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.
Public Health Relevance Statement: Public Health Relevance: Overactive bladder (OAB) affects approximately 34 million Americans. It is a devastating condition that impairs mobility, leads to social isolation, disturbe sleep, impaired domestic functionality, diminished sexual performance, and reduction in the ability to live independently. Due to lack of treatment options, less than half of the patients wit this condition actually receive effective treatment. This is a proposal to develop a neuromodulation treatment for this unreached patient population.
Project Terms: Acute; Adult; Affect; American; Animal Model; Animals; base; Behavior Therapy; Bladder; Bladder Control; Charge; Chronic; chronic back pain; chronic pain; Clinical; Clinical Trials; Compliance behavior; conventional therapy; Data; design; Devices; effective therapy; Electric Stimulation; Ensure; Europe; Felis catus; foot; Frequencies (time pattern); Funding; Goals; Home environment; Human; Implant; implantation; Incontinence; Life; Maintenance; Marketing; Methods; minimally invasive; Modality; Modeling; Nerve; Nerve Fibers; neuroregulation; Neurostimulation procedures of spinal cord tissue; Office Visits; Operative Surgical Procedures; Overactive Bladder; Pain in lower limb; patient population; Patients; Performance; Pharmaceutical Preparations; Phase; Physiologic pulse; Population; Posterior Tibial Nerves; pressure; public health relevance; Quality of life; Rattus; Recruitment Activity; Relaxation; Reporting; response; safety testing; Sleep; Small Business Innovation Research Grant; Social isolation; Structure of tibial nerve; Symptoms; System; Technology; Testing; Therapeutic; Treatment outcome; Treatment Protocols; United States; United States National Institutes of Health; Visit; voltage; Wireless Technology; Wit
