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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Venographic assessment of ovarian veins and internal iliac veins
Intervention will include sclerosis of pelvic varices and coil embolization of the bilateral ovarian veins.
Weill Cornell Medicine
New York, New York, United States
RECRUITINGUNC School of Medicine
Chapel Hill, North Carolina, United States
NOT_YET_RECRUITINGLake Washington Vascular
Bellevue, Washington, United States
WITHDRAWNChange 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.''
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) 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.''
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
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 ".
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)
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".
Time frame: 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,.
Time frame: Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up
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