UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061484 |
|---|---|
| Receipt number | R000070269 |
| Scientific Title | Elucidation of the Mechanisms Underlying the Effects of Surface Electrical Stimulation on Pelvic Floor Muscle Contraction Characteristics in Nulliparous Women |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/07 21:58:25 |
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Basic information
Public title
Elucidation of the Mechanisms Underlying the Effects of Surface Electrical Stimulation on Pelvic Floor Muscle Contraction Characteristics in Nulliparous Women
Acronym
Elucidation of the Mechanisms Underlying the Effects of Surface Electrical Stimulation on Pelvic Floor Muscle Contraction Characteristics in Nulliparous Women
Scientific Title
Elucidation of the Mechanisms Underlying the Effects of Surface Electrical Stimulation on Pelvic Floor Muscle Contraction Characteristics in Nulliparous Women
Scientific Title:Acronym
Elucidation of the Mechanisms Underlying the Effects of Surface Electrical Stimulation on Pelvic Floor Muscle Contraction Characteristics in Nulliparous Women
Region
| Japan |
Condition
Condition
Nulliparous Women with Difficulty in Pelvic Floor Muscle Contraction
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the mechanisms by which surface electrical stimulation of the pudendal nerve affects pelvic floor muscle contraction in nulliparous women with difficulty in pelvic floor muscle contraction.
Basic objectives2
Others
Basic objectives -Others
Association Between Pelvic Floor Muscle Contraction and the Muscle Activity of Other Muscle Groups
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tissue mobility during pelvic floor muscle contraction after each stimulation session (Displacement distance of the anorectal angle / Change in the anorectal angle).
Key secondary outcomes
Pelvic Floor Muscle Stiffness (Shear elastic modulus of the Levator Ani Muscle)
Muscle Activity of Muscles Other Than the Pelvic Floor Muscles (External Oblique Muscle / Internal Oblique Muscle / Adductor Magnus / Gluteus Maximus)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention: Electrical stimulation at the maximum tolerable level combined with voluntary pelvic floor muscle contractions (5 seconds of electrical stimulation with contraction followed by 10 seconds of relaxation, repeated 10 times per session, for a total of 3 sessions).
Interventions/Control_2
Control condition: Voluntary pelvic floor muscle contractions (5 seconds of contraction followed by 10 seconds of relaxation, repeated 10 times per session, for a total of 3 sessions).
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Nulliparous women aged 18-30 years
Key exclusion criteria
(1) Pregnancy or a history of childbirth
(2) History of or current treatment for gynecological diseases
(3) Participation in professional sports activities
(4) BMI of 30 kg/m2or higher
(5) Sensory impairment in the perineal region
(6) Skin damage or inflammation in the perineal region
(7) Metal or plastic implants in the perineal region
(8) History of epilepsy, urinary tract infection, bleeding disorders, neurological abnormalities, or psychiatric treatment
(9) History of orthopedic disorders related to the spine, pelvic girdle, or hip joint
(10) Vascular disorders such as thrombosis, venous thrombosis, or varicose veins
(11) Use of implanted electronic devices such as a pacemaker
(12) Acute painful conditions of unknown origin
(13) Cardiac disorders or malignant tumors
(14) Febrile or infectious diseases
(15) During menstruation
(16) Ability to voluntarily contract the pelvic floor muscles
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Yokoi |
Organization
Josai International University
Division name
Graduate School of Health Sciences
Zip code
283-0002
Address
1 Gumyo, Togane-shi, Chiba, Japan
TEL
0475-55-8800
yokoi@jiu.ac.jp
Public contact
Name of contact person
| 1st name | Rina |
| Middle name | |
| Last name | Katagiri |
Organization
Josai International University
Division name
Graduate School of Health Sciences
Zip code
283-0002
Address
1 Gumyo, Togane-shi, Chiba, Japan
TEL
0475-55-8800
Homepage URL
mh25-005@jiu.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Josai International University
Address
1 Gumyo, Togane-shi, Chiba, Japan
Tel
0475-55-8800
yokoi@jiu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070269
