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

Recruiting

• Conditions: Urinary Incontinence, Stress Incontinence
• Interventions: Device: High-Intensity Focused Electromagnetic therapy

• Registration Number: NCT05693103
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-15
• Status Verified: 2022-12
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-20
• Last Update Posted: 2023-01-20
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Women over 20 years old.
2. Symptoms of urinary incontinence (including: stress incontinence, urge incontinence).
3. Blood tests confirmed that the number of platelets was 150,000-450,000/UL, and the coagulation function (PT) index was normal.

Exclusion Criteria

1. Pregnant and lactating women.
2. Patients with acute or chronic cardiovascular disease.
3. Patients with acute or chronic infectious diseases.
4. Patients with malignant tumors, uterine fibroids, and gynecological cysts, who have been evaluated by doctors as unsuitable.
5. Those who have undergone lower abdominal or genital-related surgery and have been evaluated by doctors as unsuitable.
6. Patients with pulmonary insufficiency.
7. People with metal and electronic implants (such as: pacemaker, defibrillator, neurostimulator).
8. Those with bleeding disorders or receiving anticoagulant therapy.
9. Use drug pumps.
10. People with skin allergies or skin diseases.
11. Those unable to sign the subject's consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Urinary Incontinence	High-Intensity Focused Electromagnetic therapy	Stress Urinary Incontinence Urge incontinence

Primary Outcome Measures

Name	Time	Method
Urodynamic study	One hour	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.
Physiological parameter	five minutes	Age, BMI in kg/m\^2, Pregnancy and childbirth, Year of Symptoms
Questionnaire	fifteen minutes	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.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan