UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044384
Receipt number R000049464
Scientific Title Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior
Date of disclosure of the study information 2021/06/02
Last modified on 2024/03/14 15:34:38

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Basic information

Public title

Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior

Acronym

Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior

Scientific Title

Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior

Scientific Title:Acronym

Effect of changes in urinary incontinence symptoms due to self-exercise on economic behavior

Region

Japan


Condition

Condition

healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Whether the presence or absence of urinary incontinence symptoms makes a difference in economic activity

Basic objectives2

Others

Basic objectives -Others

Improvement of Urinary Incontinence Symptoms Affects Quality of Life and Economic Activity

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

ICIQ-SF , quality of life, physical activity, and economic behavior

Key secondary outcomes

1.Exercise frequency during the intervention period

2.History of urology-related hospital visits, medication, and treatment during the intervention period


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Fifteen-minute exercises, focusing on pelvic floor muscles exercises, three times a week

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Those who are 40 years old or older at the time of obtaining informed consent and reside in Hiroshima Prefecture
2. Those who can provide written informed consent for this study

Key exclusion criteria

1. Patients who are undergoing urological treatment or medication at the time of obtaining informed consent
2. Those who are pregnant
3. Others who are regarded as unsuitable by the researcher to conduct this research

Target sample size

250


Research contact person

Name of lead principal investigator

1st name Maeda
Middle name
Last name Noriaki

Organization

Graduate School of Biomedical & Health Sciences, Hiroshima University

Division name

Department of Sports Rehabilitation

Zip code

734-8553

Address

1-2-3,Kassumi,Minamiku,Hiroshima,Japan

TEL

082-257-5410

Email

norimmi@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Maeda
Middle name
Last name Noriaki

Organization

Graduate School of Biomedical & Health Sciences, Hiroshima University

Division name

Department of Sports Rehabilitation

Zip code

734-8553

Address

1-2-3,Kassumi,Minamiku,Hiroshima,Japan

TEL

082-257-5410

Homepage URL


Email

norimmi@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Hiroshima University

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School of Biomedical & Health Sciences, Hiroshima University

Address

1-2-3,Kassumi,Minamiku,Hiroshima,Japan

Tel

082-257-5410

Email

norimmi@hiroshima-u.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 06 Month 02 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

0

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

Terminated

Date of protocol fixation

2021 Year 03 Month 17 Day

Date of IRB

2021 Year 04 Month 20 Day

Anticipated trial start date

2021 Year 04 Month 21 Day

Last follow-up date

2024 Year 05 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

2021 Year 05 Month 31 Day

Last modified on

2024 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049464


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name