UMIN-CTR Clinical Trial

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
Email	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
Email	ashikari@med.u-ryukyu.ac.jp

Sponsor
Institute	University of the Ryukyus
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045143