Disposable Valved Intraurethral Catheter Feasibility

一次性带阀尿道内导管的可行性

• 批准号: 7448641
• 负责人: Harvey D Homan
• 金额: $ 24.05万
• 依托单位: UROVALVE, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-20 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7448641
• 关键词: Acute; Adverse event; Bladder; Bladder Calculi; Boston; Caregivers; Caring; Case Report Form; Catheterization; Catheters; Characteristics; Chronic; Class; Clinic; Clinical; Clinical Research; Collaborations; Condition; Consent Forms; Contracts; Cross-Over Studies; Daily; Data; Dependence; Development; Devices; Documentation; Effectiveness; Environment; Excision; Exposure to; Feasibility Studies; Freedom; Funding; Health; Health Benefit; Health Personnel; Health Professional; Healthcare Systems; Home environment; Human; Hypertrophy; Individual; Informed Consent; Kidney Diseases; Laboratories; Lead; Life; Manufacturer Name; Mechanics; Medical; Methods; Morbidity - disease rate; Multiple Sclerosis; Neurologic; Numbers; Operative Surgical Procedures; Patient Care; Patients; Pattern; Performance; Phase; Physicians; Positioning Attribute; Procedures; Process; Prostate; Protocols documentation; Qualifying; Quality of life; Rate; Reliance; Reporting; Research Ethics Committees; Risk; Safety; Self Perception; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Solutions; Spinal cord injury; Staging; Standards of Weights and Measures; Sterilization for infection control; System; Technology; Testing; Time; Trauma; United States Food and Drug Administration; Urethra; Urinary Retention; Urinary tract; Urinary tract infection; Urination; Urologist; Validation; Veterans; Week; Writing; compare effectiveness; cost; cost effectiveness; day; design; desire; experience; improved; innovation; male; men; migration; nervous system disorder; prototype; research and development; size; tool

DESCRIPTION (provided by applicant): The objectives of this proposed Phase II SBIR project are to refine the SurinateTM disposable valved intraurethral catheter to make it easier for the patient to operate, more reliable and easier to insert and extract than the prototype that was tested in the Phase I SBIR feasibility study. The effectiveness and safety of the refined design will be demonstrated in a pilot clinical study. Surinate(tm) is intended to treat chronic male urinary retention (such as that caused by spinal cord injury and neurological diseases) and acute male urinary retention (such as that caused by prostrate hypertrophy). The valved catheter is controllable by the patient and will be an innovative treatment alternative for users of Foley and intermittent catheters, allowing patients the freedom to urinate at their convenience, thereby improving the quality of life for an estimated 375,000 men who must deal with chronic urinary retention due to spinal cord injury (SCI), late-stage multiple sclerosis, and other neurological conditions. Despite improvements in medical care, these patients continue to experience significant morbidity related to their urinary tracts. Much of this morbidity is due to the limitations of indwelling, intermittent and external catheter technology, which has not significantly improved in decades. Surinate(tm) offers many of the benefits of intermittent catheterization, but should be much easier to use and cause significantly fewer urinary tract problems. The Surinate(tm) valved catheter is designed to be easily inserted into the urethra without surgery, extracted easily, and replaced every 28 days. The Phase I feasibility study demonstrated that the valve was mechanically reliable, and that the valved catheter could be inserted successfully without surgery and remained stable in the urethra. Although there were a tolerable number of adverse events, none was serious or unanticipated. Improvements are intended to make the insertion procedure simpler; the valved catheter easier for the patient to operate; increase flow rate; and simplify removal using the extraction tool. The objectives of the Phase II effort are to: (1) develop and manufacture prototype units; (2) conduct design verification testing to demonstrate that desired performance characteristics have been achieved with the prototypes; (3) transfer manufacturing of the Surinate(tm) devices to an FDA- approved contract manufacturer that meets ISO 13485 standards, (4) perform laboratory verification testing of the manufactured devices at Urovalve, Inc., (5) Finalize Case Report Forms and Informed Consent ; obtain approval from FDA for an Investigational Device Exemption and Institutional Review Board approval to conduct the human clinical under the protocol that has been written in collaboration with the Boston VA Healthcare System and (6) conduct the Phase II pilot clinical to demonstrate safe and effective operation of all components in both clinical and home-use settings. Up to 40 male veterans with SCI will be screened to have 20 patients complete a crossover study to compare the effectiveness and safety of the Surinate(tm) disposable intraurethral valved-catheter to intermittent catheterization during a 30 day period (14 days using each device). RESEACH & RELATED: Other Project Information Item 7: Project Narrative The Surinate(tm) catheter system will bring dramatic improvement to the health and qualify of life for many individuals who suffer urinary retention, including those due to spinal cord injury. No devices currently available or known to be in development for patients who suffer urinary retention combine the utility, ease of use, and health benefits and cost effectiveness of SurinateTM. The SurinateTM catheterization system offers solutions to the problems of quality of life, urinary tract infections, and substantial reliance on healthcare workers associated with the existing catheters. Neither urologists nor patients consider currently available devices to be satisfactory to the patients' comfort, cost of care, or medical performance.

描述（由申请人提供）：该提出的II期SBIR项目的目标是优化Surinatetm可一次性瓣膜内导管，以使患者更容易操作，比在I阶段I SBIR可行性研究中进行的原型更容易插入和更易于插入和提取。精制设计的有效性和安全性将在试点临床研究中证明。 Suration（TM）旨在治疗慢性男性尿尿位（例如由脊髓损伤和神经系统疾病引起的）和急性男性尿retention留（例如由肥大肥胖引起的）。 The valved catheter is controllable by the patient and will be an innovative treatment alternative for users of Foley and intermittent catheters, allowing patients the freedom to urinate at their convenience, thereby improving the quality of life for an estimated 375,000 men who must deal with chronic urinary retention due to spinal cord injury (SCI), late-stage multiple sclerosis, and other neurological conditions.尽管医疗服务有所改善，但这些患者仍会经历与尿路有关的明显发病率。这种发病率的大部分是由于留置，间歇性和外部导管技术的局限性，几十年来一直没有显着改善。 Surate（TM）提供了间歇性导管插入术的许多好处，但应该更容易使用并引起尿路问题明显更少。液压（TM）阀导管设计为在不手术的情况下轻松插入尿道，轻松提取并每28天更换一次。第一阶段的可行性研究表明，该阀在机械上是可靠的，并且可以在不手术的情况下成功插入阀导管，并且在尿道中保持稳定。尽管有很多不良事件数量，但没有一个是严重的或意外的。改进旨在使插入过程变得更简单；阀导管使患者更容易手术；增加流速；并使用提取工具简化去除。第二阶段工作的目标是：（1）开发和制造原型单元； （2）进行设计验证测试以证明原型已经实现了所需的性能特征； （3）将Surinate（TM）设备的制造转移到符合ISO 13485标准的FDA批准的合同制造商，（4）在Urovalve，Inc。对制造设备进行实验室验证测试，（5）最终确定案例报告表格和知情同意书；获得FDA的批准，以根据与波士顿VA Healthcare System合作编写的协议进行调查设备的豁免和机构审查委员会批准，并（6）进行II期飞行员临床，以证明所有组件在临床和家庭用途设置中的安全有效操作。将筛查多达40名具有SCI的男性退伍军人，以使20名患者完成一项跨界研究，以比较在30天（使用每种设备14天）内（使用每种设备14天）在30天（14天）内进行液压和安全性。参见与相关：其他项目信息项目7：项目叙述含量（TM）导管系统将为许多遭受尿retention留的人（包括脊髓损伤引起的尿位）带来巨大的改善和生活资格。目前尚无针对遭受尿retention留的患者开发或已知正在开发的设备，可以将苏里纳特省的效用，易用性以及健康福利和成本效益结合在一起。 Surinatetm导管插入系统为生活质量，尿路感染以及对与现有导管相关的医疗人员的严重依赖提供了解决方案。泌尿科医生和患者都没有认为目前可用的设备对患者的舒适性，护理成本或医疗表现感到满意。