Peripheral Nerve Stimulation for Erectile Restoration

周围神经刺激以恢复勃起

• 批准号: 7153576
• 负责人: Joseph Wilder Boggs
• 金额: $ 17.49万
• 依托单位: NDI MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7153576
• 关键词: electrodes; impotence; lead; model; pelvis

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.

描述（由申请人提供）：近4600万美国人患有勃起功能障碍（艾德），并且年龄在40至70岁的所有男性中约有35%至50%患有某种形式的ED。由于疗效丧失、副作用或对勃起组织的永久性损伤，艾德的现有疗法通常在1至3年内被患者拒绝。勃起已经通过对动物外周神经的电刺激产生，并且预期不会失去功效或引起与当前疗法相关的副作用或不可逆损伤。该项目的长期目标是开发和商业化一种神经刺激产品，该产品将电刺激外周神经，以使血管性勃起功能障碍男性勃起。该项目将确定在急性动物模型中使用放置在骨盆周围神经附近的电极导线以实现持续勃起的可行性。该I期项目的前两个具体目标是确定使用外周神经电刺激1）唤起和2）维持阴茎勃起的可行性，其与猫海绵体内注射阿利地尔（临床治疗有效性的金标准）相当。假设外周神经的电刺激将1）引发和2）维持阴茎勃起，刺激持续时间长达30分钟，外周神经刺激诱发的海绵体压力（CCP）将大于或等于阿曲地尔诱发的CCP。第三个具体目标是3）在动物模型中验证一种技术，如果具体目标1和目标2成功，该技术随后可用于将这些结果转化为人类。假设3）在动物模型中，经皮电刺激将通过放置在骨盆中的微创双触点电极引起并维持勃起，并且经皮刺激诱发的CCP将大于或等于阿鲁地尔诱发的CCP。在本项目结束时，我们将确定通过周围神经的电刺激引起和维持勃起的可行性，这与动物模型中的临床金标准相当。如果确定可行，这种方法将被开发成一种微创神经假体，不会引起目前艾德疗法所引起的副作用或损害。超过70%的46万美国人与勃起功能障碍（艾德）报告说，他们的生活质量是中度至重度降低艾德，超过70%的男性与艾德感到伤害的反应，他们的合作伙伴，他们的艾德和感觉？在某种程度上是失败的。因此，艾德往往与自我形象差、抑郁有关，它会影响人际关系，导致精神压力增加。我们建议开发一种微创治疗艾德，不会引起目前艾德治疗引起的副作用或损害。