Peripheral Nerve Stimulation for Bladder Emptying

描述(由申请人提供)：超过20万患有脊髓损伤(SCI)的美国人不能自愿控制他们的下尿路，他们有健康问题和生活质量下降。目前，一种使用电刺激骶神经根来恢复膀胱排空的产品(VOCARE，Finetech Medical，UK)已经上市，但它并未被潜在患者广泛接受，因为它涉及侵入性外科手术，需要永久切断传入神经。该项目的长期目标是开发一种侵入性更小、不需要神经横断的替代神经刺激产品并将其商业化。这一第一阶段方案的具体目的是证明通过电刺激阴部神经(PN)的尿路传入通路在脊髓损伤患者中引发膀胱收缩以排出储存的尿液的可行性。假设PN传入刺激将激活脊髓反射，使膀胱以较低的残留量排空，而不需要切断传入神经。这一假设将在患有脊髓损伤的人类身上得到验证，方法是用微创导管-电极技术刺激PN传入神经，并测量1)刺激引起的膀胱压力和2)刺激前后的膀胱容量。在第一阶段项目结束时，我们将确定通过电刺激脊髓损伤患者的PN传入排空膀胱的可行性。

DESCRIPTION (provided by applicant): Over 200,000 Americans with spinal cord injury (SCI), who cannot voluntarily control their lower urinary tract, have health problems and a decreased quality of life. Presently, one product using electrical stimulation applied to the sacral nerve roots to restore bladder emptying (VOCARE, Finetech Medical, UK) is commercially available, but it is not widely accepted among the potential patient population because it involves an invasive surgical procedure and requires permanently severing afferent nerves. The long-term goal of this project is to develop and commercialize a less invasive alternative neurostimulation product that does not require nerve transection. The specific aim of this Phase I proposal is to demonstrate the feasibility of eliciting bladder contractions to expel stored urine by electrical stimulation of urethral afferent pathways in the pudendal nerve (PN) in persons with SCI. The hypothesis is that PN afferent stimulation will activate a spinal reflex enabling bladder emptying with low residual volumes without requiring the transection of afferent nerves. This hypothesis will be tested in humans with SCI by stimulating PN afferents with a minimally invasive catheter-electrode technique and measuring 1) bladder pressure evoked by stimulation and 2) bladder volume before and after stimulation. At the conclusion of this Phase I project, we will have determined the feasibility of emptying the bladder by electrical stimulation of the PN afferents in persons with SCI.