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

NCT ID: NCT06168058

Last Updated: 2026-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-07
• Study Completion Date: 2027-06-30

Brief Summary

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transcatheter Venography

Group Type: SHAM_COMPARATOR

Transcatheter Venography

Intervention Type: DIAGNOSTIC_TEST

Venographic assessment of ovarian veins and internal iliac veins

Bilateral Ovarian Vein Embolization

Transcatheter Venography plus Bilateral Ovarian Vein Embolization.

Group Type: EXPERIMENTAL

Transcatheter Venography

Intervention Type: DIAGNOSTIC_TEST

Venographic assessment of ovarian veins and internal iliac veins

Bilateral ovarian vein embolization

Intervention Type: PROCEDURE

Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.

Interventions

Transcatheter Venography

Venographic assessment of ovarian veins and internal iliac veins

Intervention Type: DIAGNOSTIC_TEST

Bilateral ovarian vein embolization

Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.

Intervention Type: PROCEDURE

Other Intervention Names

Diagnostic Venography; Ovarian vein and pelvic vein embolization

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Interventional Radiology Foundation

OTHER

Sponsor Role: collaborator

VIVA Physicians

OTHER

Sponsor Role: collaborator

Penumbra Inc.

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald S Winokur, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

UNC School of Medicine

Chapel Hill, North Carolina, United States

Site Status: NOT_YET_RECRUITING

Lake Washington Vascular

Bellevue, Washington, United States

Site Status: WITHDRAWN

Countries

United States

Central Contacts

Ronald S Winokur, MD

Role: CONTACT

rsw9004@med.cornell.edu

646-962-9179

Sasha Garcia

Role: CONTACT

sag2958@med.cornell.edu

Other Identifiers

23-08026405

Identifier Type: -

Identifier Source: org_study_id