Intravaginal device for the treatment of pelvic pain and dyspareunia in female cancer survivors

用于治疗女性癌症幸存者盆腔疼痛和性交困难的阴道内装置

• 批准号: 10759026
• 负责人: Carolyn Kreuzkamp
• 金额: $ 39.15万
• 依托单位: CERVU, INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-25 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10759026
• 关键词: 3D Print; Advocate; Affect; Agreement; Anatomy; Articular Range of Motion; Atrophic; Blood flow; Cancer Survivor; Charge; Clinic; Clinical Trials; Coitus; Collaborations; Custom; Development; Device Designs; Devices; Dilator; Dryness; Dyspareunia; Elasticity; Ensure; Exercise; Feedback; Female; Freezing; Frequencies; Functional disorder; Future; Goals; Home; Incidence; Individual Differences; Interview; Knowledge; Legal patent; Life; Malignant Neoplasms; Massage; Mental Health; Modality; Modification; Motor; Musculoskeletal; Operative Surgical Procedures; Pain; Patients; Pelvic Pain; Pelvic floor structure; Pelvis; Performance; Personal Satisfaction; Phase; Physically Challenged; Prevalence; Production; Provider; Quality of life; Radiation therapy; Recommendation; Relaxation; Reporting; Rotation; Safety; Scheme; Sexual Health; Small Business Innovation Research Grant; Specific qualifier value; Speed; Supervision; Survivors; Testing; Therapeutic; Tissues; Vagina; Validation; Visual; Weight; Width; Woman; Work; Wrist; body position; cancer care; cancer survival; cancer therapy; chemotherapy; chronic pelvic pain; compliance behavior; design; design verification; effective therapy; ergonomics; experience; feasibility testing; first-in-human; grasp; improved; innovation; manufacture; manufacturing run; meetings; mobile application; multimodality; pain reduction; physical conditioning; physical therapist; pressure; prototype; remote patient monitoring; response; safety study; side effect; skills; standard of care; trigger point; vibration

Summary: More than half of female cancer survivors will experience chronic pelvic pain and dyspareunia (painful intercourse) due to their cancer treatments. As the number of cancer survivors continues to grow, so too will the number of women in need of effective treatments for this life-altering condition. Pelvic floor physical therapists currently use several different devices during in-clinic and at-home therapy (vaginal dilators, pelvic wands, vibration devices) but these devices are unregulated, lack appropriate ergonomics, and do not consider comprehensive functionality, patient-specific needs, and the physical challenges common to cancer survivors. Survivors seek an effective multimodal solution that also provides them with the knowledge, skills, and confidence to advocate for their own sexual health. Cervu, Inc. is developing a patent-pending intravaginal device for the highly individualized needs of female cancer survivors that is uniquely designed for dilation, vibration, myofascial release, and trigger point massage therapies. To date, prototype form factor designs have been 3D printed and mailed to patients and providers through multiple rounds of user testing, resulting in down-selection to a candidate design for further development. The objective of this Phase 1 SBIR proposal is to confirm feasibility of function within the confines of the candidate form factor, and to acquire further user feedback prior to design freeze for first-in-human studies. Aim 1. Develop and validate a functional alpha prototype. We will collaborate with design and manufacturing partners to (1) resolve remaining design questions such as selecting appropriate materials, specifying eccentric rotating mass vibration motor and electrical components, and finalizing the handle-dilator attachment mechanism; (2) manufacture a minimum viable product; and (3) validate function agreement with specifications through extensive bench testing. Goals: (1) Device meets form and function specifications including handle and dilator size and curvature tolerance, handle pitch and roll range of motion, vibration frequency, charging speed, visual indicators, dilator durometer, handle attachment/detachment force, weight distribution, and quality consistency; (2) Production of 5 alpha prototypes that meet or exceed specifications. Aim 2. Demonstrate ability of alpha prototype to meet user needs. We will validate design form agreement through formative user testing in 10 total subjects including pelvic floor physical therapists and female cancer survivors with dyspareunia. Subjects will receive prototypes and will be interviewed on the specific device features as well as anticipated ability to perform therapy. Goal: More than 80% of users rate each feature ≥ 3 on a 5-point Likert scale. The proposed work is expected to demonstrate that a functional device can be implemented within a form factor that ensures user acceptance. Impact: This device has the potential to transform dyspareunia treatment, one of the most common conditions affecting quality of life in female cancer survivors.

摘要：超过一半的女性癌症存活率会遭受慢性骨盆疼痛和性交（疼痛）（疼痛） 性交）由于其癌症治疗。随着癌症存活数量的持续增长， 需要有效治疗这种改变生活的妇女的数量。骨盆底物理治疗师 目前在临床和家庭疗法期间使用几种不同的设备（阴道扩张器，骨盆棒， 振动设备）但是这些设备不受监管，缺乏适当的人体工程学，并且不考虑 综合功能，特定于患者的需求以及癌症生存常见的身体挑战。 幸存者寻求有效的多模式解决方案，还为他们提供知识，技能和 有信心提倡自己的性健康。 Cervu，Inc。正在开发一种申请专利的静脉内装置 对于针对字典，振动而设计的女性癌症生存的高度个性化需求， 肌筋膜释放和触发点按摩疗法。迄今为止，原型形式设计为3D 通过多轮用户测试向患者和提供者邮寄给患者和提供者，导致下调 进行进一步发展的候选设计。该阶段1 SBIR提案的目的是确认可行性 在候选形式的范围内的功能，并在设计之前获得更多用户反馈 冻结以进行首次人类研究。 AIM 1。开发和验证功能性α原型。我们将 与设计和制造合作伙伴合作（1）解决剩余的设计问题，例如选择 适当的材料，指定偏心旋转的质量振动电机和电气组件，以及 最终确定手柄丝固定机制； （2）生产最低可行的产品； （3）验证 通过广泛的基准测试与规格的功能一致。目标：（1）设备符合形式和 功能规格，包括手柄和扩张器尺寸以及弯曲耐受性，手柄的音高和滚动范围 运动，振动频率，充电速度，视觉指示器，扩张器持续时间，手柄附件/脱离 力，体重分布和质量一致性； （2）生产5个符合或超过的α原型 规格。 AIM 2。展示Alpha原型满足用户需求的能力。我们将验证设计 通过在包括骨盆底物理治疗师在内的10个受试者中的成型用户测试形成协议 女性癌症患有肌食困难。受试者将收到原型，并将接受特定的采访 设备功能以及进行治疗的预期能力。目标：超过80％的用户对每个功能进行评分 5点李克特量表上≥3。预计拟议的工作将证明功能设备可以是 在确保用户接受的外形范围内实施。影响：此设备有可能 转化肿瘤治疗，这是影响女性癌症生活质量的最常见疾病之一 幸存者。