UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of postpartum pelvic floor muscle training with ultrasound biofeedback on recovery of pelvic floor muscle function: a randomized controlled trial
Title of the study (Brief title)	Effect of postpartum pelvic floor muscle training with ultrasound biofeedback
Region	Japan

Condition
Condition	Pelvic floor muscle dysfunction Urinary stress incontinence Fecal incontinence
Classification by specialty	Obsterics and gynecology Urology Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study aims to evaluate the effectiveness of postpartum pelvic floor muscle training with ultrasound biofeedback for the recovery of pelvic floor muscle function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of pelvic floor muscle function using ultrasounds
Key secondary outcomes	1) Ultrasound evaluation of the success rate in the pelvic floor muscle contraction at each lesson 2) Questionnaires Pelvic floor distress inventory-20(PFDI-20) Fecal incontinence severity index(FISI) International consultation on incontinence questionnaire-short form(ICIQ-SF) Fatigue feelings(Jikakusho shirabe) Fecal incontinence quality of life scale(FIQL) Wexner score Incontinence quality of life(I-QOL) Pelvic floor muscle exercise self-efficacy scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Postpartum pelvic floor muscle training with ultrasound biofeedback
Interventions/Control_2	Postpartum pelvic floor muscle training without ultrasound biofeedback
Interventions/Control_3	Usual care
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	Female
Key inclusion criteria	Primiparous postpartum women
Key exclusion criteria	1) with a history of cesarean section, multiple birth or breech delivery 2) with an experience of incontinence before pregnancy 3) with neuropathic urinary and fecal incontinence 4) with restricted physical activity 5) less than 20 years old
Target sample size	180

Research contact person
Name of lead principal investigator	Megumi Haruna
Organization	The University of Tokyo
Division name	Division of Health Sciences & Nursing, Graduate School of Medicine
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL	03-5841-3396
Email	mharuna-tky@umin.ac.jp

Public contact
Name of contact person	Yurie Asai
Organization	The University of Tokyo
Division name	Division of Health Sciences & Nursing, Graduate School of Medicine
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL	03-5841-3396
Homepage URL
Email	Yurieasai-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 05 Day
Anticipated trial start date	2014 Year 12 Month 08 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	2014 Year 12 Month 08 Day
Last modified on	2016 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018467