UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051659 |
|---|---|
| Receipt number | R000058744 |
| Scientific Title | Feasibility study of bladder training app and urination prediction device for women having symptoms of urinary urgency or urine leakage |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2024/03/14 10:05:37 |
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Basic information
Public title
Feasibility study of bladder training app and urination prediction device for women having symptoms of urinary urgency or urine leakage
Acronym
Feasibility study of bladder training app and urination prediction device for women having symptoms of urinary urgency or urine leakage
Scientific Title
Feasibility study of bladder training app and urination prediction device for women having symptoms of urinary urgency or urine leakage
Scientific Title:Acronym
Feasibility study of bladder training app and urination prediction device for women having symptoms of urinary urgency or urine leakage
Region
| Japan |
Condition
Condition
urinary incontinence, Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of bladder training app and urination prediction device for women having symptoms of urinary urgency or urine leakage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline (observation period) in average daily frequency of urination at 8 weeks of treatment period
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
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
bladder training app and urination prediction device
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1)Women between the ages of 20 and 64 at the time consent is obtained
2)Participants whose urinary frequency averaged between 8 and 14 times per 24 hours in the urinary status recorded on the app during the observation period
3)Participants who had urinary urgency or leakage with urinary urgency at least once per 24 hours in the urinary status recorded on the app during the observation period.
4)Participants who can attach DFree and perform bladder training for a certain period
5)Participants who can use online conferencing tools and LINE
6)Participants who have an iPhone supported by iOS13 or higher (iPhone 6s or higher)
Key exclusion criteria
1)Participants who have hematuria
2)Participants who have discomfort or pain associated with urination
3)Participants who have a residual urine
4)Participants who are taking medication for overactive bladder
5)Participants with a history of pelvic surgery or radiation therapy
6)Participants with a history of neurological disease
7)Participants who are using estrogen preparations
8)Participants with the following diseases (diabetes, spina bifida, uterine fibroids, severe constipation, peripheral neuropathy)
9)Pregnant participants
10)Participants who are using implantable medical devices (pacemakers, defibrillators, etc.)
11)Participants whose records of DFree did not reach zero after urinating during the observation period
12)Participants who are considered as inappropriate for this study by the research collaborating physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Nozoe |
Organization
Save Medical Corporation
Division name
Business Development Department
Zip code
103-0023
Address
Wakamatsu building 2F, 3-3-6, Nihonbashihonmachi, Chuo-ku, Tokyo, Japan
TEL
050-3612-4524
bd@savemedical.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Tamura |
Organization
Save Medical Corporation
Division name
Business Development Department
Zip code
103-0023
Address
Wakamatsu building 2F, 3-3-6, Nihonbashihonmachi, Chuo-ku, Tokyo, Japan
TEL
050-3612-4524
Homepage URL
bd@savemedical.jp
Sponsor or person
Institute
Save Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of Health Preventive Medicine Foundation
Address
1-25-1, Asahicho, Atsugi Shi, Kanagawa , 243-0014, Japan
Tel
046-227-2005
kanri@hpm.or.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
| 2023 | Year | 07 | Month | 20 | 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
10
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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058744
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
