Validation of Advanced Urinary Prosthesis for Improved Urologic Management and Outcomes of Urinary Retention Disorders

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PROJECT SUMMARY/ABSTRACT The primary objectives of this SBIR Phase II project are to evaluate the safety, effectiveness, and user satisfaction of the Connected Catheter System (CC). Spinal Singularity developed the CC as a fully internal, wirelessly controlled urinary prosthesis designed to dramatically improve quality of life for males with urinary retention disorders and to ultimately lower the incidence of catheter-associated medical complications such as urinary tract infections (UTIs) and genito-urinary trauma. The CC resides fully internally to the male lower urinary tract (LUT), with its distal end in the mid-penile urethra, for an extended service life of up to 29 days. The distal Catheter tip incorporates a magnetic valve-pump that enables the bladder to fill naturally and the user to control voiding using a hand-held wireless controller. By residing fully within the body and enabling users to empty their bladders comfortably and conveniently without frequent catheterization or external drainage apparatus, the CC holds the potential both to significantly improve urologic quality of life for its users and to reduce the rates and medical expenses of associated clinical complications, including UTI and trauma. Furthermore, the CC may significantly reduce the ongoing cost of supplies compared to clean intermittent catheterization. In this Phase II project, the CC system will first undergo a battery of preclinical design verification and validation testing. Then the CC will be used in up to 30 users in a clinical study designed to examine feasibility and safety. This single-arm study features three months of monitoring of CC use and will establish the clinical safety and feasibility of the CC. We expect that the CC will be easy to use and will improve user satisfaction scores in quality of life and the CC user survey. This project will provide some of the data necessary to support the subsequent regulatory submission of the CC for market clearance in the US and lay the groundwork for a more extensive clinical trial in a Phase IIb. The end goal is to make this superior bladder management technology available to millions of men who rely on urinary catheterization.