UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013433 |
|---|---|
| Receipt number | R000015685 |
| Scientific Title | Clinical investigation of the role of dynamic transrectal ultrasonography on pelvic organ prolapse |
| Date of disclosure of the study information | 2014/03/17 |
| Last modified on | 2014/03/16 17:02:56 |
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Basic information
Public title
Clinical investigation of the role of dynamic transrectal ultrasonography on pelvic organ prolapse
Acronym
Evaluation of dynamic TRUS for POP
Scientific Title
Clinical investigation of the role of dynamic transrectal ultrasonography on pelvic organ prolapse
Scientific Title:Acronym
Evaluation of dynamic TRUS for POP
Region
| Japan |
Condition
Condition
Pelvic organ prlapse
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of transrectal ultrasonography on pelvic organ prolapse
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnosis of POP using transurethral ultrasonography and intraoperative diagnosis
Key secondary outcomes
All of the imaging data during this procedure (hypermobility of bladder neck and urethra, thickness of vaginal wall)
safety assessment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Transrectal ultrasonography
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Symptomatic POP stage >/= 2 according to POP-Q.
2) A patient 1 day before pelvic organ prolapse repair
3) Written informed consent
Key exclusion criteria
1) Inability to give informed consent
2) Pregnancy or desiring future fertility
3) Surgery, transurethral surgery, radiation therapy for pelvic organ malignant disease.
4) surgical management for POP or SUI
5) Judged as being unsuitable for the trial by physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Minagawa |
Organization
Shinshu University Hospital
Division name
Urology
Zip code
Address
Asahi 3-1-1 Matsumoto city, 390-8621, Japan
TEL
0263-37-2661
minagawat@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Minagawa |
Organization
Shinshu University Hospital
Division name
Urology
Zip code
Address
Asahi 3-1-1 Matsumoto city, 390-8621, Japan
TEL
0263-37-2661
Homepage URL
minagawat@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 03 | Month | 17 | 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
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 16 | Day |
Last modified on
| 2014 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015685
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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