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 Type 正在开发“SmartWand”，这是一种交互式、互联的盆底系统（设备和设备） 移动应用程序）指导患者在家中进行盆底物理治疗（PT）。 是治疗高张力盆底功能障碍 (HTPFD) 的高效一线疗法，该功能障碍是导致盆底肌张力障碍的主要原因 慢性盆腔疼痛 (CPP)，影响着多达 15% 的美国女性，尽管已被证明有效，但仅此而已。 20% 的女性完成了 PT 治疗课程，其中包括家庭锻炼和外部锻炼 女性报告了持续 PT 的局限性，如时间、费用、获得治疗的途径、 缺乏来自家庭计划的直接反馈，并且无法衡量家庭的进展。 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 我们开发了专有的硬件和软件开发套件，使我们能够设计和处理事务。 通过利用可重复使用的子系统来有效地实施医疗设备，这些子系统的设计和记录是为了 遵守 FDA 法规，为了满足可访问和改进 PT 的关键需求，我们合作： (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 开发为物理治疗师和患者提供指导和生物反馈；(3) 患者将： 能够利用平台提供的指导和生物反馈有效地进行 PT。 我们为该项目提出以下具体目标： 1）根据三个初步目标确定魔杖设计 使用人为因素验证测试设计原型，对三个初步的可用性进行评估。 魔杖原型将在 15 名机械魔杖经验丰富的 HTPFD 患者中进行，以确定首选 我们将在盆底物理治疗师的监督下进行模拟使用测试，并 使用未供电的设备原型彻底收集测试参与者的数据； 手持式“SmartWand”和移动应用程序 (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) 为用户提供魔杖的音频和视觉反馈 压力、位置和方向，(3) 将数据传输到数据库进行存储和分析，以及 3) 验证； 该系统在特定目标 2 中针对 10 名健康女性和 10 名 HTPFD 女性进行开发。 Grace Physical Therapy 将招募年满 18 岁以上的治疗师并指派进行压痛治疗 魔杖使用的阈值和说明 目标 3 的成功指标是在应用程序的指导下， 与测量结果相比，参与者将能够以最小的差异进行魔杖练习 由 PT 控制（施加压力的 15% 以内，角度/方向 5 度，插入深度 8 毫米以内）。