Dienogest Versus Uterine Artery Embolization in Ttt of Adenomyosis -cohort Comparetive Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- evaluation use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire
研究概览
简要总结
to evaluate use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms
详细描述
Type of the study: prospective cohort comparative study. Setting: It will be done at both Obstetrics & Gynecology department and Radiology department, Al-Azhar University Hospital Assiut branch.
Time of the study: Starting from January 2025 till the end of the study Number of cases: 100 cases. According to sample size equation Where; in: n = number of patients, = 1.96 (standard normal deviate value that divides the central 95% of z distribution from 5% in the tails), P = the reported sensitivity (67%, i.e., 0.67), L= absolute precision desired on either side (half width of the confidence interval of the confidence interval) of sensitivity (10% i.e., 0.1).
Inclusion criteria:
- Age Group: 30-50 years
- Women with adenomyosis
- With or without small fibroids
- Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age Group: 30-50 years
- •Women with adenomyosis
- •With or without small fibroids
- •Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.
排除标准
- •- Presence of a malignancy or pelvic infection.
- •An on-going pregnancy or a desire to conceive in the future.
- •Absolute contraindication for angiography (renal impairment).
- •Chronic debilitating diseases.
研究组 & 干预措施
Dienogest group
will take 2 mg oral Dienogest
干预措施: Dienogest 2 mg orally (Drug)
Uterine artery embolization
will undergoes uterine artery embolization by local anasthesia
干预措施: UAE (Procedure)
结局指标
主要结局
evaluation use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire
时间窗: through study completion ,an average of 1 year
evaluation use of Dienogest versus uterine arteries embolization in improvement of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire
次要结局
未报告次要终点