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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Pain; Chronic Pelvic Pain Syndrome; Pelvic Pain Syndrome; Pelvic Congestive Syndrome; Pelvic Varices
• Intervention / Treatment: Diagnostic test: Transcatheter Venography; Procedure: Bilateral ovarian vein embolization

Detailed Description

The study is a randomized research trial of bilateral ovarian vein embolization (OVE) and pelvic vein embolization (PVE) in women with chronic pelvic pain (CPP), dilated and incompetent ovarian veins ≥6mm and pelvic varices (≥1 veins, >5 mm diameter) to assess for change in pain. Pain will be assessed by visual analog scale (VAS) and other relevant, validated quality of life metrics including the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 - Pain Intensity, Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health, Patient Global Impression of Change (PGIC) and EuroQol five-dimension (EQ 5D). The target population includes women age greater than or equal to 18 years who are pre-menopausal and have symptoms, and clinical and imaging findings corresponding to Pelvic Venous Disease (PeVD). Subjects will be randomized in a 1:1 fashion to embolization (treatment group) or venography only (control group). Follow-up will be assessed weekly and at 1, and 3 months and 6 months post procedure to assess for changes in quality of life in patients who receive ovarian/pelvic vein embolization versus no embolization.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronald S Winokur, MD; Phone Number: 646-962-9179; Email: rsw9004@med.cornell.edu
• Study Contact Backup: Name: Jincy Koshy, MHA; Phone Number: 646-962-2964; Email: jlk4004@med.cornell.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
      • Principal Investigator: Ramona Gupta, MD
      • Sub-Investigator: Kush Desai, MD
  • New York
    • New York, New York, United States, 10024
      • Weill Cornell Medicine
      • Principal Investigator: Ronald S Winokur, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina (UNC)
      • Principal Investigator: Gloria Salazar, MD
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular
      • Principal Investigator: Kathleen Gibson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7) 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
• Symptoms-Varices-Pathophysiology Classification: S2V2PBGV,R,NT, S2V2PRGV,R,NT, S2V2PLGV,R,NT
• Left or right ovarian vein diameter greater than or equal to 6 mm
• Presence of pelvic varices as documented by transabdominal ultrasound or CT (≥1 veins, >5 mm diameter)

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
• 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
• Significant iliac vein stenosis defined as >61% area reduction as determined by the investigator at the time on pelvic DUS or CT venogram prior to study procedure
• Significant renal vein stenosis with resultant hilar varices and lumbar collaterals as determined by the investigator at the time of venography
• Serious medical condition 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Transcatheter Venography	Diagnostic test: Transcatheter Venography; Venographic assessment of ovarian veins and internal iliac veins; Other Names: Diagnostic Venography
Experimental: Bilateral Ovarian Vein Embolization; Transcatheter Venography plus Bilateral Ovarian Vein Embolization.	Diagnostic test: Transcatheter Venography; Venographic assessment of ovarian veins and internal iliac veins; Other Names: Diagnostic Venography; Procedure: Bilateral ovarian vein embolization; Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.; Other Names: Ovarian vein and pelvic vein embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS) for pelvic pain	The VAS pain score is a standard scale from 0 to 10, defining 0 as ''no pain'' and 10 ''worst pain possible.''	Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale	The Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale assess how much a person hurts. The scale ranges from 1-5, defining 1 as ''no pain'' and 5 ''very severe pain.''	Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale	The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measures assess an individual's physical, mental, and social health. The scale scores from from 5 to 1 with 5 = "Excellent" and 1= "Poor ".	Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
Change in Patient Global Impression of Change (PGIC)	The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale with 1= "Very Much Improved" and 7= "Very Much Worse".	30, 90 and 180 day follow up
Change in EuroQol five-dimension (EQ-5D) scale	The EuroQol five-dimension (EQ-5D) is a concise, generic measure of self-reported health at each visit. Patients will tick the one box that best describes their health on that day. This scale will measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The scale is numbered from 0 to 100. =100 means the best health the patient can imagine and 0 means the worst health the patient can imagine,.	Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Penumbra Inc.; Society of Interventional Radiology Foundation; VIVA Physicians
• Investigators: Principal Investigator: Ronald S Winokur, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Disease; Syndrome; Somatoform Disorders; Varicose Veins; Pelvic Pain
• Other Study ID Numbers: 23-08026405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes