UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021551 |
|---|---|
| Receipt number | 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 09:23:07 |
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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
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
k.nakane@sapmed.ac.jp
Sponsor or person
Institute
Department of Urology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024847
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
