UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039078 |
|---|---|
| Receipt number | R000044496 |
| Scientific Title | Study of pelvic floor muscle training for volunteers |
| Date of disclosure of the study information | 2020/01/08 |
| Last modified on | 2021/02/02 09:55:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kitta@fb3.so-net.ne.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 09 | Day |
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
| 2021 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044496
