Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Dec 4, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a procedure called ovarian vein and pelvic vein embolization can help women suffering from chronic pelvic pain and pelvic varicose veins. The study aims to compare the effects of this treatment with a different approach that does not involve the embolization. Researchers want to determine how these two methods impact the quality of life for women experiencing these conditions.

To be eligible for the trial, participants need to be women aged 18 and older who have had pelvic pain for more than six months, which gets worse with physical activity but improves when lying down. They must also have certain types of pelvic varices, or enlarged veins, confirmed by imaging tests. If you are interested in participating, you should know that the trial is not yet recruiting, and there are specific health conditions and situations that may prevent someone from joining, such as pregnancy, serious medical issues, or previous treatments for pelvic veins. If chosen, participants can expect to undergo evaluations and possibly receive the embolization treatment, with follow-up to assess how their pain and quality of life change.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 1. Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7 as determined by 4 consecutive weeks of baseline self-assessments) despite non-vascular therapy as delineated by the following criteria:
• • Pain exacerbated by walking, standing or lifting
• • Symptoms are at least partially alleviated by lying down
• • Prolonged post-coital ache
• • Absence of non-venous origin CPP as determined by Gynecology examination
• 2. Symptoms-Varices-Pathophysiology Classification18 including of one of the following:
• • •S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT
• • 3. CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors
• • Left or right ovarian vein diameter greater than or equal to 6 mm as documented by TAUS or CT
• • Presence of intrabdominal/pelvic varices as documented by TAUS or CT (≥1 veins, \>5 mm diameter)
• • Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis
• Exclusion Criteria:
• • Female \<18 years of age
• • Pregnancy (positive pregnancy test)
• • Female subject who plans to become pregnant during study period
• • Female subject who is actively breastfeeding
• • Patient who is post-menopausal or anovulatory with hormone suppression
• • History of prior hysterectomy
• • Prior ovarian vein embolization or ovarian vein ligation
• • Inability to tolerate endovascular procedure due to acute illness or general health
• • Planned simultaneous treatment with nerve blocks during the duration of the study
• • Laparoscopy or planned surgical intervention during the duration of the study
• • Known allergy to sclerosant, coil, stent or catheter components including nickel allergy
• • Any iliac vein stenosis determined identified by the investigator on pelvic DUS, CT venogram, and/or Catheter Venography and deemed significant for exclusion by study patient review committee.
• • Any renal vein stenosis with resultant renal hilar varices/collaterals and lumbar collaterals identified by the investigator on pelvic DUS, CT venogram, and/or Diagnostic Venography and deemed significant for exclusion by study patient review committee.
• • Presence of isolated extra-pelvic vulvar and/or lower extremity varices without intrabdominal pelvic varices. Primary S3 categorization study exclusion.
• • Serious medical conditions that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF, etc.)
• • Severe allergy to iodinated or gadolinium-based contrast refractory to steroid premedication
• • Severe renal impairment (on chronic dialysis or estimated GFR \<30 mL/min)
• • Hemoglobin \<8.0 g/dL, uncorrectable INR \>3.0 or platelet count \<75,000/microliter
• • Inability to provide informed consent or to comply with study assessments
• • Post thrombotic IVC, iliac or ovarian vein changes