Soft Spring Continence Pessary for Women

女性软弹簧节制子宫托

• 批准号: 10388403
• 负责人: Lisa Hickman
• 金额: $ 72.25万
• 依托单位: LIV LABS INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-09 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10388403
• 关键词: Acute; Adoption; Affect; Age; American; Anatomy; Anterior; Atrophic; Bladder; Caregivers; Caring; Chronic Disease; Client satisfaction; Clinic; Clinical; Computer software; Consumption; Coughing; Cream; Development; Devices; Diagnosis; Engineering; Enrollment; Ensure; Estrogens; Excision; Exercise; Exertion; Feasibility Studies; Female; Fingers; Focus Groups; Frequencies; Goals; Health; Home; Human; Incontinence; Injury; Institutional Review Boards; Journals; Laceration; Lead; Left; Legal patent; Length; Life; Lifting; Lubricants; Manuals; Medical; Medical Device; Minor; Modeling; Operative Surgical Procedures; Output; Pain; Participant; Patient Education; Patients; Pelvic Floor Muscle; Pelvic floor structure; Pelvis; Pessaries; Phase; Physical Fitness; Population; Prevalence; Public Health; Quality of life; Questionnaires; Reporting; Research; Resources; Risk; Risk Assessment; Running; Safety; Security; Self Administration; Self Management; Services; Severities; Silicones; Sneezing; Specialist; Stress Tests; Stress Urinary Incontinence; Surface; Surveys; Symptoms; System; Technology; Testing; Time; Tissues; Toxic effect; Training; Treatment Efficacy; Uncertainty; Universities; Urethra; Urine; Vagina; Visit; Walking; Weight; Weight Gain; Well in self; Woman; aging in place; arm; biomaterial compatibility; career; clinical care; consumer product; cost; design; design verification; efficacy study; experience; fitness; flexibility; follow-up; improved; incontinence symptom; mechanical energy; medical schools; novel; novel strategies; open label; pre-clinical; preference; pressure; primary endpoint; programs; promoter; prospective; psychologic; research clinical testing; satisfaction; secondary endpoint; side effect; statistics; symptom treatment; usability

Project Summary/Abstract Liv Labs has developed a novel, reusable, self-administered silicone pessary for patient-controlled treatment of female stress urinary incontinence (SUI), a bothersome condition that affects some 27 million American women over the age of 25. Unlike the fitted and disposable pessaries available on the market today, this patent- pending Soft Spring Continence Pessary is a symmetrical, hollow, resilient form placed above the pelvic floor— not to kink the urethra, as other effective devices and surgical procedures do, but rather to gently compress the urethra through soft, vaginal tissue. The device compresses down into a 10mm cylinder for applicator-assisted insertion and features an integrated finger loop for easy manual removal. Comprising only soft, rounded surfaces, the spring pessary can be lubricated and is intended for patients with vaginal atrophy who sometimes experience pain, lacerations, or injury with existing devices. The Liv Labs team has already completed bench testing, focus groups, caregiver assessments, design review with clinicians, and a two-week, IRB-approved, pilot feasibility study with nine symptomatic women. Directional efficacy and safety were reported, as well as high user satisfaction. During Phase II, Liv Labs will ensure the pessary meets all requirements for pre-clinical design validation. Output will include engineering specifications and drawings; quality system framework; risk assessment; and results for biocompatibility, toxicity, and forces testing. First a controlled, single-use human factors study will be held to confirm safe and accurate device use (Aim 1). Then a single-arm, open label, interventional efficacy study will be conducted at Northwestern University’s Integrated Pelvic Health Program Clinic (Aim 2). The study will enroll 50 women diagnosed with SUI by means of an in-clinic Cough Stress Test. Enrolled patients will participate in an 17-day pad weight test, to confirm device efficacy. Upon completion of evaluative questionnaires, the same participants will then immediately enter a prospective, descriptive study of patient-managed device use for a period of six months (Aim 3). The team at Liv Labs comprises late-career product developers with experience inventing medical devices and software, branded consumer products and services, and technology-enabled, proactive care models for aging in place. The team is closely advised by a panel of practicing urogynecologists and OB/GYNs. The extended development team has collaborated closely with Liv Labs for three years and includes top-tier consultants in engineering, manufacturing, quality systems, clinical testing and regulatory strategy. Once commercialized, the first-ever Soft Spring Continence Pessary will provide millions of women, from all walks of life, a practical, affordable way to self-treat their SUI symptoms and increase their inclination toward fitness.

项目总结/摘要 Liv实验室开发了一种新型的、可重复使用的、自我管理的硅胶阴道栓，用于患者控制的 女性压力性尿失禁（SUI）是一种困扰约2700万美国女性的疾病 年龄超过25岁。与目前市场上的一次性子宫托不同，该专利- 软弹簧子宫托是一个对称的，中空的，有弹性的形式放置在骨盆底上方， 不要像其他有效的装置和外科手术那样扭结尿道，而是轻轻地压缩尿道。 尿道穿过柔软的阴道组织该器械向下压缩到10 mm圆柱体中，以进行施用器辅助 插入和功能集成的手指环，方便手动删除。只包含柔软的，圆形的 表面，弹簧阴道栓可以润滑，适用于阴道萎缩的患者， 使用现有器械时出现疼痛、撕裂或损伤。Liv Labs团队已经完成了 测试，焦点小组，护理人员评估，临床医生的设计审查，以及为期两周的IRB批准的， 对9名有症状的妇女进行了试点可行性研究。报告了定向疗效和安全性，以及 用户满意度高。在第二阶段，Liv Labs将确保子宫托符合临床前的所有要求。 设计确认产出将包括工程规范和图纸;质量体系框架;风险 评估;以及生物相容性、毒性和力测试的结果。首先是一个受控制的一次性人类 将进行因素研究，以确认器械使用的安全性和准确性（目标1）。然后是单臂开放标签 一项干预性疗效研究将在西北大学的综合盆腔健康项目中进行 诊所（目标2）。该研究将招募50名通过门诊咳嗽应激试验诊断为SUI的女性。 入组患者将参加为期17天的垫重量试验，以确认器械有效性。完成后 评估问卷，相同的参与者将立即进入一个前瞻性的，描述性的研究， 患者管理器械使用6个月（目标3）。Liv Labs的团队由职业生涯后期的 产品开发人员，具有发明医疗器械和软件、品牌消费产品和 服务和技术支持的积极主动的养老模式。该小组由一名 由执业泌尿妇科医生和妇产科医生组成的专家小组。扩展的开发团队密切合作， 在Liv Labs工作了三年，包括工程、制造、质量体系 临床试验和监管策略。一旦商业化，有史以来第一个软弹簧子宫托将 为各行各业的数百万妇女提供一种实用、负担得起的自我治疗SUI症状的方法 增加他们的健身倾向。