Effectivenss of a New Non-Invasive Erectile Support System in Aging Populations

新型非侵入性勃起支持系统对老年人群的有效性

• 批准号: 8202535
• 负责人: S Alexander Weinstock
• 金额: $ 12.15万
• 依托单位: CONDAX, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8202535
• 关键词: Adverse effects; Age; Aging; Air; American; Appearance; Area; Attention; Blood Pressure; Chemicals; Chest Pain; Clinical Trials; Coitus; Couples; Devices; Diagnosis; Discipline of obstetrics; Effectiveness; Ejaculation; Elements; Erectile dysfunction; Feeling; Focus Groups; General Population; Health; Heterosexuals; Home environment; Impotence; Incidence; Individual; Infusion procedures; Injection of therapeutic agent; Interview; Legal patent; Life Cycle Stages; Liquid substance; Love; Marriage; Measures; Mechanics; Menopause; Mental Depression; Motion; Nature; Nitrates; Occupations; Outcome; Participant; Penile Prosthesis; Pharmaceutical Preparations; Phase; Physical Examination; Physics; Physiological; Physiology; Population; Protocols documentation; Psychologist; Quality of life; Questionnaires; Reporting; Research; Research Design; Research Personnel; Research Proposals; Resort; Role; Sex Functioning; Sexually Transmitted Diseases; Signal Transduction; Social isolation; Solutions; Specialist; Sphygmomanometers; Support System; System; Techniques; Technology; Testing; Tissues; United States National Institutes of Health; United States Social Security Administration; Urologist; Vacuum; Vagina; Voice; Woman; age effect; age group; aging population; condoms; cost; design; elastomeric; erection; experience; male; member; men; new technology; older men; penis; pill; pleasure; prevent; psychologic; satisfaction; sex; sexual relationship; success; tadalafil; tool; vardenafil

DESCRIPTION (provided by applicant): As a normal consequence of aging, most men experience some form of erectile dysfunction (ED), which, in severe cases, causes impotence (the inability to sustain an erection sufficient to engage and complete vaginal intercourse). Conservative estimates place the incidence of all forms of ED in the general population at 30 million cases; the percentage in the aging population, specifically in men over 50, is as high as 50%. This unfortunate but totally natural condition contributes to feelings of insecurity, depression, abandoning relationships, social isolation, and the diminishment of the quality-of-life for both men and their partners. The ancillary negative psychological effects on earning potential and job stability are unknown but suspected to be significant. Solutions include: Over-the-counter chemical remedies, mechanical vacuum devices, still controversial prescribed pills, and more invasive treatments including, transurethral inserts, penile injections, and penile implants. Although these have varying inter/intra-use success, none are universally acceptable, none include protection against sexually transmitted infections, none offer nearly spontaneous use. These circumstances and a maturing populace signal the need for new technology. METHODS: Fifty, mature, heterosexual couples (ages 50-75), demographically selected from diagnosed populations of moderate and severe erectile dysfunction, will participate in 250 at-home clinical trials using a new, non-invasive', air-infused', erectile support system, able to be used throughout intercourse and designed, using scaled-down elements of the sphygmomanometer, to gently and non-ischemically compress ambient fluids permitting the then flaccid or semi-flaccid penis to harden sufficiently for intercourse. Comparisons will be made to a small group reporting no erectile dysfunction. Highly experienced investigators, including Urologists and Obstetrics specialists, will conduct the research protocol using physical examinations, previously validated questionnaires, and participant interview techniques. Prior to the clinical trials, focus groups will be used to modify the questionnaires and research design to fit the specific concerns voiced by the target age group. The questionnaires will measure, comfort, ease of use, and satisfaction. AIMS: The objective of this research proposal is a feasibility test of the effectiveness and safe- functioning of the new technology and to determine the ability of the new device-system to assist and permit men suffering from the effects of ED or impotence and their partners to participate in satisfactory sexual relations. The low projected cost ($5.00) and 'instant use when needed', non- invasive, nature of the new 'I-Rect"' device-system should help make it a commercial success. PUBLIC HEALTH RELEVANCE: The fact that so much National attention is being placed on the solvency of the Social Security Administration reflects the fact that during the next thirty years the number of retired, hence over 62 year old individuals will triple from the current roles and underscores the consequential effects that aging will have in all areas of American life and, of course, on sexual functioning. This research investigates a Patented means of allowing men and their partners to continue to enjoy near- normal sexual relationships despite the natural diminishment of erectile functioning that ordinarily is a component of aging without resorting to chemical prescriptions that can alter blood pressure or other invasive techniques and devices that erode and interrupt natural love-making activities as practices by harmonious couples. The research also compares and contrasts this New I-RECT System to conventionally packaged condoms alone to establish the feasibility in function and the measure the satisfaction achieved as reported by both partners after private at-home use.

描述（由申请人提供）：作为衰老的正常结果，大多数男性都会经历某种形式的勃起功能障碍（ED），在严重的情况下，会导致阳痿（无法维持足以进行和完成阴道性交的勃起）。保守估计，普通人群中所有形式的 ED 发病率达 3000 万例；老龄化人口的比例，特别是50岁以上的男性，高达50%。这种不幸但完全自然的状况会导致男性及其伴侣的不安全感、抑郁、放弃人际关系、社会孤立以及生活质量下降。对收入潜力和工作稳定性的附带负面心理影响尚不清楚，但怀疑是显着的。解决方案包括：非处方化学疗法、机械真空装置、仍有争议的处方药以及更具侵入性的治疗方法，包括经尿道插入、阴茎注射和阴茎植入。尽管这些药物之间/内部使用取得了不同的成功，但没有一个被普遍接受，没有一个包括针对性传播感染的保护，没有一个几乎可以自发使用。这些情况和人口的成熟表明对新技术的需求。 方法：从诊断为中度和重度勃起功能障碍的人群中选择 50 对成熟异性恋夫妇（50-75 岁），参加 250 项家庭临床试验，使用一种新的、非侵入性的“空气注入”、勃起支持系统，能够在整个性交过程中使用，并使用血压计的按比例缩小的元件进行设计，以温和且非局部化学方式压缩周围液体，从而允许勃起松弛或半松弛的阴茎足以硬化以进行性交。将与报告没有勃起功能障碍的小组进行比较。包括泌尿科医生和产科专家在内的经验丰富的研究人员将使用体检、先前验证的问卷和参与者访谈技术来执行研究方案。在临床试验之前，焦点小组将用于修改调查问卷和研究设计，以适应目标年龄组提出的具体问题。调查问卷将衡量舒适度、易用性和满意度。 目的：本研究提案的目的是对新技术的有效性和安全功能进行可行性测试，并确定新设备系统帮助和允许患有 ED 或阳痿影响的男性及其伴侣的能力参与满意的性关系。新型“I-Rect”设备系统的预计成本较低（5.00 美元）和“需要时立即使用”、非侵入性的特性应有助于使其取得商业成功。 公共卫生相关性：国家对社会保障管理局的偿付能力给予如此多的关注这一事实反映了这样一个事实：在未来三十年中，退休人员（即 62 岁以上）的人数将是目前角色的三倍，并强调老龄化将对美国人生活的各个领域产生间接影响，当然还有性功能。这项研究调查了一种专利方法，该方法允许男性及其伴侣继续享受近乎正常的性关系，尽管勃起功能自然减弱（通常是衰老的一个组成部分），而无需诉诸可改变血压的化学处方或其他侵入性技术，并且侵蚀和中断和谐夫妻的自然做爱活动的装置。该研究还将这种新的 I-RECT 系统与传统包装的避孕套进行了比较和对比，以确定功能的可行性，并衡量双方在私人家庭使用后所报告的满意度。