Ovarian and pelvic vein embolization for women with chronic pelvic pain and pelvic varices

Randomized Controlled, Single-Blinded, Parallel-Group Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices (EMBOLIZE) Trial

This trial tests whether embolizing ovarian and pelvic veins reduces chronic pelvic pain and improves quality of life in premenopausal women with pelvic varicose veins.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Weill Medical College of Cornell University (Academic / other)
• Locations: 3 sites (New York, New York and 2 other locations)
• Trial ID: NCT06168058 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled trial that assigns eligible premenopausal women 1:1 to bilateral ovarian and pelvic vein embolization versus diagnostic venography only. Eligible participants have at least six months of venous-origin pelvic pain with imaging evidence of dilated ovarian veins (≥6 mm) and pelvic varices (≥5 mm). Pain and quality of life are measured using VAS, PROMIS pain and global health scales, PGIC, and EQ-5D, with follow-up weekly and at 1, 3, and 6 months after the procedure. The trial is being run at multiple U.S. centers including Weill Cornell Medicine, UNC School of Medicine, and Lake Washington Vascular.

Who should consider this trial

Good fit: Premenopausal women age ≥18 with at least six months of venous-type chronic pelvic pain (baseline VAS ≥7) and imaging showing ovarian vein diameter ≥6 mm and pelvic varices ≥5 mm are the intended participants.

Not a fit: Women whose pain is not of venous origin, who are postmenopausal, who lack the specified vein dilation on imaging, or whose symptoms are due to other pelvic pathology are unlikely to benefit from embolization in this trial.

Why it matters

Potential benefit: If successful, the procedure could reduce chronic pelvic pain and improve quality of life for women whose pain is caused by pelvic venous insufficiency.

How similar studies have performed: Observational and nonrandomized studies have reported symptom improvement after ovarian/pelvic vein embolization, but high-quality randomized data are limited.

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

Where this trial is running

New York, New York and 2 other locations

• Weill Cornell Medicine — New York, New York, United States (Recruiting)
• UNC School of Medicine — Chapel Hill, North Carolina, United States (Recruiting)
• Lake Washington Vascular — Bellevue, Washington, United States (Withdrawn)

Study contacts

• Principal investigator: Ronald S Winokur, MD — Weill Medical College of Cornell University
• Study coordinator: Ronald S Winokur, MD

Conditions Chronic Pelvic Pain Syndrome; Pelvic Pain; Pelvic Varices; Pelvic Congestive Syndrome; Pelvic Pain Syndrome