Artificial Urethral Sphincter for Control of Urinary Incontinence in Pediatric Patients

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PROJECT SUMMARY Significance: Each year in the U.S., between 1,500 and 2,000 children are born with spina bifida, and nearly all of these patients develop neurogenic bladder. Urinary incontinence in neurogenic bladder patients often is a result of inadequate bladder outlet / sphincter resistance and can lead to a significant negative impact on these patients’ quality of life, including emotional distress and other health issues related to the urinary leakage. At present there is no ideal, non-invasive method for urinary drainage and continence in children. There is a need for a device that more effectively addresses urinary incontinence in pediatric patients with neurogenic bladder. Innovation: The SecUrine device is a soft silicone urinary valve that prevents urinary incontinence at the bladder outlet level that can be used in adults and children. This temporary, non-surgical artificial urinary sphincter is deployed in the urethra at the bladder neck via urethral catheterization and removed after 29 days with the use of a balloon urethral catheter. The valve allows for the passage of a catheter into the bladder via the urethra which allows for CIC to drain the bladder. Additionally, the valve will open when the pressure in the bladder reaches a threshold value serving as a safety mechanism that avoids high bladder pressures and subsequent kidney damage. To prevent encrustation of the device, a silicone material impregnated with an anti-fouling agent is used to improve device longevity and reduce infection risk. Approach: In this SBIR Phase I project, Fannin Innovation Studio will optimize the prototype device design and test it in benchtop and animal models of the urinary tract. The Specific Aims of this project are: (1) Develop the design and manufacturing method, and conduct in vitro feasibility tests for the SecUrine artificial urinary sphincter by exploring multiple concepts and implantable polymer candidates. This includes refining product requirements for implant and delivery and removal system, evaluating implantable polymer/elastomer candidates for urinary valves, ideation and design of delivery and retrieval devices, and screening of material samples for antimicrobial efficacy. (2) Conduct functional testing of the SecUrine device in a benchtop model and an acute porcine model. This includes in vitro test bed development, bench testing and final design selection, fabrication of final designs for animal testing, and the in vivo testing of device insertion, catheterization/voiding, and device removal in a pig model. The outcome of Phase I will be a fully functional prototype for an implantable valve that prevents urinary leakage and maintains safe bladder pressures. The SecUrine device provides a non-invasive solution to pediatric neurogenic bladder patients that is compatible with their urinary tract anatomy and allows them to avoid surgical procedures during their pediatric growth years.