The Effect of High-Intensity Focused Electromagnetic on Urinary Incontinence Symptoms

Study Overview
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Brief Summary
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This study is aimed at women's pelvic floor muscles, especially urinary incontinence caused by pelvic floor muscle relaxation or pelvic prolapse, to observe whether the use of (HIFEM) high-intensity focused magnetic energy chairs can help the pelvic floor muscles after this treatment Strengthening to improve the symptoms of urinary incontinence caused by the compression of the sacral nerve plexus caused by the downward movement of the uterus, thereby improving the social life and quality of life of the patient.

Official Title
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The Effect of High-Intensity Focused Electromagnetic on Urinary Incontinence Symptoms

Conditions
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Urinary Incontinence, Stress Incontinence

Intervention / Treatment
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* Device: High-Intensity Focused Electromagnetic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over 20 years old. Symptoms of urinary incontinence (including: stress incontinence, urge incontinence). Blood tests confirmed that the number of platelets was 150,000-450,000/UL, and the coagulation function (PT) index was normal. Exclusion Criteria: Pregnant and lactating women. Patients with acute or chronic cardiovascular disease. Patients with acute or chronic infectious diseases. Patients with malignant tumors, uterine fibroids, and gynecological cysts, who have been evaluated by doctors as unsuitable. Those who have undergone lower abdominal or genital-related surgery and have been evaluated by doctors as unsuitable. Patients with pulmonary insufficiency. People with metal and electronic implants (such as: pacemaker, defibrillator, neurostimulator). Those with bleeding disorders or receiving anticoagulant therapy. Use drug pumps. People with skin allergies or skin diseases. Those unable to sign the subject's consent form.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Urinary Incontinence<br>Stress Urinary Incontinence Urge incontinence | Device: High-Intensity Focused Electromagnetic therapy<br>* The HPM-6000UF is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The electromagnetic field delivered in the muscular or neuronal tissue area is triggering the stimulation and tonisation.<br>* Other names: EMSELLA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic study | Urodynamic testing is any procedure that looks at how well parts of the lower urinary tract-the bladder, sphincters, and urethra-work to store and release urine. Most urodynamic tests focus on how well your bladder can hold and empty urine. Urodynamic tests can also show whether your bladder is contracting when it's not supposed to, causing urine to leak. | One hour | 
| Questionnaire | Female Sexual Function Index, International Consultation on Incontinence Questionnaire, Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, The International Consultation on Incontinence, Pelvic Organ Prolapse Distress Inventory-6, Overactive Bladder Symptom Score, The global response assessment. | fifteen minutes | 
| Physiological parameter | Age, BMI in kg/m^2, Pregnancy and childbirth, Year of Symptoms | five minutes |