A System For Measuring Pelvic Muscle Strength In Women

描述（由申请人提供）：九分之一的女性患有骨盆底功能障碍，包括尿失禁和阴道壁或子宫脱垂（VUP）。压力性尿失禁（SUI）影响了38%的65岁以上的女性和超过1300万的美国女性。在这些患者中通常评估骨盆肌肉力量。然而，目前的测量技术是主观的或产生伪影，由于其非等距性质或污染的腹内压。在第一阶段，我们开发了第二代系统，测量女性骨盆底肌肉的等长力量和收缩特性。该系统的核心是一种新型的阴道内传感器，可以区分腹内压和肛提肌力。在第二阶段，系统的机械、电子和软件将得到改进，以提高系统的灵敏度、准确性和易用性。将开发和验证基于膝上型计算机和个人数据助理的系统。将通过检验120名女性（40名健康大陆女性，40名VUP女性，40名SUI女性）的零假设来确认临床器械性能，即MR扫描上可见的局部盆底肌肉缺损与骨盆肌无力相关。该系统允许评估骨盆底功能和运动干预功效，并且可以在训练期间提供生物反馈和依从性数据。

DESCRIPTION (provided by applicant): One in nine women suffer from pelvic floor dysfunction, including urinary incontinence and vaginal wall or uterine prolapse (VUP). Stress urinary incontinence (SUI) affects 38% of women over the age of 65 years and over 13 million women in the United States. Pelvic muscle strength is commonly assessed in these patients. However, current measurement techniques are either subjective or produce artifact, due to their non-isometric nature or contamination by intraabdominal pressure. During Phase I, we developed a second generation system that measures the isometric strength and contractile properties of female pelvic floor muscles. The system centerpiece is a novel intravaginal transducer that differentiates between intraabdominal pressure and levator ani force. During Phase II, system mechanics, electronics and software will be refined to improve system sensitivity, accuracy, and ease-of-use. Laptop- and Personal Data Assistant-based systems will be developed and validated. Clinical device performance will be confirmed by testing the null hypothesis in 120 women (40 healthy continent, 40 with VUP, 40 with SUI) that localized pelvic floor muscle defects visible on MR scans will correlate with pelvic muscle weakness. The system allows assessment of pelvic floor function and exercise intervention efficacy, and can provide biofeedback and adherence data during training.