UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043971 |
|---|---|
| Receipt number | 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 | 2023/10/24 06:20:11 |
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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
| Obstetrics 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 Medical University
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
moakiko@hyo-med.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
inoue@met.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Physical Therapy, School of Rehabilitation, Hyogo Medical University
Institute
Department
Personal name
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 Medical University
Address
1-3-6 Minatojima Chuo-ku Kobe-shi Hyogo, Japan
Tel
078-304-3189
moakiko@hyo-med.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
Open public recruiting
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
| 2025 | Year | 03 | 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
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050224
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
