A SYSTEM FOR MEASURING PELVIC MUSCLE STRENGTH IN WOMEN

当压力性尿失禁开始在年轻的时候，通常是在阴道分娩后，它引发了一个终身的问题。尿失禁的累积发病率随着年龄的增长而增加，65岁以上的女性中有38%受到影响。骨盆肌肉力量的评估是这些患者的常见临床测试。然而，骨盆肌肉力量的测量目前要么是主观的，要么包含伪影，通常是由于测量的非等距性质。在本研究项目的第一阶段，将开发一种新的系统，用于直接测量在剧烈咳嗽和瓦尔萨尔瓦氏激发试验期间女性骨盆底肌肉的最大随意等长力量和收缩特性。该系统的核心是一种新型的阴道内换能器，这是最近发明公开的主题。该系统将使用微型计算机进行改进，然后使用嵌入式微控制器进行小型化。将对30名妇女进行可行性测试。该装置可用于妇科医生、临床护士和物理治疗师评估骨盆底功能，评估运动干预的有效性，并作为生物反馈装置用于培训适当的技术。将在第II阶段对原型系统性能进行详尽的临床评估和优化。拟议的商业应用：我们的目标是提供一种低成本，易于使用的产品，将安全，准确地测量成年女性的骨盆底肌肉力量。该设计将使医生、执业护士和物理治疗师能够进行诊所内测试。它的便携性将使家庭使用的妇科评估和多周的运动干预作为一个生物反馈训练设备。该器械的市场广泛，用于二级和三级护理医院、普通妇产科诊所、学术研究实验室以及由临床护士、护士和物理治疗师经营的门诊诊所。我们预计销售量将达到数万台，估计零售成本约为5，000台。

When stress urinary incontinence begins at a young age, often after giving vaginal birth, it initiates a lifelong problem. The cumulative incidence of urinary incontinence increases with age, affecting up to 38% of women over the age of 65 years. Assessment of pelvic muscle strength is a common clinical test for these patients. However, measurements of pelvic muscle strength are presently either subjective or contain artifact, commonly due to the non-isometric nature of the measurements. During Phase I of this research project a new system will be developed for directly measuring maximum voluntary isometric strength and contractile properties of the female pelvic floor muscles during hard coughs and valsalva provocation tests. The centerpiece of the system is a novel intravaginal transducer, the subject of a recent invention disclosure. The system will be refined using a microcomputer, then miniaturized with embedded microcontrollers. Feasibility tests will be conducted on 30 women. The device has utility for gynecologists, nurse-clinicians and physical therapists in assessing pelvic floor function, evaluating the efficacy of exercise interventions, and as a biofeedback device for training proper technique. Exhaustive clinical assessment and optimization of prototype system performance will be conducted in Phase II. PROPOSED COMMERCIAL APPLICATIONS: Our goal is to provide a low-cost, easy-to-use product that will safely and accurately measure pelvic floor muscle strength in adult women. The design will enable in-clinic testing by physicians, nurse- practitioners and physical therapists. Its portability will enable in-home use for gynecological assessments and multi-week exercise interventions as a biofeedback training device. The market for the device is widespread with use in secondary and tertiary care hospitals, general obstetric and gynecological clinics, academic research laboratories, and outpatient clinics run by nurse clinicians, nurses and physical therapists. We anticipate sales volume to be many tens of thousands of units at an estimated retail cost of approximately 5,000 each.