PFI-TT: Initial proof of concept of a novel minimally invasive tool to address urethral narrowing

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The broader impact/commercial potential of this PFI project is to dramatically improve the quality of life for men with urethral stricture disease (USD), by enabling them to undergo a curative minimally invasive treatment. USD is a narrowing of the urinary tract (urethra), similar to a band of scar tissue, causing painful and frequent urination. Nearly 1% of men on Medicare seek treatment for USD, and over $300 million is spent annually on treatment in the United States alone. Current options for these patients are either minimally invasive procedures with high rates of recurrence, or complex open reconstructive surgery of the urethra - only performed by small number of experts. Many patients diagnosed with USD undergo repeat minimally invasive treatments - worsening their condition; their lives revolve around the next painful trip to the restroom. Our innovation will bridge the gap between these approaches, allowing general urologists to provide effective treatment by performing graft reconstruction of the urethra minimally invasively. This will make treatment accessible to patients who don?t have access to an expert surgeon, and to those who are ineligible for a long complex surgery.The proposed project will develop a prototype for the minimally invasive surgical tool which will be fully integrated. Research objectives include: the development of an anatomically correct urethral model, iterative manufacture and testing of device sub-components, and integration of sub-components into the complete device for functional testing in the urethral model. Sub-component testing will include measuring the forces exerted upon the graft used for reconstruction during various steps of the procedure, to ensure that the final integrated device design can successfully deliver a graft, and not cause damage to the graft upon device removal. Once sub-components have been tested and modified as needed, they will be integrated into the complete device for testing functionality in the urethral model. The resulting integrated prototype will be fully functional, and be ready for use in a future pilot study in an animal model (beyond PFI-TT).This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.