Endovascular Versus Medical Treatment for the Pelvic Congestion Syndrome
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 主要终点
- visual analogue scale (VAS)
研究概览
简要总结
Compare the efficacy and safety of endovascular treatment with sandwich technique (controlled release coils and 2% polidocanol foam) associated with diosmin-hisperidine and ibuprofen medical treatment and only the best chronic medical treatment available diosmin-hisperidine and ibuprofen for 3 months, in women of active gynecological age carrying pelvic congestion syndrome in public assistance in Montevideo, Uruguay.
详细描述
Pelvic congestion syndrome (PCS) is a recognized and frequent cause of Chronic Pelvic Pain (10% to 30%). It is defined as the presence of chronic symptoms, which may include pelvic pain, perineal heaviness, urinary urgency and postcoital pain, caused by reflux and / or obstruction of the gonadic and / or pelvic veins, and that may be associated with vulvar, perineal and lower limbs varicose veins.
There is no standard approach to managing PCS. According to expert recommendations, therapies should be individualized according to the patient's symptoms and needs.
Medical treatment options include progestagens, danazol, combined oral hormonal contraceptives, phlebotonics such as hisperidine-added diosmin, non-steroidal anti-inflammatory drugs and gonadotropin-releasing hormone (GnRH) agonists
Currently, the only accepted chronic medical treatment is the association of non-steroidal and phlebotonic anti-inflammatories, but they have shown a poor symptomatic benefit in reducing pain.
Surgical treatment has evolved over time mainly in the hands of laparoscopic techniques, currently the endovascular option is the most widely accepted for presenting excellent long-term results with abolition of pain in up to 90% at 2 years.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Phlebography will be performed to both groups. On the experimental group, the treatment of the pelvic congestion will be performed, while the procedure will be stopped on the control group. Neither the patient or the reference gynecologist will be informed if the treatment took place.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Active gynecological age
- •Chronic pelvic pain diagnosed by gynecologist of at least 6 months of evolution.
- •Transvaginal duplex ultrasound: presence of periuterine varicose veins defined by veins larger than 5mm in diameter with reflux greater than 0.5 seconds on Valsava maneuvers.
排除标准
- •Presence of other causes of chronic pelvic pain: endometriosis, pelvic inflammatory disease, postoperative adhesions, uterine myoma, adenomyosis, ovarian tumors, polycystic ovary.
- •Fibromyalgia
- •BMI greater than 35
- •Chronic kidney disease
- •thrombophilia
- •Alterationof coagulation.
- •Allergy to iodinated contrast medium.
研究组 & 干预措施
Interventional treatment plus best chronic medical treatment
Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
干预措施: Medtronic® Concerto® detachable coil system (Device)
Interventional treatment plus best chronic medical treatment
Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
干预措施: sclerosis (Procedure)
Interventional treatment plus best chronic medical treatment
Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
干预措施: Diosmin / Hesperidin (Drug)
Interventional treatment plus best chronic medical treatment
Sandwich embolization ( 2% polidocanol + Coils) Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
干预措施: Ibuprofen 400 mg (Drug)
Best chronic medical treatment alone
Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
干预措施: Diosmin / Hesperidin (Drug)
Best chronic medical treatment alone
Diosmin hisperidin 1g twice a day for 6 months Ibuprofen 500mg 3 times a day for 6 months
干预措施: Ibuprofen 400 mg (Drug)
结局指标
主要结局
visual analogue scale (VAS)
时间窗: 3 months
Pain assessment 1-10 from no pain to severe
Lattinen index
时间窗: 3 months
chronic pain assessment 2-22 from low to high
McGill Pain Questionnaire
时间窗: 3 months
subjective pain experience assessment
次要结局
- Female sexual function index(3 months)
- varicose and reflux persistance by transabdominal duplex scan(3 months)
- varicose and reflux persistance by transvaginal duplex scan(3 months)
- varicose persistance assesment by tomography(3 months)
研究者
Eduardo Sebastian Sarutte Rosello, MD VS MSc
Vascular Surgery Asistant Professor
Hospital de Clínicas Dr. Manuel Quintela