Verification of the effect of the gluteus maximus muscle training with electrical stimulation on the pelvic floor muscles.

UMIN ID: UMIN000055979

Registered date:30/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy women in their 30s to 50s who have delivered before
• Date of first enrollment: 2024/10/17
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The study subjects will wear the SIXPAD Hip Fit. The intervention period will be 12 weeks and will be worn daily for 23 minutes.

Outcome(s)

• Primary Outcome: Pelvic floor muscle measurements (pelvic floor muscle contraction force and pelvic floor muscle contraction time) The evaluation periods will be pre-intervention, 6 weeks post-intervention, and 12 weeks post-intervention.

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 60years-old
• Gender: Female
• Exclude criteria: Those who have received treatment for pelvic organs or urinary incontinence at a medical institution. Persons with electromagnetic hypersensitivity (physical symptoms such as headache, dizziness, nausea, etc., caused by the use of electrical appliances such as cell phones, computers, wireless LAN, induction cookers, microwave ovens, etc.) Pacemaker users Those who have a history of pelvic organ prolapse or pelvic organ abdominal surgery (excluding cesarean section) Pregnant women and women within 1 year postpartum Patients with urinary incontinence due to neurological disorders Patients with a history of cerebrovascular disease or neurological disease. Those who are out of the standard size range of Hip Fit. Those who are undergoing pelvic floor muscle training. Those who have difficulty communicating in Japanese or answering questionnaires. Those who have difficulty in coming to the hospital for pelvic floor muscle measurement on the designated date. Those who have contraindications to the use of Hip Fit and those who need to consult a physician.

Related Information

• Primary Sponsor: University of Tsukuba
• Secondary Sponsor: Osaka Medical and Pharmaceutical University
• Source(s) of Monetary Support: MTG Corporation