The Urethral Sleeve Sensor_A Novel Method of Measuring Urethral Pressure

尿道套传感器_测量尿道压力的新方法

• 批准号: 8029451
• 负责人: CHARLES William NAGER
• 金额: $ 19.32万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8029451
• 关键词: Bladder; Bladder Control; Caliber; Catheters; Clinical; Clinical Research; Coughing; Data; Development; Devices; Diagnosis; Diagnostic tests; Exercise; Frequencies; Incontinence; Intra-abdominal; Length; Liquid substance; Measurement; Measures; Methods; Muscle Contraction; Operative Surgical Procedures; Pelvic Floor Muscle; Pelvic floor structure; Pelvis; Perfusion; Phase; Physiological; Postoperative Period; Procedures; Recruitment Activity; Research; Resistance; Rest; Silicones; Stress; Stress Urinary Incontinence; Surgeon; Technology; Testing; Training; Urethra; Urodynamics; Urologist; Vagina; Withdrawal; Woman; Work; abdominal pressure; clinical application; design; improved; instrument; novel; pressure; research study; response; sensor; success; tool; volunteer

DESCRIPTION (provided by applicant): Dynamic activities increase intra-abdominal pressure (i.e. coughing, straining) resulting in a corresponding increase in bladder pressure. When this bladder pressure exceeds urethral pressure, stress urinary incontinence occurs. It has been universally acknowledged that our tools for measuring urethral pressure to diagnose stress urinary incontinence are flawed. Current instruments are withdrawn through the length of the urethra with a puller device and can only measure urethral pressure at small discrete points while the urethra is at rest. We are studying a new method (perfused sleeve sensor technology) for directly measuring urethral pressures during dynamic conditions. The sleeve sensor consists of a thin-walled silicone sleeve that is attached to the catheter and is constantly perfused with fluid. The unique quality of this perfused sleeve is its ability to record maximum pressure measurements anywhere along the length of the sleeve without requiring withdrawal of the catheter. Our preliminary data supports the ability of the urethral sleeve sensor to directly measure maximum urethral closure pressure within the urethra both during rest and dynamic activities. Currently there are no objective parameters for surgical cure of stress urinary incontinence; a deficiency in our diagnostic testing capabilities which is widely recognized by pelvic reconstructive surgeons. This two- phase study will determine if sleeve sensor technology can provide an objective urodynamic measure of cure. Phase 1 involves catheter design and optimization. Recruiting 16 continent volunteers will allow us to test the urethral sleeve sensor with different perfusion rates and luminal diameters in order to develop the optimal catheter which will then be used in Phase 2. The primary aim of Phase 2 is to compare the maximum urethral closure pressures during valsalva before and after surgical intervention for stress urinary incontinence with a mid-urethral sling. We hypothesize that urethral closure pressure during valsalva in stress incontinent subjects, as measured using the urethral sleeve sensor, will convert from 0 cm H2O to a positive value after mid-urethral sling surgery. This fundamental definition of incontinence and continence has never been demonstrated with any other urethral pressure technology. Our secondary aim will be to understand the mechanism of pelvic floor contraction for improving urinary continence by correlating vaginal pressure measurements obtained during pelvic floor muscle contractions with urethral pressures using the urethral sleeve sensor. During Phase 2, 34 subjects with stress urinary incontinence desiring surgical therapy will undergo preoperative and postoperative sleeve urodynamic urethral pressure studies as well as vaginal pressure studies. The impact of this study is that we may demonstrate and validate the first physiologic measurement tool of incontinence cure for both research studies and clinical usage. PUBLIC HEALTH RELEVANCE: We are studying a new method (perfused sleeve sensor technology) for directly measuring urethral pressures during dynamic conditions. Currently there are no objective parameters for surgical cure of SUI; a deficiency in our diagnostic testing capabilities which is widely recognized by pelvic reconstructive surgeons because currently available methods are unable to assess urethral pressures during dynamic conditions. This study will determine if sleeve sensor technology can provide an objective urodynamic measure of cure.

描述(由申请人提供)：动态活动增加腹内压力(即咳嗽、拉力)，导致膀胱压力相应增加。当膀胱压力超过尿路压力时，就会发生压力性尿失禁。人们普遍认为，我们用于诊断压力性尿失禁的测量尿压的工具是有缺陷的。目前的仪器是用拉杆装置从整个尿路抽出，当尿路静止时，只能测量较小的离散点处的尿路压力。我们正在研究一种在动态条件下直接测量尿路压力的新方法(灌流套筒传感器技术)。套筒传感器由连接在导管上的薄壁硅胶套筒组成，并不断注入液体。这种灌流套筒的独特之处在于，它能够记录沿套筒长度的任何位置的最大压力测量，而不需要拔出导管。我们的初步数据支持尿道套传感器在静息和动态活动时直接测量尿路内的最大尿路闭合压力的能力。目前，对于压力性尿失禁的外科治疗还没有客观的参数；我们的诊断测试能力不足，这是骨盆重建外科医生广泛认识到的。这项分两个阶段进行的研究将确定袖式传感器技术是否可以提供客观的尿动力学治疗措施。第一阶段涉及导管的设计和优化。招募16名大陆志愿者将允许我们测试不同灌注率和管腔直径的尿道套传感器，以开发出最优的导尿管，然后用于第二阶段。第二阶段的主要目标是比较Valsalva手术治疗压力性尿失禁手术前后的最大尿路闭合压力。我们假设，在压力性尿失禁患者的Valsalva期间，使用尿道套传感器测量的尿路闭合压力在尿路中吊带手术后将从0 cm H2O转换为正值。这种对大小便失禁和大小便失禁的基本定义，在其他任何一种尿路压力技术中从未被证明过。我们的第二个目标将是通过将盆底肌肉收缩期间获得的阴道压力测量与使用尿道套传感器的尿路压力相关联来了解盆底收缩改善尿控的机制。在第二阶段，34名需要手术治疗的压力性尿失禁患者将接受术前和术后袖状尿路动力尿压研究以及阴道压力研究。这项研究的影响是，我们可以为研究和临床应用展示和验证第一个治疗失禁的生理学测量工具。 与公众健康相关：我们正在研究一种新的方法(灌流袖式传感器技术)，可以在动态条件下直接测量尿路压力。目前，SUI的外科治疗尚无客观指标；我们的诊断测试能力不足，这是骨盆重建外科医生广泛认识到的，因为现有的方法无法评估动态条件下的尿路压力。这项研究将确定袖式传感器技术是否可以提供客观的尿动力学治疗措施。