Urinary incontinence (UI) is experienced by an estimated 51% of women in the U.S. and often results from impaired function or weakening of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a frontline nonsurgical treatment, yet a number of symptomatic individuals cannot accurately perform a pelvic floor muscle contraction with simple verbal or written instruction. Long-term adherence to PFMT regimens is often a barrier to resolution of symptoms. Various biofeedback tools have been utilized to aid correct pelvic floor muscle performance and adherence. One novel device, the leva® Pelvic Digital Health System, utilizes an intravaginal probe embedded with MEMS accelerometer sensors that allow real-time visualization of the shape and motion of the vagina during PFMT. Early positive results with this device prompted design of a wearable version. The purpose of this study was to design a wearable, wireless clinical research device to optimize MEMS accelerometer sensor placement to detect maximal movement during a pelvic floor muscle exercise (PFME) and to test the form factor for retention and user acceptability. The device comprised a ring designed to sit at the fornix with an extension following the length of the vagina. This paper presents design components and results from clinical testing of 10 subjects. It was determined that a ring form factor alone, similar to other vaginal rings (pessaries, estrogen rings) provided less accurate visual information about PFME performance. By contrast, we determined that a ring with an extension allowed for device retention and improved real-time detection of vaginal shape and motion during PFMT.

中文翻译：

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开发基于无线加速度计的阴道内装置，以检测骨盆底运动，以评估骨盆底功能障碍。

在美国，估计有51％的女性患有尿失禁（UI），通常是由于功能障碍或骨盆底肌肉衰弱所致。骨盆底肌肉训练（PFMT）是一线非手术治疗，但是许多有症状的个体无法通过简单的口头或书面指导准确地进行骨盆底肌肉收缩。长期坚持PFMT疗法通常是缓解症状的障碍。已经利用各种生物反馈工具来帮助校正骨盆底肌肉的性能和附着力。一种新颖的装置，leva®Pelvic数字医疗系统，利用嵌入了MEMS加速度计传感器的阴道内探头，可以在PFMT期间实时观察阴道的形状和运动。该设备的早期正面结果促使人们设计了可穿戴版本。这项研究的目的是设计一种可穿戴的无线临床研究设备，以优化MEMS加速度计传感器的放置，以检测骨盆底肌肉运动（PFME）期间的最大运动，并测试保持力和用户接受度的形状因数。该装置包括一个环，该环设计为坐在阴道旁，并随着阴道的长度而延伸。本文介绍了10个受试者的临床试验设计结果和结果。已确定，单独的环形状因子类似于其他阴道环（子宫托，雌激素环）提供的关于PFME性能的视觉信息不太准确。相比之下，我们确定了带有延伸部分的环可保留设备并改善PFMT期间阴道形状和运动的实时检测。