Wireless Tibial Nerve Stimulation Therapy for Overactive Bladder

描述（由申请人提供）：本SBIR第一阶段提案的目标是确定无线神经调节控制膀胱功能的可行性。在美国和欧洲，大约16.5%的成年人患有膀胱过动症（OAB）。经皮电刺激胫后神经（PTN）最近被认为是一种有效且微创的替代方法，可以替代失败的传统行为改变药物治疗和更具侵入性的手术方法。这种疗法作为Urgent PC(R)系统（Uroplasty, Inc ., Minnetonka， MN）在商业上可用。然而，为了实现和维持Urgent PC的临床效益，反复的办公室访问被证明是使用该产品的一大障碍。因此，虽然刺激PTN仍然是治疗未治疗OAB患者的首要目标，但缺乏临床可接受和实用的治疗方法。结果，数百万患者得不到治疗。该项目的长期目标是通过为OAB患者提供一种根据需要在自己家中治疗自己的方法，从而恢复OAB患者的生活质量。这种方法将克服紧急PC治疗的主要弱点。Rossellini Scientific正在与Stimwave Technologies合作，将他们的无线植入技术应用于适合PTN电刺激的外形因素和治疗方案。在这个第一阶段的提案中，我们的第一个具体目标是测试使用我们的无线神经刺激器反射性抑制膀胱的可行性，从而增加膀胱容量

DESCRIPTION (provided by applicant): The goal of this SBIR Phase 1 proposal is to determine the feasibility of wireless neuromodulation for controlling bladder function. Overactive bladder (OAB) affects about 16.5% of the adult population in both the United States and Europe. Percutaneous electrical stimulation of the posterior tibial nerve (PTN) recently emerged as an effective, yet minimally invasive alternative to failed conventional behavioral modifications drug treatments, and more invasive surgical approaches. This therapy is commercially available as the Urgent PC(R) system (Uroplasty, Inc, Minnetonka, MN). However, the repeated office visits needed to achieve and sustain the clinical benefits of Urgent PC proves to be a great impediment to the use of this product. Thus, while stimulation of the PTN remains a top target for reaching the untreated sufferers of OAB, a clinically acceptable and practical method of implementing this treatment is lacking. As a result millions of patients remain untreated. The long-term goal of this project is to restore quality of life to those suffering with OAB by providig patients with a means of treating themselves in their own home as needed. This approach will overcome the primary weakness of the Urgent PC therapy. Rossellini Scientific is partnering with Stimwave Technologies to apply their wireless implant technology to a form factor and therapeutic treatment protocol appropriate for electrical PTN stimulation. In this Phase 1 proposal, our first specific aim is to test the feasibility of using our wirelessly powered nerve stimulator to reflexively inhibit the urinary bladder - and hence increase bladder capacity - in an acute animal model. We plan to expand our preliminary data that showed electrical nerve stimulation using a voltage-controlled capacitive discharge (VCCD) waveform requires less charge per pulse than traditional constant-current (CC) stimulation. We will determine whether VCCD or CC stimulation is most appropriate for electrically modulating bladder function. We will also determine target stimulation parameters for wireless neuromodulation of bladder function to be used in planned clinical trials. The second specific aim is to test the chronic performance of the implant in animals to ensure stability of device function. To conclude that our device and approach are feasible, we must observe at least a 30% decrease in bladder pressure (induce relaxation), and that bladder volume is increased by e 50% under the conditions of this study. We must also find that our device effectively stimulates following 4, 8, and 12 weeks of implantation. If our device is effective in these models, then we will apply to the NIH for Phase 2 funding to carry out a clinical trial to test safety, efficacy, and patient compliance.