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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025165
Receipt No. R000028948
Scientific Title A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training for primiparous and multiparous women. (Sango-PFMT Trial)
Date of disclosure of the study information 2016/12/06
Last modified on 2018/06/08

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Basic information
Public title A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training for primiparous and multiparous women. (Sango-PFMT Trial)
Acronym A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training. (Sango-PFMT Trial)
Scientific Title A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training for primiparous and multiparous women. (Sango-PFMT Trial)
Scientific Title:Acronym A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training. (Sango-PFMT Trial)
Region
Japan

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

Objectives
Narrative objectives1 This study aims to evaluate effectiveness of postpartum pelvic floor muscle training with transabdominal ultrasound biofeedback for the recovery of pelvic floor muscle function in primiparous and multiparous women.
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
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Postpartum pelvic floor muscle training with transabdominal ultrasound biofeedback
Interventions/Control_2 Postpartum pelvic floor muscle training without transabdominal ultrasound biofeedback
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 Female
Key inclusion criteria 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 164

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Megumi Haruna
Organization The University of Tokyo
Division name Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
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
1st name
Middle name
Last name Megumi Haruna
Organization The University of Tokyo
Division name Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL 03-5841-3396
Homepage URL
Email mharuna-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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 12 Month 06 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 Completed
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 06 Day
Last follow-up date
2018 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
2016 Year 12 Month 06 Day
Last modified on
2018 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028948

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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