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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMark Magdy Zekry

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

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Mark Magdy Zekry

Lead sponsor

Assiut University

Sponsor institution