | |
Middle name | |
Last name | Yukihiro Kondo |
Nippon Medical School
Department of Urology
1-1-5 Sendagi, Bunkyo-ku, Tokyo Japan
03-3822-2131
kondoy@nms.ac.jp
1st name | |
Middle name | |
Last name | Yuka Toyama |
Nippon Medical School
Department of Urology
1-1-5 Sendagi, Bunkyo-ku, Tokyo Japan
0338222131
s4036@nms.ac.jp
Nippon Medical School
Astellas Pharma Inc.
Profit organization
NO
2016 | Year | 03 | Month | 02 | Day |
Unpublished
Completed
2015 | Year | 12 | Month | 01 | Day |
2016 | Year | 02 | Month | 01 | Day |
2018 | Year | 01 | Month | 31 | Day |
2016 | Year | 03 | Month | 02 | Day |
2018 | Year | 02 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024426
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