RF Ablation of the Trigone for the Treatment of UUI

Up to 325 subjects who meet all inclusion and none of the exclusion criteria will be enrolled and up to 225 subjects will be randomized. Subjects will be randomized to either an active arm that includes treatment with the Hologic trigone RF ablation device, or a control arm who receive a sham procedure. With a 2:1 randomization, approximately 150 subjects will be treated with the Hologic trigone RF ablation device (treatment group) and 75 sham subjects treated with the sham procedure. Subjects will be blinded to their randomized treatment; however, due to the nature of the procedure, the treating investigator cannot be blinded to individual randomization assignments. Subjects who are randomized to the treatment arm will be followed at 2 weeks, 1 month, 3, 6, and 12 months and every 6 months thereafter. Subjects randomized to the sham arm will be followed through the 6-month visit. Follow up of all other subjects (cross-over and treatment arm) will conclude when the last subject in randomized treatment arm reaches their 12-month visit, is withdrawn, or is determined lost to follow-up.