embolization therapy
ProcedureTranscatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir
NCT Number: NCT07472504
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.
Trial opening soon.
Get Notified18 year–50 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transcatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir
Time frame: 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
Time frame: 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.
Mark Magdy Zekry
Other
Transcatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir for Treatment of Pelvic Congestion Syndrome Secondary to May-Thurner Syndrome.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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