Ulipristal Acetate Therapy Versus Uterine Artery Embolization in Management of Uterine Fibroids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Decline in dominant fibroid volume (in cubic centimeters).
研究概览
简要总结
Study objective: To prove that Ulipristal acetate is an effective line of management for uterine fibroids by causing a significant decline in fibroid volumes resulting in a substantial relief of fibroid-related symptoms, and to compare its results with those of uterine artery embolization.
Design: A randomized control trial. Setting: Maternity Hospital, Ain Shams University.
Patients: Women with symptomatic uterine fibroids.
Interventions: 70 women were randomly assigned to either Ulipristal Acetate (UA) group or uterine artery embolization (UAE) group (35 in each group). Both groups were followed up to detect the decline in fibroid size as well as the improvement of symptoms.
详细描述
Inclusion Criteria:
Women with symptomatic uterine fibroids were recruited into the study after fulfilling the following criteria:
- Their age should range from 35 to 50 years.
- Their body mass index (BMI) should range from 18 to 35 Kg/m2.
- The presence of multiple symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification.
- The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound.
- They should not be seeking future fertility.
- They should be refusing any surgical intervention whether myomectomy or hysterectomy.
Exclusion Criteria:
- Post-menopausal status or premature ovarian failure.
- Type 0, 1 and 7 uterine fibroids according to FIGO classification.
- Previous myomectomy or any uterine surgery.
- Previous or ongoing hormonal treatment.
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
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Their age should range from 35 to 50 years.
- •Their body mass index (BMI) should range from 18 to 35 Kg/m
- •The presence of one or more symptomatic type 2, 3, 4, 5, or 6 uterine fibroids according to the FIGO classification.
- •The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound.
- •They should not be seeking future fertility.
- •They should be refusing any surgical intervention whether myomectomy or hysterectomy.
排除标准
- •Post-menopausal status or premature ovarian failure.
- •Type 0, 1 and 7 uterine fibroids according to FIGO classification.
- •Previous myomectomy or any uterine surgery.
- •Previous or ongoing hormonal treatment.
研究组 & 干预措施
Group A "Ulipristal Acetate (UA) - Fibristal group" (n=35)
Patients within this group received oral Ulipristal Acetate (Fibristal ©) 5 mg / day starting from the first day of menstrual bleeding, and for 3 months (period of the study).
干预措施: Ulipristal Oral Tablet (Drug)
Group B "Uterine artery embolization (UAE) group" (n=35)
Patients within this group underwent bilateral selective uterine artery embolization, during which polyvinyl alcohol (PVA) particles was administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected. The gelatin sponge cap was thought to both complete the occlusion of the uterine artery and to prevent PVA particles from being drawn out of the uterine artery by the Venturi effect, which would result in non-target embolization.
干预措施: Uterine artery embolization (Procedure)
结局指标
主要结局
Decline in dominant fibroid volume (in cubic centimeters).
时间窗: 3 months
measured by transvaginal ultrasound.
次要结局
- Relief of abnormal uterine bleeding.(3 months)
- Relief of pelvic pain.(3 months)
- Relief of pelvic pressure symptoms.(3 months)
- Adverse effects.(6 months)
研究者
Paula Naseef
Principal Investigator
Ain Shams Maternity Hospital