UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025931 |
|---|---|
| Receipt number | 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 | 2020/09/07 17:17:19 |
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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
| Obstetrics 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 | Teruko |
| Middle name | |
| Last name | Komatsu |
Organization
Kochi Medical School
Division name
Nursing Couse
Zip code
783-8505
Address
Kohasu Oko-cho Nannkoku, Kochi 783-8505, Japan
TEL
088-880-2520
teruko-komatsu@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Teruko |
| Middle name | |
| Last name | Komatsu |
Organization
Kochi Medical School
Division name
Nursing Couse
Zip code
783-8505
Address
Kohasu Oko-cho Nannkoku, Kochi 783-8505, Japan
TEL
088-880-2520
Homepage URL
teruko-komatsu@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
Ethical Review Board of Kochi Medical School
Address
Kohasu Oko-cho Nankoku-shi Kochi
Tel
088-880-2180
is21@kochi-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
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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
20
Results
No statistically significant difference in the pelvic measurements for urinary incontinence was observed between the walking and no walking groups.No statistically significant difference in the ICIQ-SF scores for urinary incontinence was observed between the walking and no walking groups. Urinary incontinence symptoms worsened in 3 of the 10 subjects in the non-exercise group, but improved or resolved in all subjects in the walking exercise group.
Results date posted
| 2020 | Year | 09 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty women who experienced urinary incontinence between the first trimester of pregnancy and 1 month postpartum.
Participant flow
Twenty women who gave consent were randomly allocated to walking(drop out3) or no walking groups.
Adverse events
Nothing special
Outcome measures
Primary outcomes: Improvement of pelvic measurement from 1 month after delivery (approaching at 12 weeks of pregnancy).
Key secondary outcomes: The amount of change of the pat test, the number of times (ICIQ-SF scores) of the incontinence of urine.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 10 | Day |
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
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029812
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