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
- Phase
- Not Applicable
- Intervention
- Transcatheter Venography
- Conditions
- Chronic Pelvic Pain Syndrome
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Change in Visual Analog Scale (VAS) for pelvic pain
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
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)
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
Arms & Interventions
Transcatheter Venography
Intervention: Transcatheter Venography
Bilateral Ovarian Vein Embolization
Transcatheter Venography plus Bilateral Ovarian Vein Embolization.
Intervention: Transcatheter Venography
Bilateral Ovarian Vein Embolization
Transcatheter Venography plus Bilateral Ovarian Vein Embolization.
Intervention: Bilateral ovarian vein embolization
Outcomes
Primary Outcomes
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
The VAS pain score is a standard scale from 0 to 10, defining 0 as ''no pain'' and 10 ''worst pain possible.''
Secondary Outcomes
- Change in Patient Global Impression of Change (PGIC)(30, 90 and 180 day follow up)
- Change in EuroQol five-dimension (EQ-5D) scale(Weekly for 4 weeks prior to Day 1. Then at 30, 90 and 180 day follow up)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 3A Pain Intensity Scale(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(Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up)