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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Females with secondary pelvic congestion syndrome due to May thurner syndrome | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| embolization therapy | Procedure | Transcatheter Embolization of Ovarian Vein and Pelvic Venous Reservoir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pelvic pain severity using VAS pain score as scale | 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 | 12 months |
| The primary outcome measure is designed to assess the significant reduction in pelvic pain severity | 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. | 12 months |
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Inclusion Criteria:
âą Adult females aged 18 -60 years.
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. BaĆabuszek 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 congestion syndrome: diagnosis and treatment. Semin Intervent Radiol. 2008;25(4):361-368. doi:10.1055/s-0028-1102998. 4. O'Brien MT, Gillespie DL. Diagnosis and treatment of the pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2015;3(1):96-106. doi:10.1016/j.jvsv.2014.05.007. 5. Lakhanpal G, Kennedy R, Lakhanpal S, Sulakvelidze L, Pappas PJ. Pelvic venous insufficiency secondary to iliac vein stenosis and ovarian vein reflux treated with iliac vein stenting alone. J Vasc Surg Venous Lymphat Disord. 2021;9(5):1193-1198. doi:10.1016/j.jvsv.2021.03.006 6. Gavrilov SG, Vasilyev AV, Krasavin GV, Moskalenko YP, Mishakina NY. Endovascular interventions in the treatment of pelvic congestion syndrome caused by May-Thurner syndrome. J Vasc Surg Venous Lymphat Disord. 2020;8(6):1049-1057. doi:10.1016/j.jvsv.2020.02.01 7. Daugherty SF. Nonthrombotic Venous Obstructions Cause Pelvic Congestion Syndrome. J Vasc Surg Venous Lymphat Disord. 2015;3(1):117-118. doi:10.1016/j.jvsv.2014.10.008 |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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