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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05693103
Collaborator
(none)
30
1
34.5
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High-Intensity Focused Electromagnetic therapy

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
The Effect of High-Intensity Focused Electromagnetic on Urinary Incontinence Symptoms
Actual Study Start Date :
Aug 15, 2021
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Urinary Incontinence

Stress Urinary Incontinence Urge incontinence

Device: 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.
Other Names:
  • EMSELLA
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. Physiological parameter [five minutes]

      Age, BMI in kg/m^2, Pregnancy and childbirth, Year of Symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807

    Sponsors and Collaborators

    • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT05693103
    Other Study ID Numbers:
    • KMUHIRB-F(I)-20210133
    First Posted:
    Jan 20, 2023
    Last Update Posted:
    Jan 20, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 20, 2023