UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047932 |
|---|---|
| Receipt number | R000054641 |
| Scientific Title | Effects of Pelvic Floor Muscle Training in Preventing Urinary Incontinence |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2024/02/21 16:42:49 |
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Basic information
Public title
Effects of Pelvic Floor Muscle Training in Preventing Urinary Incontinence
Acronym
Effects of Pelvic Floor Muscle Training in Preventing Urinary Incontinence
Scientific Title
Effects of Pelvic Floor Muscle Training in Preventing Urinary Incontinence
Scientific Title:Acronym
Effects of Pelvic Floor Muscle Training in Preventing Urinary Incontinence
Region
| Japan |
Condition
Condition
urinary incontinence
Classification by specialty
| Rehabilitation medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to analyze and present numerical data on the effectiveness of hip lift exercises in improving urine leakage and the contractility of pelvic floor muscle groups in women with urine leakage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pelvic floor elevation by transabdominal ultrasound
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
1)Hip Lift Exercises group
Interventions/Control_2
2)Leg Raise Exercises group
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Women with urinary incontinence
Key exclusion criteria
Orthopedic diseases of the lower back and pelvic girdle area
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyo |
| Middle name | |
| Last name | Kamio |
Organization
Tokyo Metropolitan University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
116-8551
Address
7-2-10 Higashiogu Arakawaku Tokyo, JAPAN
TEL
03-3819-1211
horikawa@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyo |
| Middle name | |
| Last name | Kamio |
Organization
Tokyo Metropolitan University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
116-8551
Address
7-2-10 Higashiogu Arakawaku Tokyo, JAPAN
TEL
03-3819-1211
Homepage URL
horikawa@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Venus Japan
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
Research Ethics Committee, Tokyo Metropolitan University Arakawa Campus
Address
7-2-10 Higashiogu Arakawaku Tokyo, JAPAN
Tel
03-3819-1211
rinri-hs@tmu.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 | 06 | Month | 30 | 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
29
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
| 2022 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 07 | 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 | 06 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054641
| 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 |
