Transcatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir for Treatment of Pelvic Congestion Syndrome Secondary to May-Thurner Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in pelvic pain severity using VAS pain score as scale
研究概览
简要总结
Transcatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir for Treatment of Pelvic Congestion Syndrome Secondary to May-Thurner Syndrome.
This study aims to prospectively evaluate the short-term clinical outcomes and the incidence of post-embolization stenting for residual symptoms.
详细描述
Pelvic congestion syndrome (PCS) is characterized by chronic non- cyclical pelvic pain lasting for more than six months. While ovarian vein reflux is a well-known cause, venous outflow obstruction such as left common iliac vein compression (May-thurner syndrome) has gained recognition as a significant cause for PCS (secondary PCS) This obstruction causes increased venous pressure in the pelvic plexus, leading to vein wall remodelling, valvular incompetence, and the formation of tortuous, refluxing pelvic veins. Patients may experience chronic, dull pelvic pain, worsened by standing, perineal heaviness, dyspareunia, urinary urgency, postcoital pain, and vulvar or superficial non-saphenous veins varicosities. Ovarian veins and pelvic venous reservoir embolization can be performed through mechanical occlusion by coils, plugs, or liquid sclerosing agents, which promote vessel sclerosis, resulting in permanent occlusion at points of pelvic venous reflux.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Adult females aged 18 -60 years.
- •Clinical symptoms consistent with PCS >6 months refractory to conservative treatment(e.g., chronic pelvic pain (CPP) of at least 6 months duration, unresponsive to conventional pain management strategies and worsening with standing, dyspareunia, pelvic heaviness, presence of vulvar/perineal/thigh varices and ovarian point tenderness during examination in patients with history of post-coital pain).
- •Symptom Correlation: Pelvic pain is deemed to be significantly attributable to the identified iliac venous compression after multidisciplinary assessment for exclusion of the other causes of chronic pelvic pain (e.g., gynaecologist, urologist, pain specialist).
- •Imaging-confirmed non-thrombotic iliac venous outflow stenosis or occlusion with ovarian and/or pelvic venous reservoir reflux (e.g., cross-sectional area reduction on direct CT venography, MR venography or digital subtraction angiography)
- •Informed Consent: Willingness and ability to provide written informed consent prior to study-specific procedures.
- •Adherence to Follow-up: Willingness and ability to comply with scheduled follow-up visits and study procedures.
排除标准
- •Primary Pelvic Congestion Syndrome (PCS) only: Patients with significant pelvic venous reflux (e.g., ovarian or internal iliac vein reflux) without demonstrable and significant iliac venous outflow obstruction (i.e., primary PCS without secondary component).
- •Pelvic Congestion Syndrome secondary to Nutcracker syndrome.
- •Acute Deep Vein Thrombosis (DVT) on the affected side or known uncontrolled hypercoagulable states.
- •Contraindications to Anticoagulation: Known severe coagulopathy or absolute contraindications to the required antiplatelet and/or anticoagulant therapy post-stenting.
- •Pregnancy.
- •Severe Systemic Illness: Patients with severe, uncontrolled systemic diseases (e.g., severe renal failure, uncontrolled heart failure, uncontrolled hypertension, severe liver dysfunction) that would preclude safe participation in an invasive procedure or confound symptom assessment.
- •Active Infection: Any active systemic or localized infection, particularly at the access site.
- •Malignancy: Known active malignancy, especially pelvic malignancy, which could be the primary cause of pelvic pain or venous compression.
- •Other Dominant Causes of Pelvic Pain: Clear evidence of other treatable and dominant causes of chronic pelvic pain (e.g., severe endometriosis, adenomyosis, large uterine fibroids, severe interstitial cystitis, inflammatory bowel disease) that have not been adequately addressed or where these conditions are considered the primary source of pain.
- •Known Allergy: Documented severe allergy to contrast media or any components of the embolizing materials that cannot be managed.
- •Inability to Consent or Cooperate: Patients with cognitive impairment, psychological instability, or uncooperative behavior that would prevent informed consent or adherence to study procedures and follow-up.
研究组 & 干预措施
Adult Females with secondary pelvic congestion syndrome due to May thurner syndrome
干预措施: embolization therapy (Procedure)
结局指标
主要结局
Change in pelvic pain severity using VAS pain score as scale
时间窗: 12 months
The primary outcome measure is designed to assess the significant reduction in pelvic pain severity which is defined as a ≥ 50% reduction in the VAS pain score from baseline to post-procedure at 1, 3, 6, 9 and 12 months post-procedure. Alternatively, a patient-reported VAS score of ≤ 3 at the same intervals post-procedure may also be considered a successful outcome, representing mild or no pain Improvement in Specific PCS Symptoms: Assessment of individual PCS symptoms (e.g., dyspareunia, dysmenorrhea, post-coital pain, pelvic heaviness, lower extremity pain/edema) using validated symptom scales such as Pelvic Venous Clinical Severity Score (PVCSS) (e.g., categorical improvement: complete resolution, significant improvement, mild improvement, no change, worsening
The primary outcome measure is designed to assess the significant reduction in pelvic pain severity
时间窗: 12 months
The primary outcome measure is designed to assess the significant reduction in pelvic pain severity which is defined as a ≥ 50% reduction in the VAS pain score from baseline to post-procedure at 1, 3, 6, 9 and 12 months post-procedure. Alternatively, a patient-reported VAS score of ≤ 3 at the same intervals post-procedure may also be considered a successful outcome, representing mild or no pain.
次要结局
未报告次要终点
研究者
Mark Magdy Zekry
Vascular and endovascular Surgery Resident
Assiut University