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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042268
Receipt No. R000048259
Scientific Title Studies of change in intra-abdominal pressure using sitting pressure reduction device:fuwatto
Date of disclosure of the study information 2020/11/10
Last modified on 2020/10/28

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Basic information
Public title Studies of change in intra-abdominal pressure using sitting pressure reduction device:fuwatto
Acronym Studies of change in intra-abdominal pressure using sitting pressure reduction device:fuwatto
Scientific Title Studies of change in intra-abdominal pressure using sitting pressure reduction device:fuwatto
Scientific Title:Acronym Studies of change in intra-abdominal pressure using sitting pressure reduction device:fuwatto
Region
Japan

Condition
Condition Urological disorders with dysuria
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is objectively evaluate intra-abdominal pressure with and without sitting pressure reduction device.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urodynamic testing is performed on the target patients, and the bladder and rectal pressures with and without the flutter are measured and evaluated objectively.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Wear a sitting pressure reduction device:fuwatto during urodynamic testing
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing urodynamic testing at our hospital
Key exclusion criteria Patients who do not wish to participate in this study, and
patients who the attending physician has determined to be unable to participate in the study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Noguchi
Organization Saga University of Faculty of Medicine
Division name Department of Urology
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2344
Email nogman@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Maki
Middle name
Last name Kawasaki
Organization Saga University of Faculty of Medicine
Division name Department of Urology
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga
TEL 0952-34-2344
Homepage URL
Email kawasakm@cc.saga-u.ac.jp

Sponsor
Institute Saga University of Faculty of Medicine
Institute
Department

Funding Source
Organization Saga University of Faculty of Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saga University of Faculty of Medicine
Address 5-1-1 Nabeshima, Saga
Tel 0952-34-2344
Email kawasakm@cc.saga-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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 10 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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 10 Day
Last follow-up date
2022 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
2020 Year 10 Month 28 Day
Last modified on
2020 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048259

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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