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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025931
Receipt No. R000029812
Scientific Title The effect of walking exercise on pelvic function in women with urinary incontinence due to pregnancy / labor
Date of disclosure of the study information 2017/01/31
Last modified on 2018/08/06

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Basic information
Public title The effect of walking exercise on pelvic function in women with urinary incontinence due to pregnancy / labor
Acronym The effect of walking exercise on pelvic function in women with urinary incontinence due to pregnancy / labor
Scientific Title The effect of walking exercise on pelvic function in women with urinary incontinence due to pregnancy / labor
Scientific Title:Acronym The effect of walking exercise on pelvic function in women with urinary incontinence due to pregnancy / labor
Region
Japan

Condition
Condition urinary incontinence
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of the walking exercise for women with urinary incontinence due to pregnancy / labor in their 20s to 30s, with focus on changes in pelvic morphology
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Pelvic morphology: intertrochanteric diameter; external conjugate diameter; pelvic inclination
Key secondary outcomes Presentation of urinary incontinence: the amount / frequency of urinary incontinence; urinary incontinence specific quality of life

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 YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 4 months walking exercise
Interventions/Control_2 no walking exercise
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
40 years-old >
Gender Female
Key inclusion criteria Healthy pregnant women, aged older than 20 years and younger than 40 years, with urinary incontinence during pregnancy or 4 weeks postpartum
Key exclusion criteria 1.Women with neurological or psychiatric diseases which may induce falling (e.g., epilepsy, myelopathy, cranial nerve diseases, mental disorder)
2.Women with multiple pregnancy, or complicating baby postpartum
3.Women restricted in exercise by their doctors at the medical examination 4 weeks postpartum (e.g., intrapartum abnormal hemorrhage, anemia, high blood pressure, perineal laceration IV degree, postpartum mental disorder)
4. Women having no enough time for the walking exercise
5. Women scored over 9 points for Edinburgh Postpartum Depression Scale at the medical examination 4 weeks postpartum
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruko Komatsu
Organization Kochi Medical School
Division name Nursing Couse
Zip code
Address Kohasu Oko-cho Nannkoku, Kochi 783-8505, Japan
TEL 088-880-2520
Email teruko-komatsu@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruko Komatsu
Organization Kochi Medical School
Division name Nursing Couse
Zip code
Address Kohasu Oko-cho Nannkoku, Kochi 783-8505, Japan
TEL 088-880-2520
Homepage URL
Email teruko-komatsu@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

Funding Source
Organization the Ministry of Education, Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor 1.Kochi Family Clinic
2.Kunimi birth clinic
3.Asai birth clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 1.高知大学医学部附属病院(高知県)/ Kochi Medical School Hospital(Kochi)
2.高知ファミリークリニック(高知県)/ Kochi Family Clinic(kochi)
3.国見産婦人科(高知県)/ Kunimi birth clinic(kochi)
4.浅井産婦人科(高知県)/ Asai birth clinic(kochi)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 31 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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 31 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029812

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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