Objective-To assess the functionality, occlusive efficiency and biocompatibility of a novel artificial urinary sphincter, the Tape Mechanical Occlusive Device (TMOD), [GT Urological, Minneapolis, MN], following implantation in a live canine model as well as its occlusive efficiency and sizing parameters in human cadavers.Materials and Methods-Three female canines underwent implantation of the device at the level of the bladder neck. Functionality was assessed starting at two weeks post-implantation up to 9 weeks. The devices were activated at 2 weeks, then deactivated for three, thirty minute sessions per day to permit voiding. Urethral occlusion pressures (UOP) and biocompatibility for systemic toxicity and local tissue response were examined. Additionally, the TMOD was inserted in 3 male cadavers to determine sizing parameters and to assess UOP utilizing pressure profilometry.Results-In the canine model, UOP increased from a range of 9-42 cm H 2 O with TMOD deactivated to a range of 57-82 cm H 2 O with the TMOD activated. Pathological examination revealed unremarkable pseudo-capsular tissues surrounding the device. No histological or structural evidence of systemic toxicity was observed. Sizing parameters similar to other urological implants were confirmed in the male cadavers and urethral occlusion pressures increased from 24-30 cm H 2 O with the device deactivated to 61-105 cm H 2 O with the device activated.
Conclusion-The TMOD meets the current standards for an artificial urinary sphincter in terms of functionality, biocompatibility and achieving desired occlusion pressures following chronic implantation. Additional testing in male canines followed by early human clinical trials is being contemplated.