UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Individual intervention of the pelvic floor muscle training used the biofeedback therapy for potentially stress urinary incontinence in female.
Title of the study (Brief title)	Individual intervention of the pelvic floor muscle training used the biofeedback therapy for potentially stress urinary incontinence in female.
Region	Japan

Condition
Condition	stress urinary incontinence
Classification by specialty	Obsterics and gynecology Urology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Individual intervention of the pelvic floor muscle training used the biofeedback therapy for potentially stress urinary incontinence
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Maximum force of contraction pelvic floor muscle measured values
Key secondary outcomes

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Oral presentation
Interventions/Control_2	pelvic floor muscle measurements Individual intervention of the pelvic floor muscle training used the biofeedback therapy
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	30 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	Delivery history Female
Key exclusion criteria	Pregnant and parturient women treated with urinary incontinence stress urinary incontinence other than. menstruation ever receive guidance for PMFT Pelvic visceral disease Cranial nerve Disease
Target sample size	60

Research contact person
Name of lead principal investigator	Youko Omori
Organization	Shiga University of Medical Science
Division name	Clinical Nursing
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	077-548-2111
Email	yoomori@belle.shiga-med.ac.jp

Public contact
Name of contact person	Youko omori
Organization	Shiga University of Medical Science,Graduate school
Division name	Clinical Nursing
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL	077-522-4607
Homepage URL
Email	yoomori@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	大津市民病院（滋賀県、大津市）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 22 Day
Last follow-up date	2016 Year 03 Month 31 Day
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	2014 Year 09 Month 12 Day
Last modified on	2016 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017527