UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049226 |
|---|---|
| Receipt number | R000056065 |
| Scientific Title | Verification of the effect of electrical stimulation on pelvic floor muscles |
| Date of disclosure of the study information | 2022/10/15 |
| Last modified on | 2024/04/16 19:45:02 |
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Basic information
Public title
Verification of the effect of electrical stimulation on pelvic floor muscles
Acronym
Verification of the effect of electrical stimulation on pelvic floor muscles
Scientific Title
Verification of the effect of electrical stimulation on pelvic floor muscles
Scientific Title:Acronym
Verification of the effect of electrical stimulation on pelvic floor muscles
Region
| Japan |
Condition
Condition
Women with urinary incontinence symptoms
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of electrical stimulation on pelvic floor muscle function and symptom improvement in women with urinary incontinence symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pelvic floor muscle function
Key secondary outcomes
Number of urinary incontinence,
Number of urination,
Subjective symptoms,
Quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A combined program of standard pelvic floor muscle training and electrical stimulation at least three times per week.
Interventions/Control_2
Standard pelvic floor muscle training at least 3 times per week.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women over 30 years old with urinary
incontinence symptoms
Key exclusion criteria
Patients undergoing treatment for urological or gynecological disorders
Patients with some reason that precludes the implementation of electrical stimulation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tamaki |
Organization
Hyogo Medical University
Division name
School of Rehabilitation
Zip code
605-8530
Address
1-3-6, Minatojima, Chuo-ku, Kobe city, Hyogo
TEL
81-78-304-3049
a-tamaki@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tamaki |
Organization
Hyogo Medical University
Division name
School of Rehabilitation
Zip code
650-8530
Address
1-3-6, Minatojima, Chuo-ku, Kobe city, Hyogo
TEL
81-78-304-3049
Homepage URL
a-tamaki@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
homerion cooporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-3-6, Minatojima, Chuo-ku, Kobe city, Hyogo
Tel
81-78-304-3000
a-tamaki@hyo-med.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
| 2022 | Year | 10 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 10 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056065
| Research Plan | |
|---|---|
| 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 |
