UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057712 |
|---|---|
| Receipt number | R000065944 |
| Scientific Title | Effectiveness of Pelvic Floor Muscle Training in Improving Urinary Incontinence |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/04/24 16:35:54 |
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Basic information
Public title
Effectiveness of Pelvic Floor Muscle Training in Improving Urinary Incontinence
Acronym
Pelvic Floor Intervention Training
Scientific Title
Effectiveness of Pelvic Floor Muscle Training in Improving Urinary Incontinence
Scientific Title:Acronym
Effectiveness of Pelvic Floor Muscle Training in Improving Urinary Incontinence: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Stress Urinary Incontinence
Classification by specialty
| Urology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore whether the urinary incontinence improvement training offered at a women-only fitness club is a simple and sustainable intervention for middle-aged and older women with stress urinary incontinence who have not sought medical care. Additionally, the study aims to investigate the potential effectiveness of this training in improving urinary incontinence symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pelvic floor elevation measured by ultrasound imaging
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
hip lift
Interventions/Control_2
hip lift with ball squeeze
Interventions/Control_3
Kneeling gluteal contraction with ball squeeze
Interventions/Control_4
hip lift with resistance band
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Women who experience stress urinary incontinence at least once a week
Key exclusion criteria
Presence of voiding dysfunction due to neurological disorders
Presence of orthopedic disorders in the lumbar spine or pelvic region
History of gynecological diseases or surgeries
Currently receiving medical treatment for urinary incontinence
Currently pregnant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroyo |
| Middle name | |
| Last name | Kamio |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
168551
Address
7-2-10 Higashiogu Arakawaku Tokyo
TEL
0338191211
horikawa@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyo |
| Middle name | |
| Last name | Kamio |
Organization
Tokyo metropolitan Univesity
Division name
Graduate School of Human Health Sciences
Zip code
1168551
Address
7-2-10 Higashiogu Arakawaku Tokyo
TEL
338191211
Homepage URL
horikawa@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Univesity
Institute
Department
Personal name
Hiroyo Kamio
Funding Source
Organization
Venus Japan Co., Ltd.
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
Tokyo metropolitan University
Address
7-2-10 Higashiogu Arakawaku Tokyo
Tel
0338191211
horikawa@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
| 2025 | 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
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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 04 | Month | 24 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065944
