Non-surgical treatment option for pelvic organ prolapse

Project SummaryAbstract Reia is working to address a prevalent gynecological conditionpelvic organ prolapsePOPwhich affects more thanof women over the age ofPOP occurs when the pelvic floor connective tissue and muscles weakenallowing the uterus or vaginal walls to descendIn extreme casesthe uterus descends through the opening of the vagina and hangs outside of the bodyPOP can be treated non surgically with a medical device called a pessary which is inserted into the vaginal canal and acts as a shelf to support the descending organsCommonly used pessaries have a fixed and rigid designmaking them difficult or impossible for patients to remove and insert independentlyReia has done preliminary work with affected women and their practitioners to design an innovative collapsible pessary that will enable autonomous use and address many unmet needs of current pessaries on the marketThe purpose of this Phase I SBIR is to modify and optimize Reia s vaginal pessary design to further meet user and regulatory requirements and evaluate the technical feasibility of the designReia will achieve these aims by optimizing the actuation mechanism that allows for collapsibilitychanging the geometry to minimize irritationand enhancing cleanability to improve hygienicsReia will also examine safety and efficacy via simulations and benchtop testingDefined evaluation criteria have been established in order to measure progress and successReia s founding team is comprised of a urogynecologist withyears of experience fitting pessaries and treating POP and three female engineers with combined experience in Randamp Dproduct development and IP advisoryAdditionallyan advisory board contributes expertise in urogynecologybringing medical devices to marketand successful completion of numerous NIH grant funded projectsReia has strategically aligned with facilities in New Hampshire and Massachusetts to gain access to necessary equipment and resources to successfully complete this projectReia is committed to optimizing the pessary design to bring to market the first ever pessary specifically designed to address women s needs Project Narrative The purpose of this proposal is to develop a novelcollapsible vaginal pessary for the non surgical treatment of pelvic organ prolapsePOPa condition which symptomatically affectsmillion women in the United StatesRecent medical studies suggest that surgical treatments for POP are less effective than once believedand current pessaries in common use are limited by a rigid and fixed design which can make them uncomfortable as well as difficult or impossible for patients to remove and insert independentlyConsequentlythere is an imperative to develop non surgical treatment alternatives for women who suffer with POP which are easy to useacceptedeffectivecomfortableand cause minimal complications