A SYSTEM FOR MEASURING PELVIC MUSCLE STRENGTH IN WOMEN

当压力性尿失禁在很小的时候就开始了，通常是在阴道分娩之后，它会引发一个终生的问题。尿失禁的累积发病率随着年龄的增长而增加，65岁以上的女性中有高达38%的人受到影响。对这些患者来说，评估骨盆肌力是一项常见的临床测试。然而，目前骨盆肌肉力量的测量要么是主观的，要么含有伪影，通常是由于测量的非等距性质所致。在该研究项目的第一阶段，将开发一种新的系统，用于在剧烈咳嗽和Valsalva激发试验中直接测量女性盆底肌肉的最大自愿等长强度和收缩特性。该系统的中心部件是一种新型的阴道内换能器，该换能器是最近一项发明公开的主题。该系统将使用微型计算机进行精细化，然后使用嵌入式微控制器进行小型化。可行性测试将在30名女性身上进行。该装置对妇科医生、护士-临床医生和理疗师评估盆底功能、评估运动干预的效果以及作为训练适当技术的生物反馈装置具有实用价值。在第二阶段将进行详尽的临床评估和原型系统性能的优化。建议的商业应用：我们的目标是提供一种低成本、易用的产品，可以安全和准确地测量成年女性的盆底肌肉力量。该设计将使医生、执业护士和理疗师能够进行诊所内测试。它的便携性将使其能够在家中用于妇科评估和作为生物反馈训练设备的数周运动干预。该设备的市场很广泛，在二级和三级保健医院、普通产科和妇科诊所、学术研究实验室以及由护士临床医生、护士和理疗师运营的门诊诊所使用。我们预计销售量将达到数万台，估计每台的零售成本约为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.