Randomized Trial Comparing Ovarian and Pelvic Vein Embolization to Venography Alone for Women With Chronic Pelvic Pain and Pelvic Varices

What this Trial Is About

This research investigates the effects of ovarian vein and pelvic vein embolization compared to venography alone in women with chronic pelvic pain and pelvic varicose veins. It aims to determine how these procedures impact pain and quality of life, focusing on women who are pre-menopausal, aged 18 to 75, with symptoms and imaging findings consistent with Pelvic Venous Disease. The study uses a randomized controlled design with a single-blinded, parallel-group format. Participants are randomly assigned to one of two groups one undergoing bilateral ovarian vein embolization and pelvic vein embolization, and the other receiving only venographic assessment without embolization. The embolization procedure involves sclerosis of pelvic varices and coil embolization of both ovarian veins. Follow-up visits occur weekly and at 1, 3, and 6 months after the procedure to monitor outcomes. During the study, participants regularly assess their pain using tools such as the Visual Analog Scale VAS and several validated quality of life questionnaires including PROMIS Pain Intensity, Patient Global Impression of Change, and the EuroQol five-dimension scale. Researchers measure changes in pain and quality of life before treatment and throughout follow-up. The study also monitors safety and overall health during the six-month period following intervention or venography.

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