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Recruiting NCT06168058

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

No phase Interventional Chronic Pelvic Pain Syndrome Pelvic Pain Pelvic Varices Pelvic Congestive Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter Venography, Bilateral ovarian vein embolization.
Who it may be relevant to
Registry conditions: Chronic Pelvic Pain Syndrome, Pelvic Pain, Pelvic Varices, Pelvic Congestive Syndrome. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test Transcatheter Venography
    Venographic assessment of ovarian veins and internal iliac veins
  • Procedure Bilateral ovarian vein embolization
    Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.

Primary outcome measures

  • Change in Visual Analog Scale (VAS) for pelvic pain [Time frame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up]
Secondary outcome measures (4)
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale [Time frame: 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 [Time frame: 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) [Time frame: 30, 90 and 180 day follow up]
  • Change in EuroQol five-dimension (EQ-5D) scale [Time frame: Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up]

Eligibility criteria

Inclusion criteria

  • 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
  • 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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Northwell Health Physician Partners Vascular Surgery — New Hyde Park
  • Weill Cornell Medicine — New York
  • UNC School of Medicine — Chapel Hill
  • Lake Washington Vascular — Bellevue

Identifiers

NCT: NCT06168058 · 23-08026405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗