JRCT ID: jRCT1032250610
Registered date:05/01/2026
Evaluation of the effects of transperineal skeletal muscle electrical stimulation on pelvic floor muscle group strength.
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Stress Urinary Incontinence Symptoms |
| Date of first enrollment | 09/01/2026 |
| Target sample size | 10 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Participants will perform training at home using a seated-type EMS device once daily for 15 minutes, as consistently as possible. The intervention period will be 12 weeks, and training may be performed at any time of day. |
Outcome(s)
| Primary Outcome | Pelvic floor muscle contraction strength and pelvic floor muscle contraction duration (measured using a portable ultrasound imaging device). |
|---|---|
| Secondary Outcome | 1.Pelvic floor muscle position assessed by MRI 2.Records of EMS device usage 3.Interview-based subjective assessments |
Key inclusion & exclusion criteria
| Age minimum | >= 30age old |
|---|---|
| Age maximum | <= 59age old |
| Gender | Female |
| Include criteria | 1.Women aged 30-59 years at the time of informed consent who have a history of childbirth. 2.Individuals who experience symptoms of stress urinary incontinence (urine leakage during sneezing, coughing, or physical activity) at least twice per week. 3.Individuals who are physically and mentally healthy. 4.Individuals who are able to use the EMS device on a daily basis in principle during the study period. 5.Individuals who are able to complete daily usage records throughout the study period. |
| Exclude criteria | 1.Individuals with a history of treatment for urinary incontinence or pelvic organ disorders, or a history of surgery involving the pelvic organs, urinary tract, or rectum. 2.Individuals who are currently performing pelvic floor muscle training. 3.Individuals who are pregnant or within one year postpartum. 4.Individuals with voiding dysfunction due to neurological disorders, or with a history of or current symptoms of cerebrovascular disease or neurological disorders (e.g., epilepsy). 5.Individuals with a history of heart disease, those with current or suspected cardiac symptoms, those receiving treatment for hypertension, individuals with venous thrombosis or suspected venous thrombosis, or those using a pacemaker. 6.Individuals with malignant tumors. 7.Individuals who have difficulty communicating in Japanese or completing questionnaires in Japanese. 8.Individuals who are deemed inappropriate for participation in the study by the investigator for any other reason. 9.Individuals who do not meet the safety criteria required for MRI examination. |
Related Information
| Primary Sponsor | Okayama Hisayo |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Hisayo okayama |
| Address | 1-1-1 Tennodai, Tsukuba , Ibaraki, Japan, Ibaraki Japan 305-8577 |
| Telephone | +81-29-853-8372 |
| okayama@md.tsukuba.ac.jp | |
| Affiliation | University of Tsukuba |
| Scientific contact | |
| Name | Hisayo Okayama |
| Address | 1-1-1 Tennodai, Tsukuba , Ibaraki, Japan Ibaraki Japan 305-8577 |
| Telephone | +81-29-853-8372 |
| okayama@md.tsukuba.ac.jp | |
| Affiliation | University of Tsukuba |