UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| 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 | 2020/09/07 (Ver. 7) |
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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 | |
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| Condition | |||
| Condition | urinary incontinence | ||
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| Target sample size | 20 | |||
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| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 | 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| 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. |
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| Participant flow | Twenty women who gave consent were randomly allocated to walking(drop out3) or no walking groups. |
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| Adverse events | Nothing special |
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| 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. |
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| Recruitment status | Completed | ||||||
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| Other | |
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| Management information | |||||||
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029812 |
