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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021551
Receipt No. R000024847
Scientific Title Cognitive behavioral therapy using self-check sheet for nocturia
Date of disclosure of the study information 2016/05/01
Last modified on 2019/09/22

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Basic information
Public title Cognitive behavioral therapy using self-check sheet for nocturia
Acronym Cognitive behavioral therapy for nocturia
Scientific Title Cognitive behavioral therapy using self-check sheet for nocturia
Scientific Title:Acronym Cognitive behavioral therapy for nocturia
Region
Japan

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

Objectives
Narrative objectives1 To search the efficacy of cognitive behavioral therapy using self-check sheet for nocturia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in the number of episodes of nocturia after 4 weeks
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Interventions: Cognitive behavioral therapy using self-check sheet in daily 4 weeks.
Interventions/Control_2 Controls: No therapy
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the new outpatient whose chief complaint is nocturia and who voids 2 times or more a night.
Key exclusion criteria 1. the patient whose residual urine volume is 200 ml or more.
2. the patient who received medication for lower urinary tract symptom within before 3 months.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Masumori
Organization Sapporo Medical University School of Medicine
Division name Department of Urology
Zip code 060-8543
Address S-1, W-16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Email masumori@sapmed.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Nakane
Organization Sapporo Medical University School of Medicine
Division name Department of clinical reseach
Zip code 060-8543
Address S-1, W-16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Homepage URL
Email k.nakane@sapmed.ac.jp

Sponsor
Institute Department of Urology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Department of Urology, Sapporo Medical University School of Medicine
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 Sapporo Medical University School of Medicine
Address S-1, W-16, Chuo-ku, Sapporo, Japan
Tel 011-611-2111
Email k.nakane@sapmed.ac.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
2016 Year 05 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
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 Completed
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
2016 Year 04 Month 20 Day
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 20 Day
Last modified on
2019 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024847

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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