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

RecruitingNA

Sponsor: Weill Medical College of Cornell University

Conditions: Chronic Pelvic Pain Syndrome, Pelvic Pain, Pelvic Varices, Pelvic Congestive Syndrome, Pelvic Pain Syndrome

Interventions: Transcatheter Venography, Bilateral ovarian vein embolization

Countries: United States

The purpose of this study is to see if a randomized controlled trial of ovarian vein and pelvic vein embolization versus venography alone could determine outcomes for women with chronic pelvic pain and pelvic varicose veins. The data gathered will assist in addressing changes in quality of life in patients who have ovarian/pelvic vein embolization versus no embolization.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (4)

New Hyde Park, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Bellevue, Washington, United States