UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030107 |
|---|---|
| Receipt number | R000034371 |
| Scientific Title | Exploratory research and effect verification of the posture acting on the pelvic floor muscles |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2019/02/05 10:50:51 |
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Basic information
Public title
Exploratory research and effect verification of the posture acting on the pelvic floor muscles
Acronym
Exploratory of the posture acting on the pelvic floor muscles
Scientific Title
Exploratory research and effect verification of the posture acting on the pelvic floor muscles
Scientific Title:Acronym
Exploratory of the posture acting on the pelvic floor muscles
Region
| Japan |
Condition
Condition
Stress urinary incontinence
Pelvic relaxation
Classification by specialty
| Urology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore and verify methods to strengthen pelvic floor muscles by postures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of bladder neck position using a magnetic resonance
Key secondary outcomes
Success or failure of pelvic floor muscles contraction using ultrasounds
The Japanese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)
Incontinence episodes/ week
1-hour pad test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pelvic floor muscle training by the posture acting on the pelvic floor muscles
Interventions/Control_2
Conventional pelvic floor muscle training
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Women with stress urinary incontinence
Key exclusion criteria
Pregnant
Postpartum women within the last 3 months
Women undergoing treatment for urinary incontinence
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sanae Ninomiya |
Organization
Kyoto University
Division name
Human Hearth Science, Graduate School of Medicine
Zip code
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507
TEL
075-751-3927
ninomiya.sanae.4u@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sanae Ninomiya |
Organization
Kyoto University
Division name
Human Hearth Science, Graduate School of Medicine
Zip code
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507
TEL
075-751-3927
Homepage URL
ninomiya.sanae.4u@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Address
Tel
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
| 2017 | Year | 12 | Month | 25 | 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
| 2017 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 24 | Day |
Last modified on
| 2019 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034371
