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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043971
Receipt No. R000050224
Scientific Title Effects of pelvic floor muscle training for patients with stress urinary incontinence - a randomized controlled trial -
Date of disclosure of the study information 2021/05/01
Last modified on 2021/09/29

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Basic information
Public title Effects of pelvic floor muscle training for patients with stress urinary incontinence - a randomized controlled trial -
Acronym Effects of pelvic floor muscle training for patients with stress urinary incontinence - a randomized controlled trial -
Scientific Title Effects of pelvic floor muscle training for patients with stress urinary incontinence - a randomized controlled trial -
Scientific Title:Acronym Effects of pelvic floor muscle training for patients with stress urinary incontinence - a randomized controlled trial -
Region
Japan

Condition
Condition Stress urinary incontinence
Classification by specialty
Obsterics and gynecology Urology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate the effects of 12-week pelvic floor muscle training on urinary incontinence in patients with stress urinary incontinence.
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 12 weeks
Key secondary outcomes 24-hour pad test (amount of urinary leakage)
King's Health Questionnaire
Overactive Bladder Symptoms Score
3-day bladder diary (incontinence frequency, number of micturition, number of pad use)
Vaginal pressure
Patient Global Impression of Improvement
Questionnaire (further treatment)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intervention group: Pelvic floor muscle training and lifestyle advice for 12 weeks
Interventions/Control_2 Control group: Lifestyle advice
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 with stress urinary incontinence at least two episodes of urinary incontinence per week or mixed urinary incontinence with predominantly stress urinary incontinence
Key exclusion criteria Patients with severe pelvic organ prolapse
Those who have undergone urological or urogynecological surgery radiotherapy, total hysterectomy, suffering from mental illness, neurological disorders, disable to understand explanations or currently being pregnant
Those who have undergone or are currently undergoing pelvic floor muscle training in a medical institution and drug treatment
Those who will start pelvic floor muscle training and drug treatment at the same time
Target sample size 36

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 650-8530
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 Tomoe
Middle name
Last name Inoue
Organization Nagoya University Graduate School of Medicine
Division name Department of Integrated Health Sciences
Zip code 461-8673
Address 1-1-20 Daiko-Minami, Higashi-ku, Nagoya, Aichi, Japan
TEL 052-719-1365
Homepage URL
Email inoue@met.nagoya-u.ac.jp

Sponsor
Institute Department of Physical Therapy, School of Rehabilitation, Hyogo University of Health Sciences
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

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 05 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 27 Day
Date of IRB
2020 Year 10 Month 27 Day
Anticipated trial start date
2021 Year 10 Month 01 Day
Last follow-up date
2022 Year 12 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 04 Month 19 Day
Last modified on
2021 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050224

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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