Glue Embolization Versus Conservative Treatment for Pelvic Congestion Syndrome: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Degree of pain
研究概览
简要总结
The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.
详细描述
Pelvic congestion syndrome (PCS) is a common cause of chronic lower abdominal/pelvic pain, estimated to affect about 40 % of women, predominantly between the ages of 30 and 45.The treatment of PCS depends mainly on the severity of the pain. Non-steroid anti-inflammatory drugs are often used, and contraceptives have a role in cases of pain associated predominantly with menstruation.
Traditionally, conservative approaches, such as pharmacotherapy with venoactive drugs like micronized purified flavonoid fraction (Daflon), have been utilized to address the symptoms of PCS. Daflon has been used to treat venous insufficiency and has demonstrated efficacy in reducing symptoms and improving the quality of life in patients with PCS. Its mechanism of action includes improving venous tone, reducing venous stasis, and exerting anti-inflammatory effects. Endovascular treatment of PCS is challenging and requires occlusion of incompetent pelvic veins.
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
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged from 30 to 50 years.
- •Complaining from pelvic congestion syndrome.
排除标准
- •Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.
- •Patients who are treated with opiates to reduce pelvic pain in the period before the study.
- •Patient with history of contrast allergy
- •Patient with renal impairment
- •Patient has alternative gynecological cause of chronic pelvic pain as pelvic inflammatory disease (PID), endometriosis, fibroid, adenomyosis, ovarian cyst
- •Patient underwent any previous intervention for pelvic congestion syndrome as laparoscopy or surgery.
研究组 & 干预措施
Micronized purified flavonoid fraction (Daflon ®)
Patients will receive micronized purified flavonoid fraction (Daflon ®), 500 mg twice/daily for 3 months.
干预措施: Micronized purified flavonoid fraction (Daflon ®) (Drug)
Glue embolization
Patients will receive transcatheter glue embolization.
干预措施: Glue embolization (Other)
结局指标
主要结局
Degree of pain
时间窗: Post intervention for 3 months
Degree of pain will be assessed using a Visual Analog Scale (VAS). The VAS is a self-reported scale consisting of a horizontal or vertical line, usually 10 cm long. An introductory question asks the patient to mark a point on the line that best refers to his or her pain. Patients will be encouraged to assess the intensity of subjective manifestation of each symptom by scoring from 0 (no symptom) to 10 (the most extreme manifestation possible).
次要结局
- Incidence of recurrence of pain(Post intervention for 3 months)
- Pelvic Venous Clinical Severity Score (PVCSS)(Post intervention for 3 months)
研究者
Mohamed Ibrahim Adel Eleissawy
Lecturer of Vascular and Endovascular Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University