Unique ID issued by UMIN | UMIN000002344 |
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Receipt number | R000002874 |
Scientific Title | Good combination therapy, alpha-blocker and imidafenacin, for Nocturia of Benign Prostatic Hyperplasia with OAB in Osaka-Hokuriku study group. |
Date of disclosure of the study information | 2009/08/17 |
Last modified on | 2014/09/29 20:20:57 |
Good combination therapy, alpha-blocker and imidafenacin, for Nocturia of Benign Prostatic Hyperplasia with OAB in Osaka-Hokuriku study group.
Good-Night study
Good combination therapy, alpha-blocker and imidafenacin, for Nocturia of Benign Prostatic Hyperplasia with OAB in Osaka-Hokuriku study group.
Good-Night study
Japan |
Overactive Bladder
Urology |
Others
NO
Combination therapy with alpha-1 blocker and imidafenacin in Benign Prostatic Hyperplasia with OAB: Effects on Nocturia and nocturnal sleep and safety
Safety,Efficacy
Pragmatic
Not applicable
1) Mean freaquency of nocturnal mictrition,
2) N-QOL,
3) Pittsburgh Sleep Quality Index)
1) OABSS
2) IPSS&QOL
3) mean night-time urine
(mean nocturnal urine volume)
4) maximum voided volume
5) residual urine volume
6) adverse events and side-effects
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is not considered as adjustment factor.
YES
Central registration
3
Treatment
Medicine |
continuous oral administration of alpha-blocker (be available to any medicine)
Any alpha-blocker plus imidafenacin 0.2mg/day bid.
Any alpha-blocker plus imidafenacin 0.1mg/day administration before sleep
Not applicable |
Not applicable |
Male
Patients has urinary urgency once a week or more and also has nocturia (Question 2 of OABSS>=2 and Question 7 of IPSS>=2) after alpha-blocker treatment over the past 1 month or longer.
(be available to all ages)
1) Urinary retention within a year
2) Residual urine >=50mL
3) Suspect of prostate cancer
4) Treatment of any anti-muscarinic agent or beta-stimulants within a month.
5) Indwelling catheter or self intermittent urinary catherization
6) Diseases that affect nocturia (sleep apnea syndrome, Restless legs syndrome, insomnia etc.)
7) The shift work and circadian rhythm disorder, patients with irregular lifestyle
8) Bladder training conducted over the past 10 days
9) Active urinary tract infection
10) Having been given hormones or 5 alpha-reductase inhibitor within the past six months
11) Contraindication to Imidafenacin (Primary angle-closure glaucoma, urinary retention, Obstructive intestinal disease, paralytic ileus, gastrointerstinal atony, myastania gravis)
12) Judged as being unsuitable for the trial by the researcher.
300
1st name | |
Middle name | |
Last name | Osamu Yokoyama |
Faculty of Medical Science, University of Fukui
Urology
23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui
0776-61-3111
oyoko@u-fukui.ac.jp
1st name | |
Middle name | |
Last name | Yasushi Miyagawa |
Osaka-Hokuriku maleLUTS Conference Secretariat(Osaka University Hospital)
Urology
Yamadaoka 2-2, Suita, Osaka 565-0871
06-6879-3531
miyagawa@uro.med.osaka-u.ac.jp
Osaka-Hokuriku maleLUTS Conference Secretariat
None
Self funding
None
Osaka Medical College
Osaka City Univ.
Osaka Univ.
Kanazawa Medical Univ.
Kanazawa Univ.
Kansai Medical Univ.
Kinki Univ.
University of Toyama
University of Fukui
and the related facilities
NO
2009 | Year | 08 | Month | 17 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/25224929
Add-on anticholinaergic therapy for residual nocturia in patients with lower urinary tract symptoms receiving alpha 1- blocker treatmen: a multi-centre, prospective, randomised study.
A short half-life anticholinergic is suggested to be safe and effective as an add-on therapy for residual nocturia in patients with male LUTS receiving alpha 1-blocker treatment. Anticholinergic admiistration nightly could reduce the nocturnal urine volume.
Completed
2009 | Year | 05 | Month | 01 | Day |
2009 | Year | 05 | Month | 01 | Day |
2011 | Year | 07 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2009 | Year | 08 | Month | 17 | Day |
2014 | Year | 09 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002874
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