The Efficacy of High-Intensity Focused Ultrasound Therapy on Adenomyosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dysmenorrhea
研究概览
简要总结
To assess the efficacy of High-Intensity Focused Ultrasound on adenomyosis
详细描述
Patients and methods:
All outpatient patients with adenomyosis who will receive High-Intensity Focused Ultrasound therapy will be invited to participate in this study. The size and location of adenomyosis and the uterus should be assessed by ultrasonography. Besides, all enrolled female patients will be asked to complete visual analog scale of the severity of dysmenorrhea and the intensity of menstrual bleeding, overactive bladder symptom score, female bladder function (UDI-6 & IIQ-7), female sexual function index, and bowel incontinence assessment questionnaires. In addition, patients who underwent surgeries for myoma or adenomyosis will be requested to complete the above questionnaires and ultrasound examination at 3 months and 6 months after therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must be at least 18 years old.
- •Adenomyosis: There must be several dark areas on at least one side of the uterine wall; the uterine wall must be thickened; in addition, the thickened uterine wall must have a nonhomogeneous structure; and clinically, there must be dysmenorrhea or menorrhagia.
排除标准
- •The patient currently has an acute lower urinary tract infection or intestinal inflammation.
- •The patient has previously undergone bladder or urethral surgery.
- •The patient has a history of urinary tract stones or tumors.
研究组 & 干预措施
Adenomyosis
adenomyosis of the uterus
干预措施: High Intensity Focused Ultrasound (Procedure)
结局指标
主要结局
Dysmenorrhea
时间窗: 6 months
The changes of VAS scores of dysmenorrhea
次要结局
- Menorrhagia(6 months)
- Overactive bladder symptoms(6 months)
- Female sexual function(6 months)
- Bowel incontinence(6 months)
- Overall condition of dysmenorrhea(6 months)
- Overall condition in menorrhagia(6 months)
研究者
Sheng-Mou Hsiao, MD
Chief of Department of Obstetrics and Gynecology
Far Eastern Memorial Hospital