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

Recruitment & Eligibility

Status: Not yet recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS) for pelvic pain

Secondary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale;Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Pain Intensity Scale;Change in Patient Global Impression of Change (PGIC);Change in EuroQol five-dimension (EQ-5D) scale