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

January 11, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Collect 30 women with urinary incontinence symptoms (including: stress urinary incontinence, urge urinary incontinence)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urodynamic study
Time Frame: 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.
One hour
Questionnaire
Time Frame: 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.
fifteen minutes
Physiological parameter
Time Frame: five minutes
Age, BMI in kg/m^2, Pregnancy and childbirth, Year of Symptoms
five minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(I)-20210133

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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