UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049546 |
|---|---|
| Receipt number | R000056418 |
| Scientific Title | Efficacy of compression socks for female patients with nocturnal polyuria |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2022/11/17 23:00:28 |
* 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
Efficacy of compression socks for female patients with nocturnal polyuria
Acronym
Efficacy of compression socks for female patients with nocturnal polyuria
Scientific Title
Efficacy of compression socks for female patients with nocturnal polyuria
Scientific Title:Acronym
Efficacy of compression socks for female patients with nocturnal polyuria
Region
| Japan |
Condition
Condition
female nocturia patients with nocturnal polyuria
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of wearing compression stockings for female nocturia patients with nocturnal polyuria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
nocturnal urinary frequency per 24 hours
Key secondary outcomes
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
Wearing a compression socks for 4 weeks
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
Female
Key inclusion criteria
female nocturia patients with nocturnal polyuria
Key exclusion criteria
Patients with hypersensitivity to compression socks material
Patients deemed inappropriate for this study by the principal investigator
Patients who have refused to participate in this study
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | MANAMI |
| Middle name | |
| Last name | KINJO |
Organization
Kyorin University school pf medicine
Division name
Urology
Zip code
1818611
Address
6-20-2 Shinkawa Mitakashi Tokyo
TEL
0422475511
kinjo_1702@yahoo.co.jp
Public contact
Name of contact person
| 1st name | MANAMI |
| Middle name | |
| Last name | KINJO |
Organization
Kyorin University School of Medicine
Division name
Urology
Zip code
1818611
Address
6-20-2 Shinkawa Mitakashi Tokyo
TEL
0422475511
Homepage URL
kinjo_1702@yahoo.co.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Kyorin 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
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa Mitakashi Tokyo
Tel
0422475511
rec@ks.kyorin-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
| 2024 | Year | 03 | Month | 30 | 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
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 12 | 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
| 2022 | Year | 11 | Month | 17 | Day |
Last modified on
| 2022 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056418
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
