UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039858 |
|---|---|
| Receipt number | R000045076 |
| Scientific Title | Research and development of innovative method to diagnose pelvic floor dysfunction |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2021/03/21 15:15:18 |
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Basic information
Public title
Research and development of innovative method to diagnose pelvic floor dysfunction
Acronym
Research and development of innovative method to diagnose pelvic floor dysfunction
Scientific Title
Research and development of innovative method to diagnose pelvic floor dysfunction
Scientific Title:Acronym
Research and development of innovative method to diagnose pelvic floor dysfunction
Region
| Japan |
Condition
Condition
Pelvic floor dysfunction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a new diagnostic technique for accurate diagnosis of pelvic floor dysfunction, the shape of the vaginal cavity and the compliance of vagina is investigated and analyzed in patients with pelvic organ prolapse and normal patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intravaginal pressure and volume
Key secondary outcomes
Shape of vagina
Tissue compliance measured by elastgraphy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The vaginal cavity is ultrasonically constructed to measure vaginal wall compliance, by using intravaginal balloon dilation.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients who visited a gynecological outpatient clinic.
2) Patients whose performance Status is 0-1 can be examined at the obstetrics and gynecology examination table.
3) The consent has been obtained from the person in writing.
Key exclusion criteria
1) Patients whose vaginal cavity is too small to allow internal examination and transvaginal ultrasonography.
2) Patients who cannot undergo internal examination and transvaginal ultrasonography due to pain.
3) Patients with infections in gynecological organs
4) Other patients who are judged by the investigator or participating physician to be ineligible for this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Kimura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
565-0871
Address
2-2 Yamadaoka Suita
TEL
0668793351
tadashi@gyne.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Kodama |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
565-0871
Address
2-2 Yamadaoka Suita
TEL
0668793351
Homepage URL
mkodama@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
2-2 Yamadaoka Zuita
Tel
0662108296
rinri@hp-crc.med.osaka-u.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 | 03 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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 | 03 | Month | 18 | Day |
Last modified on
| 2021 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045076
