UMIN-CTR Clinical Trial

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
Email	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
Email	torimoto@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042465