UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045052
Receipt number R000051465
Scientific Title Effects of Pelvic Floor Muscle Training by remote guidance
Date of disclosure of the study information 2021/08/03
Last modified on 2023/01/24 08:44:45

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Basic information

Public title

Effects of Pelvic Floor Muscle Training by remote guidance

Acronym

Effects of Pelvic Floor Muscle Training by remote guidance

Scientific Title

Effects of Pelvic Floor Muscle Training by remote guidance

Scientific Title:Acronym

Effects of Pelvic Floor Muscle Training by remote guidance

Region

Japan


Condition

Condition

Urinary incontinence

Classification by specialty

Obstetrics and Gynecology Urology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the effect of Pelvic Floor Muscle Training by remote guidance in middle and aged women.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

International Consultation on Incontinence Questionnaire-short form at 0,2,4,6,12 weeks

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Remote guidance three times and Pelvic floor muscle training for 12 weeks

Interventions/Control_2


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

45 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Healthy women of 45 years old and over that agreed to participate in this study.

Key exclusion criteria

Currently being treatment of gynecologic disease and urinary incontinence, suffering from urologic infectious disease, pelvic fracture for the last 3 months, disable to understand explanations and continue participate in this study

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Akiko
Middle name
Last name Mori

Organization

Hyogo University of Health Sciences

Division name

Department of Physical Therapy, School of Rehabilitation

Zip code

6508530

Address

1-3-6 Minatojima Chuo-ku Kobe-shi Hyogo, Japan

TEL

078-304-3189

Email

moakiko@huhs.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Mori

Organization

Hyogo University of Health Sciences

Division name

Department of Physical Therapy, School of Rehabilitation

Zip code

650-8530

Address

1-3-6 Minatojima Chuo-ku Kobe-shi Hyogo, Japan

TEL

078-304-3189

Homepage URL


Email

moakiko@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo University of Health Sciences

Institute

Department

Personal name



Funding Source

Organization

Hyogo University of Health Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hyogo University of Health Sciences

Address

1-3-6 Minatojima Chuo-ku Kobe-shi Hyogo, Japan

Tel

078-304-3189

Email

moakiko@huhs.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

2021 Year 08 Month 03 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

2021 Year 06 Month 01 Day

Date of IRB

2021 Year 06 Month 01 Day

Anticipated trial start date

2021 Year 08 Month 25 Day

Last follow-up date

2022 Year 12 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 08 Month 03 Day

Last modified on

2023 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051465


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name