UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057554 |
|---|---|
| Receipt number | R000065758 |
| Scientific Title | Study on the effectiveness of corrective underwear for pelvic organ prolapse. |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/10/09 07:27:00 |
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Basic information
Public title
Study on the effectiveness of corrective underwear for pelvic organ prolapse.
Acronym
Study on the effectiveness of corrective underwear for pelvic organ prolapse.
Scientific Title
Study on the effectiveness of corrective underwear for pelvic organ prolapse.
Scientific Title:Acronym
Study on the effectiveness of corrective underwear for pelvic organ prolapse.
Region
| Japan |
Condition
Condition
pelvic organ prolapse
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anatomical efficacy of corrective undergarments in patients with pelvic organ prolapse.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of pelvic organ prolapse before and after wearing corrective underwears as assessed by MRI
Key secondary outcomes
Stages of pelvic organ prolapse, quality of life questionnaire score differences, and complications before and after wearing corrective underwears
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI before and after wearing corrective underwear from 1-24 months
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients who are 18 years of age or older at the time of consent
2)Outpatients and inpatients: No questions asked
3)Gender: any gender
4)atients with pelvic organ prolapse
5)Patients who have been fully informed about their participation in this study, and who have given their consent of their own free will based on their full understanding of the study.
Key exclusion criteria
1)Patients ineligible for MRI examination
2)Other patients deemed inappropriate as research subjects by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisanori |
| Middle name | |
| Last name | Taniguchi |
Organization
Kansai Medical University Hospital
Division name
Department of Urology
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata City, Osaka, Japan
TEL
072-804-0101
taniguhi@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hisanori |
| Middle name | |
| Last name | Taniguchi |
Organization
Kansai Medical University Hospital
Division name
Department of Urology
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata City, Osaka, Japan
TEL
072-804-0101
Homepage URL
taniguhi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Hospital
Address
2-3-1 Shinmachi, Hirakata City, Osaka, Japan
Tel
072-804-0101
taniguhi@hirakata.kmu.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
| 2025 | Year | 05 | Month | 01 | 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
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 04 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065758
