UMIN-CTR Clinical Trial

Basic information
Public title	Good combination therapy with alpha-blocker plus imidafenacin or mirabegron for nocturia in overactive bladder with benign prostatic hyperplasia; prospective randomized trial
Acronym	Good-Night study 2
Scientific Title	Good combination therapy with alpha-blocker plus imidafenacin or mirabegron for nocturia in overactive bladder with benign prostatic hyperplasia; prospective randomized trial
Scientific Title:Acronym	Good-Night study 2
Region	Japan

Condition
Condition	Overactive Bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of imidafenacin or mirabegron after failed treatment by alpha1 blocker in male OAB/BPH patients with nocturia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Mean frequency of nocturnal mictrition
Key secondary outcomes	1) N-QOL 2) OABSS 3) IPSS&QOL 4) mean night-time urine volume 5) voided volume 6) residual urine volume 7) adverse events and side-effects

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Any alpha-blocker plus imidafenacin 0.2mg/day bid.
Interventions/Control_2	Any alpha-blocker plus mirabegron 50mg/day qd after meal
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Patients with 1) alpha-blocker treatment over 4 weeks 2) urinary urgency more than once a week (Question 3 of OABSS >=2) 3) nocturia more than twice a day on average in bladder diary 4) more than 20 years old
Key exclusion criteria	1) Urinary retention within a year 2) Residual urine >=50mL 3) Strong 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, circadian rhythm disorder, and irregular lifestyle 8) Bladder training conducted over the past 10 days 9) Active acute urinary tract infection 10) Hormones or 5 alpha-reductase inhibitor started to have within the past six months 11) Contraindication to imidafenacin (primary angle-closure glaucoma, urinary retention, obstructive intestinal disease, paralytic ileus, gastrointestinal atony, myastania gravis) 12) Contraindication to mirabegron (severe heart disease, severe liver dysfunction, treatment of flecainide or propaphenone) 13) Untreated severe hypertension (more than Class II in JSH 2009, SBP>=160mmHg or DBP>= 100mmHg) 14) Judged as being unsuitable for the trial by physician.
Target sample size	300

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Osamu Yokoyama
Organization	Faculty of Medical Science, University of Fukui
Division name	Urology
Zip code
Address	23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui
TEL	0776-61-8396
Email	oyoko@u-fukui.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Yasushi Miyagawa
Organization	Osaka-Hokuriku male LUTS Conference Secretariat(Osaka University Hospital)
Division name	Urology
Zip code
Address	Yamadaoka 2-2, Suita, Osaka 565-0871
TEL	06-6879-3531
Homepage URL
Email	miyagawa@uro.med.osaka-u.ac.jp

Sponsor
Institute	Osaka-Hokuriku maleLUTS Conference
Institute
Department

Funding Source
Organization	The Supporting Center of the Clinical Research and Education
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪医科大学附属病院（大阪府）、大阪市立大学医学部附属病院（大阪府）、大阪大学医学部附属病院（大阪府）、金沢大学附属病院（石川県）、関西医科大学附属枚方病院（大阪府）、関西医科大学附属滝井病院（大阪府）、近畿大学医学部附属病院（大阪府）、富山大学附属病院（富山県）、福井大学附属病院（福井県）以上8大学の泌尿器科およびその関連施設

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2015 Year 08 Month 31 Day
Date of closure to data entry	2015 Year 09 Month 30 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 03 Month 27 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012088