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).

摘要 Bold Type正在开发“SmartWand”，这是一种交互式连接的骨盆底系统（设备和 移动的应用程序），以指导患者在家中进行骨盆底物理治疗（PT）。PT 是高张力骨盆底功能障碍（HTPFD）的高效一线治疗方法， 慢性盆腔疼痛（CPP），影响美国高达15%的女性。尽管有效性已被证明，但只有 20%的女性完成了PT治疗过程，其中包括家庭锻炼和外部锻炼。 和内部锻炼方案。女性报告继续PT的时间、费用、治疗途径、 缺乏来自国内项目的直接反馈，无法衡量国内的进展。 Bold Type的团队在医疗器械、质量和监管方面拥有数十年的产品开发经验 按照政事我们开发了专有的硬件和软件开发工具包，使我们能够设计和 通过利用设计和记录的可重复使用的子系统来有效地实施医疗设备， 符合FDA规定。为了满足可获得和改善PT的关键需求，我们假设： (1)符合人体工程学的棒设计将提高可用性，（2）执行PT的创新系统可以 为物理治疗师和患者提供指导和生物反馈;（3）患者将 能够使用平台提供的指导和生物反馈有效地执行PT。 我们提出了以下具体目标为这个项目：1）最终的魔杖设计，从三个初步 使用人为因素验证测试设计原型。一个形成性的可用性评估的三个初步 将在15名有机械刀头经验的HTPFD患者中进行刀头原型测试，以确定首选 设计特点我们将在骨盆底物理治疗师的监督下进行模拟使用测试， 使用无动力装置原型系统地收集来自测试参与者的数据; 2）开发无线， 手持“SmartWand”和移动的应用程序，（1）记录压力和位置（深度和方向）， 女性骨盆与骨盆底肌肉的关系，（2）在棒上为用户提供音频和视觉反馈 压力、位置和方向，以及（3）将数据传输到数据库以进行存储和分析;以及 该系统在特定目标2中对10名健康女性和10名患有HTPFD的女性进行了开发。妇女 >18年将被招募的恩典物理治疗和治疗师分配到执行压力疼痛 阈值和刀头使用说明。Aim 3的成功指标是，在应用程序的指导下， 参与者将能够进行魔杖练习，与测量结果相比， 通过PT（施加压力的15%以内，角度/方向为5度，插入深度为8 mm以内）。