Clinical trial NCT06168058: Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Pelvic Pain
Pelvic Varices
Pelvic Congestive Syndrome
Pelvic Pain Syndrome
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Society of Interventional Radiology Foundation
name: VIVA Physicians
name: Penumbra Inc.
First posted: 2023-12-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Presence of venous origin chronic pelvic pain for greater than 6 months 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

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) for pelvic pain
timeFrame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
Secondary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale
timeFrame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale
timeFrame: Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up
measure: Change in Patient Global Impression of Change (PGIC)
timeFrame: 30, 90 and 180 day follow up
measure: Change in EuroQol five-dimension (EQ-5D) scale
timeFrame: Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC)
state: North Carolina
city: Bellevue
country: United States
facility: Lake Washington Vascular
state: Washington
Study officials:
affiliation: Weill Medical College of Cornell University
name: Ronald S Winokur, MD
role: PRINCIPAL_INVESTIGATOR
References: