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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039078
Receipt No. R000044496
Scientific Title Study of pelvic floor muscle training for volunteers
Date of disclosure of the study information 2020/01/08
Last modified on 2020/01/08

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Basic information
Public title Study of pelvic floor muscle training for volunteers
Acronym Study of pelvic floor muscle training for volunteers
Scientific Title Study of pelvic floor muscle training for volunteers
Scientific Title:Acronym Study of pelvic floor muscle training for volunteers
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study for the add on effect of feedback during contraction of the pelvic floor muscle
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes vaginal squeeze pressure after 3 months training
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 pelvic floor muscle exercises
Interventions/Control_2 pelvic floor muscle exercises with ultrasonography
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria before menopause
null para
Key exclusion criteria severe dysfunction of lower urinary tract function
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takeya
Middle name
Last name Kitta
Organization Hokkaido University Hospital
Division name Department of Renal and Genitourinary surgery
Zip code 060-8648
Address North14 West5,Kitak-ku,Sapporo,Hokkaido,Japan
TEL 011-716-1161
Email kitta@fb3.so-net.ne.jp

Public contact
Name of contact person
1st name Takeya
Middle name
Last name Kitta
Organization Hokkaido University Hospital
Division name Department of Renal and Genitourinary surgery
Zip code 060-8648
Address North14 West5,Kitak-ku,Sapporo,Hokkaido,Japan
TEL 011-716-1161
Homepage URL
Email kitta@fb3.so-net.ne.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Hokkaido University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Hospital Independent clinical research review committee
Address North14 West5,Kitak-ku,Sapporo,Hokkaido,Japan
Tel 011-701-7636
Email crjimu@huhp.hokudai.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
2020 Year 01 Month 08 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
2019 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 20 Day
Last follow-up date
2021 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
2020 Year 01 Month 07 Day
Last modified on
2020 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044496

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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