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.

项目摘要/摘要 LIV实验室已经开发出一种新型的、可重复使用的自我给药硅胶避孕套，用于患者控制的 女性压力性尿失禁(SUI)，这是一种困扰约2700万美国女性的疾病 年龄在25岁以上。与当今市场上可用的贴身和一次性内裤不同，这项专利- Pending Soft Spring Continence Pessary是一种对称的、中空的、有弹性的形式，放置在盆底上方-- 不是像其他有效的装置和外科手术那样扭曲尿路，而是轻轻地按压 通过柔软的阴道组织。该装置被压缩成一个10毫米的圆柱体，以供涂抹器辅助 插入，并具有一个集成的指环，便于手动拆卸。只由柔软的，圆润的 表面，弹簧套筒可以润滑，专为有时患有阴道萎缩的患者而设计 体验现有设备的疼痛、割伤或受伤。Liv Labs团队已经完成了替补 测试、焦点小组、护理者评估、与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。报道了定向疗效和安全性，以及 用户满意度高。在第二阶段，Liv实验室将确保避孕套满足临床前的所有要求 设计验证。输出将包括工程规范和图纸；质量体系框架；风险 评估；以及生物兼容性、毒性和力量测试的结果。首先是一个受控制的，单一用途的人类 将进行因素研究，以确认安全和准确的设备使用(目标1)。然后是一个单臂，开放的标签， 干预效果研究将在西北大学综合盆腔健康项目进行 诊所(目标2)。这项研究将招募50名通过门诊咳嗽压力测试确诊为SUI的女性。 入选的患者将参加为期17天的垫子重量测试，以确认设备的有效性。在完成后 评估性问卷，相同的参与者将立即进入前瞻性的描述性研究 使用患者管理的设备6个月(目标3)。Liv Labs的团队包括职业生涯后期 具有发明医疗设备和软件、品牌消费产品和 服务，以及支持技术的、积极主动的老龄化护理模式。该团队由一位 执业妇科医生和妇产科医生小组。扩展后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、 临床测试和监管策略。一旦商业化，有史以来第一个柔软的春天大陆女装将 为来自各行各业的数百万女性提供一种实用、负担得起的自我治疗SUI症状的方法 并增加他们的健身倾向。