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

NCT05693103 | Unknown FDA Device

• 1 other identifier: KMUHIRB-F(I)-20210133
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Stress Incontinence

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Urinary Incontinence

Stress Urinary Incontinence Urge incontinence

Device: High-Intensity Focused Electromagnetic therapy

Interventions

High-Intensity Focused Electromagnetic therapy 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.

Also known as: EMSELLA

Urinary Incontinence

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Women with stress urinary incontinence, urge incontinence.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cheng-Yu Long, PhD

CONTACT

+ 886 7 3121101; urolong@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 20, 2023
• Study Start: August 15, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 20, 2023

Record last verified: 2022-12

Locations

TW (1)