Sham procedure
The sham control was the insertion and removal of an 18F silicon Foley catheter to simulate both the implantation and retrieval procedures. Throughout the procedure, the surgeon gave verbal description as if deploying the iTind device, after which the catheter was removed. A similar protocol was followed for the sham device retrieval. Although the iTind device is deployed through a rigid cystoscope, a Foley catheter was used to minimize the risk of procedure-related morbidity as suggested by the FDA. Subjects in both the device and control groups were draped to prevent them from seeing the treating physician and the device.