UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058694 |
|---|---|
| Receipt number | R000067110 |
| Scientific Title | An intervention study on the effectiveness of pelvic floor yoga for pelvic organ prolapse in middle-aged and elderly women |
| Date of disclosure of the study information | 2025/08/05 |
| Last modified on | 2025/08/04 20:41:33 |
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Basic information
Public title
Verification of pelvic floor yoga to improve pelvic organ prolapse symptoms and mental health in middle-aged and elderly women
Acronym
Intervention trial using pelvic floor muscle yoga
Scientific Title
An intervention study on the effectiveness of pelvic floor yoga for pelvic organ prolapse in middle-aged and elderly women
Scientific Title:Acronym
Intervention trial using pelvic floor muscle yoga
Region
| Japan |
Condition
Condition
pelvic organs prolapse
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether pelvic floor yoga can improve pelvic organ prolapse symptoms and mental health in middle-aged and elderly women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
POP-Q score (measured by doctor's internal examination)
Key secondary outcomes
Changes in muscle strength of knee extensors, hip adductors and external rotators
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
pelvic floor muscle yoga
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
| 45 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
A middle-aged and elderly woman who visited a pelvic organ prolapse outpatient clinic and was diagnosed with pelvic organ prolapse stages I to II and received permission from her doctor to participate in yoga
Key exclusion criteria
Pelvic organs prolapse stage III or higher
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | NAOKO |
| Middle name | |
| Last name | INOUE |
Organization
Tokyo Medical and Health Association Nerima General Hospital
Division name
nursing department
Zip code
176-8530
Address
1-24-1 Asahigaoka, Nerima-ku, Tokyo
TEL
03-5988-2200
info@nerima-hosp.or.jp
Public contact
Name of contact person
| 1st name | NAOKO |
| Middle name | |
| Last name | INOUE |
Organization
Tokyo Medical and Health Association Nerima General Hospital
Division name
nursing department
Zip code
176-8530
Address
1-24-1 Asahigaoka, Nerima-ku, Tokyo
TEL
03-5988-2200
Homepage URL
info@nerima-hosp.or.jp
Sponsor or person
Institute
Tokyo Medical and Health Association Nerima General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Health Association Nerima General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Health Association Nerima General Hospital
Address
1-24-1 Asahigaoka, Nerima-ku, Tokyo
Tel
03-5988-2200
info@nerima-hosp.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
公益財団法人 東京都医療保健協会 練馬総合病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067110
