UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of compression stockings for nocturia
Acronym	Usefulness of compression stockings for nocturia
Scientific Title	Usefulness of compression stockings for nocturia
Scientific Title:Acronym	Usefulness of compression stockings for nocturia
Region	Japan

Condition
Condition	Nocturia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the usefulness of wearing compression stockings for nocturia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of change in nocturnal urination frequency in frequency volume chart
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Compression stockings worn nightly for 1 month
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with nocturia
Key exclusion criteria	Patients with hypersensitivity to compression stocking 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 Tomonori Middle name Last name Yamanishi
Organization	Dokkyo Medical University Hospital
Division name	Continence Center, Department of Urology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL	0282-86-1111
Email	yamanish@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Kanya Middle name Last name Kaga
Organization	Dokkyo Medical University Hospital
Division name	Continence Center, Department of Urology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL	0282-86-1111
Homepage URL
Email	k-kaga@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University Hospital
Institute
Department

Funding Source
Organization	SOLVE
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	Ethics Review Committee, Dokkyo Medical University Hospital
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel	0282-86-1111
Email	syomuka@dokkyomed.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	2022 Year 03 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	34
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	2020 Year 10 Month 30 Day
Date of IRB	2021 Year 01 Month 15 Day
Anticipated trial start date	2021 Year 01 Month 16 Day
Last follow-up date	2022 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 03 Month 17 Day
Last modified on	2022 Year 03 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053832