Stress urinary incontinence Stress urinary incontinence
Conditions
Interventions
Intervention group: Participants will use the investigational EMS device applied transperineally for 15 minutes once daily over 12 consecutive weeks. The stimulation intensity is adjustable across 25
Electrical Muscle Stimulation device , Pelvic Floor Muscle Training
Sponsors
Okayama Hisayo
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Individuals who are female, aged 30 years or older and under 59 years, with a history of childbirth. 2.Individuals who experience symptoms of stress urinary incontinence at least twice per week. 3.Individuals who have a urine leakage volume of 1 grams or more on the 1-hour pad test conducted during the pre-observation period. 4.Individuals whose body mass index (BMI) is 18.5 or greater and less than 25. 5.Individuals who, after receiving sufficient explanation about this study and demonstrating adequate understanding, voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Participants with a history of treatment for urinary incontinence or pelvic organ disorders, or a history of surgery on the pelvic organs, urinary tract, or rectum. 2.Participants currently performing pelvic floor muscle training. 3.Participants who are pregnant or within one year postpartum. 4.Participants with voiding dysfunction due to neurological disorders, or with a history or symptoms of cerebrovascular or neurological diseases (e.g., epilepsy). 5.Participants with a history or current symptoms of heart disease, suspected heart disease, hypertension under treatment, venous thrombosis or suspected thrombosis, or use of a pacemaker. 6.Participants with malignant tumors. 7.Participants who have difficulty communicating in Japanese or responding to questionnaires. 8.Participants judged by the principal investigator or sub-investigator to be inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary incontinence improvement rate: Participants will be considered "improved" if either the weekly frequency of urinary incontinence episodes or the urinary leakage volume in the 1-hour pad test decreases by thirty percent or more compared with baseline. The proportion of participants meeting this criterion will be defined as the urinary incontinence improvement rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.1-hour pad test (urinary leakage volume absorbed over 60 minutes) 2.International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) 3.King's Health Questionnaire(KHQ) 4.Daily record sheets documenting the frequency and circumstances of urination and urinary incontinence, training adherence, and the presence or absence of menstruation | — |
Contacts
Public Contacthisayo okayama
University of Tsukuba
Outcome results
None listed