UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019456 |
|---|---|
| Receipt number | R000022502 |
| Scientific Title | RCT study on life style measures for nocturia |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2019/10/25 17:39:17 |
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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
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
chiken-sougou@shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022502
