UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Determine of effectiveness of the pelvic floor support underwear in female stress urinary incontinence
Title of the study (Brief title)	Determine of effectiveness of the pelvic floor support underwear in female stress urinary incontinence
Region	Japan

Condition
Condition	Stress urinary incontinence
Classification by specialty	Urology Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine of effectiveness of the pelvic floor support underwear in female stress urinary incontinence
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptoms of urinary incontinence 1)The 1-hour pad test 2)Incontinence episodes per week 3)The Japanese version of International Consultation on Incontinence Questionnaire Short Form(ICIQ-SF)
Key secondary outcomes	1)The frequency of voiding per day 2)Number of days to wear the underwear 3)Subjective change of urinary incontinence

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Wearing the pelvic floor support underwear for 12-weeks
Interventions/Control_2	Wearing the pelvic floor support underwear and pads for 12-weeks
Interventions/Control_3	Wearing the pads for 12-weeks
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	30 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	Women with stress urinary incontinence
Key exclusion criteria	Pregnant Postpartum women within the last 3 months Women undergoing treatment for urinary incontinence
Target sample size	105

Research contact person
Name of lead principal investigator	Hisayo Okayama
Organization	University of Tsukuba
Division name	Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575
TEL	029-853-8372
Email	okayama@md.tsukuba.ac.jp

Public contact
Name of contact person	Sanae Ninomiya
Organization	Kyoto University
Division name	Human Hearth Science, Graduate School of Medicine
Address	53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507
TEL	075-751-3927
Homepage URL
Email	ninomiya.sanae.4u@kyoto-u.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Wacoal holdings corp. Japan
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto university
Name of secondary funｄer(s)

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	2018 Year 01 Month 31 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 12 Month 05 Day
Anticipated trial start date	2017 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 04 Day
Last modified on	2019 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034558