UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042268 |
|---|---|
| Receipt number | 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 | 2021/03/24 16:59:47 |
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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
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
kawasakm@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University of Faculty of Medicine
Institute
Department
Personal name
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
Clinical research center, Saga university hospital
Address
5-1-1 Nabeshima, Saga
Tel
0952-34-3400
kenkyu-shinsei@ml.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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
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
| 2021 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048259
