Peripheral Nerve Stimulation for Erectile Restoration

描述(申请人提供)：近4600万美国人患有勃起功能障碍(ED)，40岁至70岁的所有男性中约有35%至50%患有某种形式的勃起功能障碍。目前的勃起功能障碍的治疗方法通常在1到3年内因疗效丧失、副作用或勃起组织的永久性损伤而被患者拒绝。勃起是通过电刺激动物的周围神经产生的，预计不会失去疗效，也不会引起与现有疗法相关的副作用或不可逆转的损害。该项目的长期目标是开发一种神经刺激产品并将其商业化，该产品将电刺激周围神经，使患有血管性勃起功能障碍的男性产生勃起。该项目将确定在急性动物模型中使用放置在骨盆中靠近周围神经的电极导线来实现持续勃起的可行性。这个第一阶段项目的前两个具体目标是确定使用电刺激周围神经来1)唤醒和2)维持与阴茎海绵体内注射前列地尔(临床治疗疗效的黄金标准)相当的阴茎勃起的可行性。假设电刺激周围神经将1)诱发和2)维持阴茎勃起，刺激持续时间长达30分钟，周围神经刺激引起的阴茎海绵体压力(CCP)将大于或等于前列地尔引起的CCP。第三个具体目标是在动物模型中验证一种技术，如果特定目标#1和#2成功，该技术可用于将这些结果转化为人类。3)在动物模型中，经皮电刺激将通过放置在骨盆内的微创双接触电极诱导和维持勃起，经皮刺激诱发的CCP将大于或等于前列地尔诱发的CCP。在本项目结束时，我们将确定通过电刺激周围神经来唤起和维持勃起的可行性，这与动物模型中的临床黄金标准相当。如果确定可行，这种方法将被开发成一种不会引起目前ED疗法的副作用或损害的微创神经假体。在4600万患有勃起功能障碍的美国人中，超过70%的人报告说，他们的生活质量受到勃起功能障碍的中度到严重影响，超过70%的患有勃起功能障碍的男性感到他们的伴侣对他们的勃起功能障碍的反应感到伤害。在某种程度上是失败的？因为他们的爱德。因此，勃起功能障碍通常与自我形象不佳、抑郁有关，它会影响人际关系，导致精神压力增加。我们建议开发一种治疗ED的微创疗法，这种疗法不会引起现有ED疗法的副作用或损害。

DESCRIPTION (provided by applicant): Nearly 46 million Americans have erectile dysfunction (ED), and approximately 35% to 50% of all men aged 40 to 70 have some form of ED. Present therapies for ED are often rejected by patients within 1 to 3 years due to loss of efficacy, side effects, or permanent damage to erectile tissue. Erection has been generated by electrical stimulation of a peripheral nerve in animals and is not expected to lose efficacy or cause the side effects or irreversible damage associated with present therapies. The long-term goal of this project is to develop and commercialize a neurostimulation product that would electrically stimulate the peripheral nerve to generate erection in men with vasculogenic erectile dysfunction. The project will determine the feasibility of using an electrode lead placed in the pelvis near the peripheral nerve to achieve a sustained erection in the acute animal model. The first two specific aims of this Phase I project are to determine the feasibility of using electrical stimulation of the peripheral nerve to 1) evoke and 2) sustain a penile erection that is comparable to intracavernous injection of alprostadil (the gold standard for clinical treatment efficacy) in cats. The hypotheses are that electrical stimulation of the peripheral nerve will 1) elicit and 2) sustain a penile erection that is sustained for the duration of stimulation up to 30 minutes, and the corpus cavernous pressure (CCP) evoked by peripheral nerve stimulation will be greater than or equal to the CCP evoked by alprostadil. The third specific aim is to 3) validate in the animal model a technique that can later be used to translate these results to humans if specific aims # 1 and # 2 are successful. The hypothesis is that 3) in the animal model, percutaneous electrical stimulation will elicit and sustain an erection through a minimally invasive two- contact electrode placed in the pelvis, and the CCP evoked by percutaneous stimulation will be greater than or equal to the CCP evoked by alprostadil. At the conclusion of this project, we will have determined the feasibility of evoking and sustaining an erection via electrical stimulation of the peripheral nerve that is comparable to the clinical gold standard in the animal model. If it is determined to be feasible, this approach will be developed into a minimally invasive neural prosthesis that does not cause the side effects or damage caused by present ED therapies. Over 70% of the 46 million Americans with erectile dysfunction (ED) report that their quality of life is moderately to severely reduced by ED, and over 70% of men with ED feel hurt by the response of their partner to their ED and feel ? to some extent a failure? because of their ED. Thus, ED is often associated with poor self- image, depression, and it can affect interpersonal relationships and lead to increased mental stress. We propose to develop a minimally invasive treatment for ED that does not cause the side effects or damage caused by current ED therapies.