About this trial
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.
Eligibility criteria
Qualifiers
• 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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- embolization therapy
Treatment groups
Locations
Sponsors and collaborators
Mark Magdy Zekry
Lead sponsor
Assiut University
Sponsor institution