UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032304
Receipt number R000036820
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
Date of disclosure of the study information 2018/07/01
Last modified on 2019/10/22 16:25:32

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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 or person

Institute

St.Luke's International University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036820


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name