UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041909 |
|---|---|
| Receipt number | R000045143 |
| Scientific Title | The intervention study of elastic compression stockings on nocturia induced by leg edema |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2022/03/31 19:12:26 |
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Basic information
Public title
The effect of elastic compression stockings on nocturia induced by leg edema
Acronym
The effect of elastic compression stockings on nocturia
Scientific Title
The intervention study of elastic compression stockings on nocturia induced by leg edema
Scientific Title:Acronym
The intervention study of elastic compression stockings on nocturia
Region
| Japan |
Condition
Condition
noctuira
Classification by specialty
| Medicine in general | Geriatrics | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to confirm that nocturia with leg edema is improved by putting on elastic compression stockings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary frequency a at night after putting on elastic compression stockings for 4 weeks
Key secondary outcomes
voided volume, nocturnal polyuria index, IPSS, OABSS, patient satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
putting on elastic compression stocking for 4 weeks
Interventions/Control_2
without elastic compression stocking for 4 weeks
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
Male and Female
Key inclusion criteria
1. Urinary frequency at night 1 or more time
2. Patients with pitting leg edema
3. Patients who can understand this study and consent in writing based on his free will
Key exclusion criteria
1. Patients with heart falure symptom,
or BNP>100 pg/ml, NTproBNP>400 pg/ml, or EF<50%
2. Patients with diabetes insioidus
3. Patients with past history of hypersensitivity to elastic compression stocking
4. Patients who cannot answer to questionaire by myself
5. Patients who were judged inadequate for this study by the doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Ashikari |
Organization
University of the Ryukyus
Division name
Department of Urology, Graduate School of Medicine
Zip code
9030215
Address
207 Uehara, Nishihara, Okinawa
TEL
0988951186
ashikari@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Ashikari |
Organization
University of the Ryukyus
Division name
Department of Urology, Graduate School of Medicine
Zip code
9030215
Address
207 Uehara, Nishihara, Okinawa
TEL
0988951186
Homepage URL
https://ryukyu-urology.jp/patient.php
ashikari@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus
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
Ethics Comittee of University of the Ryukyus for Medical and Health Research Involving Human Subjects
Address
207 Uehara, Nishihara, Okinawa
Tel
0988951543
krinken@acs.u-ryukyu.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 | 09 | Month | 28 | 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 | 09 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2023 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045143
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
