A device to treat high-tone pelvic floor dysfunction in women

一种治疗女性高音盆底功能障碍的装置

• 批准号: 10697072
• 负责人: Jose Luis Bohorquez
• 金额: $ 38.5万
• 依托单位: BOLD TYPE LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10697072
• 关键词: Accelerometer; Affect; Biofeedback; Bluetooth; Calibration; Cellular Phone; Certification; Cues; Data; Data Analyses; Databases; Devices; Dimensions; Dyspareunia; Effectiveness; Electronics; Evaluation; Exercise; Feedback; Female; Functional disorder; Growth; Home; Hospitals; Human; Interstitial Cystitis; Intestines; Irritable Bowel Syndrome; Length; Letters; Location; Maps; Marketing; Measurement; Measures; Mechanics; Medical Device; Muscle; Occupations; Outcome; Outcome Measure; Pain; Pain Disorder; Pain Threshold; Participant; Patients; Pelvic Floor Muscle; Pelvic Pain; Pelvic floor dysfunction; Pelvic floor structure; Pelvis; Physical therapy; Positioning Attribute; Privacy; Production; Quality of life; Questionnaires; Records; Regulation; Regulatory Affairs; Relaxation; Reporting; Resources; Sales; Shapes; Shipping; Site; Space Perception; Supervision; Symptoms; System; Testing; Time; United States; Vagina; Validation; Validity and Reliability; Visual; Vulvodynia; Woman; central database; chronic pelvic pain; comorbidity; cost; data exchange; design; effective therapy; endometriosis; ergonomics; exercise regimen; experience; force sensor; improved; innovation; mobile application; novel; physical therapist; pressure; primary outcome; product development; programs; prototype; recruit; sensor; software development; success; usability; vibration; visual feedback; wireless

Abstract Bold Type is developing the “SmartWand”, an interactive, connected pelvic floor system (device and mobile app) to guide patients through pelvic floor physical therapy (PT) in the privacy of their home. PT is a highly effective and first-line treatment for high tone pelvic floor dysfunction (HTPFD), a major contributor to chronic pelvic pain (CPP), affecting up to 15% of women in the United States. Despite proven effectiveness, only 20% of women complete the PT treatment course, which includes a home exercise component with an external and internal exercise regimen. Women report limitations in continuing PT as time, cost, access to therapy, the lack of direct feedback from the home program and the inability to measure progress at home. Bold Type’s team has decades of product development experience with medical devices, quality, and regulatory affairs. We have developed proprietary hardware and software development kits that allow us to design and implement medical devices efficiently by leveraging reusable subsystems that are designed and documented to comply with FDA regulations. To meet the critical need for accessible and improved PT, we hypothesize that: (1) an ergonomic wand design will improve usability, (2) an innovative system for performing PT can be developed that provides guidance and biofeedback to physical therapists and patients; and (3) patients will be able to effectively perform PT using the guidance and biofeedback provided by the platform. We propose the following Specific Aims for this project: 1) Finalize the wand design from three preliminary design prototypes using human factors validation testing. A formative usability evaluation of three preliminary wand prototypes will be conducted in 15 mechanical wand experienced HTPFD patients to identify preferred design features. We will use simulated-use testing under the supervision of a pelvic floor physical therapist and systematically collect data from test participants using the unpowered device prototype; 2) Develop a wireless, handheld “SmartWand” and mobile app that (1) records pressure and location (depth and orientation) in the female pelvis in relation to the pelvic floor muscles, (2) provides the user audio and visual feedback on wand pressure, position, and orientation, and (3) transfers data to a database for storage and analysis; and 3) Validate the system developed in Specific Aim 2 on a group of 10 healthy women and 10 women with HTPFD. Women >18 years will be recruited by Grace Physical Therapy and therapists assigned to perform pressure pain thresholds and instruct on wand use. The success metric for Aim 3 is that with guidance from the app, the participants will be able to perform wand exercises with minimal variance as compared to measurements made by the PT (within 15% of applied pressure, 5 degrees of angle/orientation and within 8 mm of insertion depth).

抽象的 Bold类型正在开发“智能Wand”，这是一种交互式，连接的骨盆底系统（设备和 移动应用程序）指导患者在房屋的私密性中通过骨盆底物理疗法（PT）。 pt 是高音骨盆底功能障碍（HTPFD）的高效和一线治疗 慢性骨盆疼痛（CPP）影响美国多达15％的妇女。尽管有效，但只有 20％的妇女完成PT治疗课程，其中包括带有外部的家庭锻炼组成部分 和内部运动方案。妇女报告持续PT作为时间，成本，获得治疗的限制， 家庭计划缺乏直接反馈，无法衡量在家中的进度。 Bold Type的团队在医疗设备，质量和监管方面拥有数十年的产品开发经验 事务。我们已经开发了专有的硬件和软件开发套件，使我们能够设计和 通过利用设计和记录到的可重复使用子系统来有效地实施医疗设备 符合FDA法规。为了满足可访问和改善的PT的关键需求，我们假设这一点： （1）符合人体工程学的魔杖设计将提高可用性，（2）用于执行PT的创新系统可以是 为物理治疗师和患者提供了指导和生物反馈的开发； （3）患者将是 可以使用平台提供的指导和生物反馈有效地执行PT。 我们提出了以下针对该项目的特定目标：1）从三个初步的魔杖设计最终确定魔杖设计 使用人为因素验证测试设计原型。三个初步的形成性可用性评估 魔杖原型将在15个机械棒经历的HTPFD患者中进行，以识别首选 设计功能。我们将在骨盆底物理治疗师的监督下使用模拟使用测试 使用未经动荡的设备原型从测试参与者那里收集数据； 2）开发无线， 手持式“智能Wand”和移动应用程序（1）记录了压力和位置（深度和方向） 雌性骨盆与骨盆底肌肉有关，（2）提供了用户音频和视觉反馈 压力，位置和方向，（3）将数据传输到数据库进行存储和分析； 3）验证 该系统在特定的目标2中开发了10名健康女性和10名HTPFD女性的系统。女性 > 18年将由恩典的物理疗法和分配的治疗师招募压力疼痛 阈值和指导使用魔杖。 AIM 3的成功指标是，在应用程序的指导下 与进行的测量相比 通过PT（在施加压力的15％以内，角度/方向的5度及其插入深度8 mm之内）。