Artificial Urethral Sphincter for Control of Urinary Incontinence in Pediatric Patients

PROJECT SUMMARY SignificanceEach year in the U Sbetweenandchildren are born with spina bifidaand nearly all of these patients develop neurogenic bladderUrinary incontinence in neurogenic bladder patients often is a result of inadequate bladder outletsphincter resistance and can lead to a significant negative impact on these patientsquality of lifeincluding emotional distress and other health issues related to the urinary leakageAt present there is no idealnon invasive method for urinary drainage and continence in childrenThere is a need for a device that more effectively addresses urinary incontinence in pediatric patients with neurogenic bladderInnovationThe SecUrine device is a soft silicone urinary valve that prevents urinary incontinence at the bladder outlet level that can be used in adults and childrenThis temporarynon surgical artificial urinary sphincter is deployed in the urethra at the bladder neck via urethral catheterization and removed afterdays with the use of a balloon urethral catheterThe valve allows for the passage of a catheter into the bladder via the urethra which allows for CIC to drain the bladderAdditionallythe 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 damageTo prevent encrustation of the devicea silicone material impregnated with an anti fouling agent is used to improve device longevity and reduce infection riskApproachIn this SBIR Phase I projectFannin Innovation Studio will optimize the prototype device design and test it in benchtop and animal models of the urinary tractThe Specific Aims of this project areDevelop the design and manufacturing methodand conduct in vitro feasibility tests for the SecUrine artificial urinary sphincter by exploring multiple concepts and implantable polymer candidatesThis includes refining product requirements for implant and delivery and removal systemevaluating implantable polymer elastomer candidates for urinary valvesideation and design of delivery and retrieval devicesand screening of material samples for antimicrobial efficacyConduct functional testing of the SecUrine device in a benchtop model and an acute porcine modelThis includes in vitro test bed developmentbench testing and final design selectionfabrication of final designs for animal testingand the in vivo testing of device insertioncatheterization voidingand device removal in a pig modelThe outcome of Phase I will be a fully functional prototype for an implantable valve that prevents urinary leakage and maintains safe bladder pressuresThe 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 PROJECT NARRATIVE Urinary incontinence is a major problem in pediatric patients with neurogenic bladderThe current standard of care is a combination of oxybutynina drug that reduces bladder muscle overactivityand intermittent catheterization approximatelytimes a dayHoweververy oftenthere is still leakage of urine between catheterizations which leads to significant emotional distress and other health related issuesIn the proposed solutiona soft silicone valve is insertednon invasivelyeverydaysinto the bladder neck to prevent urine leakageThe patient may still use intermittent catheterization as a method of voidingbut there will be no leakage between voids