Embolization of Ovarian Vein and Pelvic Venous Reservoir for Treatment of Secondary Pelvic Congestion Syndrome

Official title

Transcatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir for Treatment of Pelvic Congestion Syndrome Secondary to May-Thurner Syndrome.

Overview

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.

Detailed description

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.

Interventions

• Procedure embolization therapy
  Transcatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir

Primary outcome measures

• Change in pelvic pain severity using VAS pain score as scale [Time frame: 12 months]
• The primary outcome measure is designed to assess the significant reduction in pelvic pain severity [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• • 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 1. Borghi C, Dell'Atti L. Pelvic congestion syndrome: the current state of the literature. Arch Gynecol Obstet. 2016;293(2):291-301. doi:10.1007/s00404-015-3895-7. 2. Bałabuszek K, Toborek M, Pietura R. Comprehensive overview of the venous disorder known as pelvic congestion syndrome. Ann Med. 2022;54(1):22-36. doi:10.1080/07853890.2021.2014556. 3. Ignacio EA, Dua R, Sarin S, et al. Pelvic congest

Identifiers

NCT: NCT07472504 · Pelvic congestion Syndrome

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗