UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037272 |
|---|---|
| Receipt number | R000042465 |
| Scientific Title | The study for demonstrating that the ability of the bladder to absorb urine and adjust its volume during bedtime contributes to the maintenance of sleep |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2021/01/10 16:10:52 |
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Basic information
Public title
Assessment of bladder function for stabilizing urinary volume overnight with recording of brain waves
Acronym
the ABSORB study
Scientific Title
The study for demonstrating that the ability of the bladder to absorb urine and adjust its volume during bedtime contributes to the maintenance of sleep
Scientific Title:Acronym
the ABSORB study
Region
| Japan |
Condition
Condition
Nocturia
Classification by specialty
| Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate that the bladder absorbs urine during bedtime to adjust the inside urinary volume and contributes to the maintenance of sleep
Basic objectives2
Others
Basic objectives -Others
Physiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Temporal change of estimated bladder volume based on urinary indigocarmine concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
- Indwelling of Foley catheter
- Setting of a portable electroencephalograph
- Injection of indigocarmine solution 20 mL into the bladder
- Period: a night
Interventions/Control_2
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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
No urination during bedtime
Key exclusion criteria
Awakening by urination during bedtime
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Torimoto |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
torimoto@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Torimoto |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
torimoto@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Research Ethics Committee of Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara, 634-8522 Japan
Tel
0744-22-3051
f-okumura@naramed-u.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
奈良県立医科大学（奈良県）/Nara Medical University (Kashihara, Nara, Japan)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
11
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
Main results already published
Date of protocol fixation
| 2019 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 04 | Day |
Last modified on
| 2021 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042465
