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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Diagnostic Test: Transcatheter Venography
* Procedure: Bilateral ovarian vein embolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |