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临床试验/NCT05693103
NCT05693103招募中不适用

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

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Urodynamic study

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Urodynamic study

时间窗: 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

时间窗: five minutes

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

Questionnaire

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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