UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025165 |
|---|---|
| Receipt number | R000028948 |
| Scientific Title | A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training for primiparous and multiparous women. (Sango-PFMT Trial) |
| Date of disclosure of the study information | 2016/12/06 |
| Last modified on | 2018/06/08 09:23:28 |
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Basic information
Public title
A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training for primiparous and multiparous women. (Sango-PFMT Trial)
Acronym
A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training. (Sango-PFMT Trial)
Scientific Title
A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training for primiparous and multiparous women. (Sango-PFMT Trial)
Scientific Title:Acronym
A randomized controlled trial of transabdominal ultrasound biofeedback in postpartum pelvic floor muscle training. (Sango-PFMT Trial)
Region
| Japan |
Condition
Condition
Pelvic floor muscle dysfunction
Urinary stress incontinence
Anal incontinence
Fecal incontinence
Classification by specialty
| Obstetrics and Gynecology | Urology | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate effectiveness of postpartum pelvic floor muscle training with transabdominal ultrasound biofeedback for the recovery of pelvic floor muscle function in primiparous and multiparous women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of pelvic floor muscle function using ultrasounds
Key secondary outcomes
1) Ultrasound evaluation of the success rate in the pelvic floor muscle contraction at each lesson
2) Questionnaires
Pelvic floor distress inventory-20 (PFDI-20)
Fecal incontinence severity index (FISI)
International consultation on incontinence questionnaire-short form (ICIQ-SF)
Fatigue feelings (Jikakusho shirabe)
Fecal incontinence quality of life scale (FIQL)
Wexner score
Incontinence quality of life (I-QOL)
Pelvic floor muscle exercise self-efficacy scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Postpartum pelvic floor muscle training with transabdominal ultrasound biofeedback
Interventions/Control_2
Postpartum pelvic floor muscle training without transabdominal ultrasound biofeedback
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
Postpartum women
Key exclusion criteria
1) with a history of cesarean section, multiple birth or breech delivery
2) with an experience of incontinence before pregnancy
3) with neuropathic urinary and fecal incontinence
4) with restricted physical activity
5) less than 20 years old
Target sample size
164
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Megumi Haruna |
Organization
The University of Tokyo
Division name
Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
03-5841-3396
mharuna-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Haruna |
Organization
The University of Tokyo
Division name
Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
03-5841-3396
Homepage URL
mharuna-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 12 | Month | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2018 | 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
| 2016 | Year | 12 | Month | 06 | Day |
Last modified on
| 2018 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028948
