UMIN-CTR Clinical Trial

Basic information
Public title	RCT study on life style measures for nocturia
Acronym	RCT of life style measures for nocturia
Scientific Title	RCT study on life style measures for nocturia
Scientific Title:Acronym	RCT of life style measures for nocturia
Region	Japan

Condition
Condition	nocturia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	comparison oftwo types of life style measures for nocturia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	improvement of nocturnal frequency on frequency volume charts, at 4 weeks after intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	life style measures on, volume of fluid intake, warming at bed-time, moderate exercise, and time of bathing
Interventions/Control_2	life style measures on, amount of salt intake and length of time in bed
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 and Female
Key inclusion criteria	adult patients who void at least once during the night
Key exclusion criteria	1)patients who cannot understand the purpose of treatment 2)patients who cannot perform frequency volume charts 3)patients who have some urologic diseases which cause lower urinary tract symptoms 4)patients who are not appropriate by doctors
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Yoshimura
Organization	Shizuoka General Hospital
Division name	urology
Zip code	420-8527
Address	4-27-1, Kitaando, Aoi-ku, Shizuoka
TEL	054-247-6111
Email	ky7527@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Momoko Middle name Last name Maejima
Organization	Shizuoka General Hospital
Division name	Clinical research control
Zip code	420-8527
Address	4-27-1, Kitaando, Aoi-ku, Shizuoka
TEL	054-247-6111
Homepage URL
Email	chiken-sougou@shizuoka-pho.jp

Sponsor
Institute	Shizuoka General Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical comittee of Shizuoka General Hospital
Address	4-27-1, Kitaando, Aoi-ku, Shizuoka
Tel	054-247-6111
Email	chiken-sougou@shizuoka-pho.jp

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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 01 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	50
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	No longer recruiting
Date of protocol fixation	2015 Year 06 Month 01 Day
Date of IRB	2015 Year 05 Month 26 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2019 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 22 Day
Last modified on	2019 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022502