A Randomized Trial of Endovascular Embolization Treatment in Pelvic Congestion Syndrome: Fibered Platinum Coils versus Vascular Plugs with 1-Year Clinical Outcomes.

PURPOSE: To compare safety and efficacy of vascular plugs (VPs) and fibered platinum coils (FPCs) for embolization in pelvic congestion syndrome (PCS). MATERIALS AND METHODS: A randomized, prospective, single-center study enrolled 100 women with PCS from January 2014 to January 2015. Patients were randomly assigned to 2 groups, and embolization was performed with FPCs (n = 50) or VPs (n = 50). Mean age of patients was 42.7 years ± 7.60, and mean visual analog scale (VAS) score for pelvic pain before treatment was 7.4 ± 7.60. Primary outcome (clinical success at 1 y using a VAS), number of devices, procedure and fluoroscopy times, radiation doses, costs, and complications were compared, and participants were followed at 1, 3, 6, and 12 months. RESULTS: Clinical success and subjective improvement were not significantly different at 1-year follow-up (89.7% for FPCs vs 90.6% for VPs; P = .760). Mean number of devices per case was 18.2 ± 1.33 for FPCs and 4.1 ± 0.31 for VPs (P < .001). Three FPCs and 1 VP migrated to pulmonary vasculature approximately 3-6 months after the embolization procedure; all were retrieved without complications. The FPC group had a significantly longer fluoroscopy time (33.4 min ± 4.68 vs 19.5 min ± 6.14) and larger radiation dose (air kerma 948.0 mGy ± 248.45 vs 320.7 mGy ± 134.33) (all P < .001). CONCLUSIONS: Embolization for PCS resulted in pain relief in 90% of patients; clinical success was not affected by embolic device. VPs were associated with decreased fluoroscopy time and radiation dose.