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Clinical Trials/NCT05693103
NCT05693103
Recruiting
Not Applicable

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

Kaohsiung Medical University Chung-Ho Memorial Hospital1 site in 1 country30 target enrollmentAugust 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence, Stress Incontinence
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Enrollment
30
Locations
1
Primary Endpoint
Urodynamic study
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2021
End Date
June 30, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Physiological parameter

Time Frame: five minutes

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

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.

Study Sites (1)

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