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临床试验/NCT05050357
NCT05050357已完成不适用

Effectiveness of Hormonal Intrauterine Device in Treating Pelvic Congestion Syndrome Compared to Oral Progestin

Assiut University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
The effectiveness of hormonal IUD in reducing pain in patient with pelvic congestion syndrome in comparison to oral progestin

研究概览

简要总结

The aim of this study is to compare the effectiveness of hormonal intrauterine device (IUD) in treatment of pelvic congestion syndrome in comparison with oral progestins treatment.

详细描述

Pelvic congestion syndrome (PCS) is a poorly understood association between varicose or dilated pelvic veins and chronic pelvic pain (CPP). It is also called Pelvic venous syndrome, Pelvic venous insufficiency, Pelvic varices and Pelvic vascular dysfunction Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related to the pelvis of either men or women for more than 6 months according to The International Association for the Study of Pain (IASP). In other words, chronic pelvic pain with associated ovarian vein varicosities is termed pelvic congestion syndrome (PCS) and is an important but under-diagnosed condition.

Millions of women worldwide\e may suffer with chronic pelvic pain at some time in their life, and the occurrence may be as high as 39.1%. Chronic pelvic pain may account for 10 to 15% of outpatient gynecologic visits in the United States.The typical age of patients with this condition ranges from 20 to 45 years. It is unclear whether there is any genetic or ethnic predilection.

The etiology of pelvic congestion syndrome is reflux of blood in the ovarian veins due to the absence of functioning valves, resulting in retrograde blood flow and eventual venous dilatation. The cardinal presenting symptom of PCS is pelvic pain, usually described as a dull ache, without evidence of inflammatory disease. Clinical signs may include vulvar varicosities extending onto the medial thigh and long saphenous territory as well as tenderness on deep palpation at the ovarian point; however, such signs are not always present.

For many women with PCS, the road toward a definitive diagnosis has been long and laborious. Certainly the diagnosis of PCS continues to challenge all physicians involved. However, a heightened awareness and clinical suspicion for the specific symptomatology and associated findings may bring about a more rapid progression to the much anticipated treatment. Pelvic ultrasound (US) and/or computed tomography (CT) scan are usually the first imaging modalities in the evaluation of patients with chronic pelvic pain. Both provide excellent resolution of the uterus. Although a CT scan has greater sensitivity for showing varicosities throughout the lower pelvis, Two dimensional ultrasound with Doppler examination provides dynamic information about visualized venous blood flow.

Laparoscopy is often used in patients with chronic pelvic pain in search of a specific diagnosis. This direct visualization is excellent for ruling out other etiologies distinct from PCS such as endometriosis. However, because the examination is done supine and requires insufflation of CO2 gas, there may be compression of varices if present, thereby masking the diagnosis of PCS.Certainly, the diagnostic venogram continues to provide physicians with a reliable minimally invasive gold standard tool in patients with PCS.The diagnostic venogram gives immediate dynamic flow information and measurements of ovarian and pelvic veins with the option of changing patient position.

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 (Care Provider)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients with clinical symptoms of pelvic congestion syndrome documented by Trans abdominal and/or transvaginal Doppler ultrasound (dilated ovarian veins with reversed caudal flow, presence of varices , dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary and variable duplex waveform during the Valsalva's maneuver).

排除标准

  • Endometriosis.
  • Uterine fibroids.
  • Previous pelvic operations.
  • Urological diseases.
  • Patient seeking pregnancy
  • Pelvic inflammatory diseases
  • Congenital uterine malformations

研究组 & 干预措施

hormonal intrauterine device arm

Active Comparator

干预措施: Hormonal intrauterine device (Device)

progestin arm

Active Comparator

干预措施: Progestins Norethindrone (Drug)

结局指标

主要结局

The effectiveness of hormonal IUD in reducing pain in patient with pelvic congestion syndrome in comparison to oral progestin

时间窗: two years

The primary outcome measure is to compare the degree of pain reduction according to pain scale ( where the maximum for the scale will be 10 and means severe pain). The minimum of the score will be one and mean very mild pain to no pain ) in pelvic congestion syndrome cases taking hormonal IUD in comparison to those taking oral progestin.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelhamid Mohamed Abdelrahim AboDooh

Principal Investigator

Assiut University

研究点 (1)

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