UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043520 |
|---|---|
| Receipt number | R000049663 |
| Scientific Title | Effect of voluntary contraction of pelvic floor muscle on blood flow in uterine artery |
| Date of disclosure of the study information | 2021/03/05 |
| Last modified on | 2023/03/07 11:56:08 |
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Basic information
Public title
Effect of voluntary contraction of pelvic floor muscles on blood flow in uterine artery
Acronym
Effect of pelvic floor muscles on Uterine Arteries
Scientific Title
Effect of voluntary contraction of pelvic floor muscle on blood flow in uterine artery
Scientific Title:Acronym
Effect of pelvic floor muscles on Uterine Arteries
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Obstetrics and Gynecology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we focused on the pelvic floor muscle innervating the internal pudendal artery, which runs in the vicinity of the uterine artery, and aimed to verify the effect of voluntary contraction of the pelvic floor muscle on the blood flow of the uterine artery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Time Averaged Mean Velocity,Time Averaged Maximum Velocity
Key secondary outcomes
Pulsatility Index,Resistance Index,The amount of elevation of the lower end of the bladder base
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Measurement of basal body temperature will begin at least one month prior to the data measurement date to predict the menstrual, proliferative, and secretory phases. In parallel, voluntary contraction exercises of the pelvic floor muscle will be performed. To confirm the voluntary contraction of the pelvic floor muscle , the lower end of the bladder base will be drawn by transabdominal ultrasonography, and the contraction will be confirmed by raising the bladder base, and the amount of raising at the time of maximum voluntary contraction will be measured. Time Averaged Mean Velocity,Time Averaged Maximum Velocity, Pulsatility Index, and Resistance Index of the pelvic floor muscle before and after voluntary contraction will be measured by transvaginal ultrasonography during the menstrual - proliferative phase and the secretory phase of each study subject.
Interventions/Control_2
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy adult women between the ages of 20 and 45 who have menstrual periods.
Key exclusion criteria
Those who have organic gynecological diseases (symptoms caused by uterine fibroids, chocolate cysts larger than 4 cm)
Those who are taking medication related to menstruation, such as oral contraceptives or analgesic.
Menstrual irregularities
Those with a history of gynecological surgery.
Those who have never had sexual intercourse.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Mori |
Organization
Hyogo Medical University
Division name
School of Rehabilitation
Zip code
6508530
Address
1-3-6 Minatojima, Chuo-ku, Kobe City, Hyogo
TEL
078-304-3000
moakiko@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Urushikawa |
Organization
LUTIS
Division name
Owner
Zip code
810-0074
Address
1-4-15-1104 otemon,chuo-ku,Fukuoka City,Fukuoka
TEL
090-4991-7152
Homepage URL
whh.company2017@gmail.com
Sponsor or person
Institute
Hyogo University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
clinical research incentive fund(pending)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hyogo College Of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University Ethics Review Board
Address
1-3-6 Minatojima, Chuo-ku, Kobe City, Hyogo
Tel
078-304-3000
ya-sasahara@huhs.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
兵庫医療大学（兵庫県）Hyogo University of Medical Science (Hyogo, Japan)
兵庫医科大学病院（兵庫県）Hyogo Medical University Hospital (Hyogo, Japan)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 05 | 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
13
Results
There were no main effects or interactions for time-averaged maximum velocity. There was a main effect of contraction of the pelvic floor muscles before and after contraction on time-averaged mean velocity, which increased significantly after contraction compared to before (p=0.023).
Results date posted
| 2022 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The basic attributes were age 31.1 years, and age at menarche 12.4 years.The menstrual cycle and duration of menstruation were all within normal limits.
Participant flow
Thirteen participants were included in the study, and 8 were eligible for analysis, excluding 5 who were excluded. The exclusions included 1 participant who discontinued the experiment due to irregular bleeding, 1 participant who withdrew consent, 1 participant who had anovulatory cycles, and 2 participants with missing data.
Adverse events
None
Outcome measures
Two-way analysis of variance was used to test for differences in time-averaged maximum velocity, time-averaged mean velocity, Pulsatility Index, and Resistance Index during menstruation and before and after contraction of the pelvic floor muscle group.No main effects were found for time-averaged maximum flow velocity, Pulsatility Index, or Resistance Index. There was a main effect of contraction of the pelvic floor muscle group before and after the contraction of the pelvic floor muscles on the time-averaged mean velocity.
Pearson's correlation coefficient was used to correlate the change in time-averaged maximum velocity and time-averaged mean velocity before and after pelvic floor muscles contraction with the rate of pelvic floor elevation. No relationship was found between the change in time-averaged maximum velocity or time-averaged mean velocity and the rate of pelvic floor elevation.
Plan to share IPD
There is no Plan to share IPD.
IPD sharing Plan description
There is no Plan to share IPD.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049663
