UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of instructional methods by digital vaginal palpation and transabdominal ultrasound in pelvic floor muscle training after vaginal delivery: A randomized controlled trial
Acronym	PFMT by digital vaginal palpation and transabdominal ultrasound
Scientific Title	Comparison of instructional methods by digital vaginal palpation and transabdominal ultrasound in pelvic floor muscle training after vaginal delivery: A randomized controlled trial
Scientific Title:Acronym	PFMT by digital vaginal palpation and transabdominal ultrasound
Region	Japan

Condition
Condition	Women after vaginal delivery
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of digital vaginal palpation and transabdominal ultrasound in pelvic floor muscle training instruction method for low-risk women after vaginal delivery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bladder base movement during voluntary pelvic floor muscle contraction by Transabdominal ultrasound
Key secondary outcomes	1. Fast repetition 2. Endurance 3. Understanding the contraction muscle/Contraction feeling 4. Confidence for pelvic floor muscle training 5. Motivation for pelvic floor muscle training

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Pelvic floor muscle training by digital vaginal palpation
Interventions/Control_2	Pelvic floor muscle training by transabdominal ultrasound
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	Women 4-6weeks after vaginal delivery of 37 or more weeks
Key exclusion criteria	1.Experience of pelvic floor muscle training using digital vaginal palpation or transabdominal ultrasound 2.Abnormality in postpartum process 3.Pain and numbness of the perineum 4.Neuropathic urinary incontinence 5.Age under 20 years old 6.Unable read or write in Japanese
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Akiko Middle name Last name Mori
Organization	St. Luke's International University
Division name	College of Nursing
Zip code	104-0044
Address	10-1,Akashi-cho,Chuo-ku,Tokyo, Japan
TEL	03-3543-6391
Email	akiko-mori@slcn.ac.jp

Public contact
Name of contact person	1st name Mayumi Middle name Last name Ikeda
Organization	St.Luke's International University Graduate school
Division name	Doctoral student
Zip code	104-0044
Address	10-1,Akashi-cho,Chuo-ku,Tokyo, Japan
TEL	03-3543-6391
Homepage URL
Email	16DN003@slcn.ac.jp

Sponsor
Institute	St.Luke's International University
Institute
Department

Funding Source
Organization	Japan Health Academy
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	St.Luke's International University
Address	10-1,Akashi-cho,Chuo-ku,Tokyo,Japan
Tel	03-3543-6391
Email	kenkyukikaku@luke.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	2018 Year 07 Month 01 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	2018 Year 04 Month 12 Day
Date of IRB	2018 Year 06 Month 14 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 18 Day
Last modified on	2019 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036820