SBIR Phase II: A mesh-free, sling-free, minimally invasive treatment for stress urinary incontinence in women

该小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力是一种用于治疗女性压力性尿失禁（SUI）的新型手术植入器械。近50%的美国女性将随着年龄的增长而患有压力性尿失禁，到2050年将有超过4000万女性患有压力性尿失禁。目前没有药物解决方案，基于网片的尿道中段悬吊术（MUS）是主要的手术选择，尽管它们与各种长期并发症、挑战和风险相关。此外，市场上的所有SUI修补产品都是基于聚丙烯网的，没有替代品。该项目旨在通过无网片、无吊带、门诊女性尿失禁经阴道修复装置来解决这一问题。该小型企业创新研究（SBIR）二期项目旨在开发和验证一种新型经阴道手术技术，用于治疗压力性尿失禁。该项目推进了SBIR第I阶段项目的发现，该项目证明了功能概念验证生物力学可行性。该第二阶段项目旨在以适合人类使用的方式进一步推进外科手术和系统。技术活动的范围包括设计优化、机械测试和确认、外科手术确认、生物相容性测试以及一系列台架、尸体和动物研究中的组织学表征。活动的范围将按照在临床前模型中证明慢性植入安全性和有效性所需的实践进行，以获得最终的美国监管批准。该奖项反映了NSF的法定使命，并被认为值得通过使用基金会的知识价值和更广泛的影响审查标准进行评估来支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel, surgically implanted device for treating female stress urinary incontinence (SUI). Nearly 50% of women in the U.S. will suffer from stress urinary incontinence with age resulting in over 40 million suffering women by 2050. No pharmacological solutions currently exist and mesh-based midurethral slings (MUS) are the mainstay surgical option, even though they are associated with various long-term complications, challenges, and risks. Furthermore, all SUI repair products on the market are polypropylene mesh-based with no alternatives available. This project aims to address this gap in options with a mesh-free, sling-free, outpatient transvaginal repair device for female urinary incontinence.This Small Business Innovation Research (SBIR) Phase II project aims to develop and validate a novel, transvaginal surgical procedural technology for treating stress urinary incontinence. This project progresses findings from the SBIR Phase I project which demonstrated functional proof-of-concept biomechanical feasibility. This Phase II project aims to further the surgical procedure and system in a manner suitable for human use. The scope of technical activities includes design optimization, mechanical testing and validation, surgical procedure validation, biocompatibility testing, and histological characterization in a series of benchtop, cadaveric, and animal studies. The scope of the activities will be conducted in accordance with practices needed to demonstrate chronic implanted safety and efficacy in pre-clinical models in order to gain eventual U.S. regulatory approval.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.