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

项目摘要/摘要 该SBIR第二阶段项目的主要目标是评估安全性、有效性和用户 连接的导管系统(CC)的满意度。脊柱奇点将CC发展为完全内部的， 无线控制尿路假体旨在显著提高男性尿路疾病患者的生活质量 并最终降低与导管相关的医疗并发症的发生率，如 尿路感染(UTIs)和生殖-泌尿系统损伤。CC完全驻留在男性下部的内部 尿路(LUT)，其远端位于阴茎中部的尿路，延长使用寿命长达29天。 远端导尿管末端结合了一个磁性阀泵，使膀胱能够自然填充，并 用户可以使用手持无线控制器控制排尿。通过完全驻留在身体内并使 用户可以舒适方便地排空膀胱，而不需要频繁的导尿或体外循环 作为一种引流设备，CC既有潜力显著提高其使用者的泌尿外科生活质量 并降低相关临床并发症的发生率和医疗费用，包括尿路感染和创伤。 此外，与清洁间歇相比，CC可显著降低持续供应成本 导尿术。在这个第二阶段的项目中，CC系统将首先经历一系列临床前设计 验证和验证测试。然后，CC将在一项临床研究中用于多达30名用户，旨在 检查可行性和安全性。这项单臂研究的特点是对CC的使用情况进行了三个月的监测，并将 确定CC的临床安全性和可行性。我们预计CC将易于使用，并将 提高用户在生活质量和CC用户调查中的满意度得分。该项目将提供一些 支持CC随后提交监管机构进行美国市场清算所需的数据，以及 为在IIb期进行更广泛的临床试验奠定基础。最终目标是让这一点变得更好 数以百万计依赖导尿的男性可以使用膀胱管理技术。

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.