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

NCT ID: NCT05693103

Last Updated: 2023-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-15

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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Urinary Incontinence, Stress Incontinence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Urinary Incontinence

Stress Urinary Incontinence Urge incontinence

High-Intensity Focused Electromagnetic therapy

Intervention Type DEVICE

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.

Interventions

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High-Intensity Focused Electromagnetic therapy

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.

Intervention Type DEVICE

Other Intervention Names

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EMSELLA

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Cheng-Yu Long, PhD

Role: CONTACT

+ 886 7 3121101 ext. 6428

Facility Contacts

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Cheng-Yu Long, PhD

Role: primary

+886-7-3121101 ext. 6428

Other Identifiers

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KMUHIRB-F(I)-20210133

Identifier Type: -

Identifier Source: org_study_id

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