Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina B

神经重新布线治疗 B 型脊柱神经源性膀胱的安全性和有效性

基本信息

批准号：
7696321
负责人：
KENNETH M PETERS
金额：
$ 47.2万
依托单位：
WILLIAM BEAUMONT HOSPITAL RESEARCH INST
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2014-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7696321
关键词：
Adverse effects Adverse event Affect Anatomy Applications Grants Area Axon Benefits and Risks Bladder Bladder Control Bladder Dysfunction Brain Catheterization Catheters Child China Clinical Clinical Trials Complement Congenital Abnormality Cutaneous Data Dependency Devices Dialysis procedure Effectiveness Electric Stimulation Electrodes Foundations Frequencies Functional Magnetic Resonance Imaging Functional disorder Future Genetic Crossing Over Health Horseradish Peroxidase Individual Institution Intestines Kidney Kidney Transplantation Left Life Location Lower Extremity Lumbar spinal nerve root structure Manuals Mechanical Stimulation Mechanics Medical Micturition Reflex Mission Motor Motor Neurons Muscle function Natural regeneration Nerve Neuraxis Neurogenic Bladder Numbness Operative Surgical Procedures Organ Outcome Participant Pathway interactions Patients Pelvis Pharmaceutical Preparations Pilot Projects Play Principal Investigator Procedures Published Comment Quality of life Rattus Reflex action Reporting Research Research Design Role Sacral nerve Safety Sex Functioning Sexual Dysfunction Site Skin Smooth Muscle Solutions Spinal Cord Spinal Dysraphism Spinal cord injury Spinal nerve root structure Structure of parasympathetic ganglion Study Subject TNFRSF5 gene Techniques Testing Transcutaneous Electric Nerve Stimulation Translational Research Urethral sphincter Urination Urology Ventral Roots Visceral Waiting Lists Work autonomic reflex base enema administration experience follow-up ganglion cell improved improved functioning insight interest novel pilot trial pressure programs public health relevance relating to nervous system response social somatic reflex spinal nerve posterior root success urinary tract pressure

项目摘要

DESCRIPTION (provided by applicant): Spina Bifida, a congenital defect of the spinal cord, causes nerve damage and a loss of sensation and muscle function below the waist resulting in bowel, bladder and sexual dysfunction. Patients cannot urinate or are constantly wet, and this continues throughout life causing major quality of life and health problems. Clean intermittent catheterization is usually needed to empty the bladder properly. Antimuscarinic medications are commonly required to alleviate high urinary tract pressures that can cause irreversible kidney damage, where dialysis or kidney transplant is the only way to sustain life. Dr. Xiao developed and is performing a novel procedure in China that connects a functioning, healthy lumbar spinal nerve root to the sacral nerve that controls the bladder. The end result is the creation of a new reflex where the bladder can be emptied by scratching or stimulating the skin supplied by that spinal nerve root. He has reported that in 92 SCI patients, 88% regained bladder control within one year after the nerve rerouting surgery and in 110 children with spina bifida, reported success in 87% at one year. However, in China rigorous follow up is challenging, therefore much is still unknown about the neurorecovery post surgery, complications and results occurring in the first year in particular, and the potential role that central nervous system remodeling may play in achieving successful outcomes. At Beaumont, a pilot study is underway on 9 spina bifida subjects, however no other center in the US is currently studying this technique. Our preliminary data are very promising, and with 9 subjects now 12 months post procedure, 7/9 subjects are voiding either voluntarily or by stimulating the new reflex mechanism. This project aims to expand upon our pilot experience to conduct a larger and more rigorous study to establish the safety and effectiveness of the proposed somatic-autonomic reflex pathway procedure in gaining bladder and bowel control in patients with spina bifida. Additionally, we will systemically evaluate and optimize frequency and location for excitation of the new somatic-autonomic reflex arc to a) gain more insight into the neurorecovery associated with nerve rerouting, and b) scientifically and systematically determine the ideal stimulation parameters to achieve best voiding results and make the somatic-autonomic reflex pathway rerouting most useful for the patients. Achieving the aims outlined in this proposal will help firmly establish the procedure as safe and effective, and revolutionize the treatment of bladder and bowel dysfunction in patients with spina bifida. PUBLIC HEALTH RELEVANCE: Spina Bifida, a congenital defect of the spinal cord, causes nerve damage resulting in bowel, bladder and sexual dysfunction. Dr. Xiao, in China, developed a new procedure to rewire the nerves affecting the bladder, and this project aims to scientifically establish the safety and effectiveness of the surgical procedure.

描述（由申请人提供）：脊柱裂，脊髓的先天性缺陷，导致神经损伤，腰部低于腰部的感觉和肌肉功能丧失，导致肠，膀胱和性功能障碍。患者不能小便或不断湿，这在整个生命中持续导致重大的生活和健康问题。通常需要清洁间歇性导管插入术才能正确清空膀胱。通常需要进行抗毒性药物来减轻可能造成不可逆转的肾脏损害的高尿路压力，透析或肾脏移植是维持生命的唯一方法。 Xiao博士在中国开发并正在进行一种新的程序，该程序将功能功能，健康的腰椎根部与控制膀胱的s骨神经联系起来。最终结果是创建一种新的反射，可以通过刮擦或刺激该脊神经根提供的皮肤来清空膀胱。他报告说，在神经重新布局手术后的一年内，有92名SCI患者在92例SCI患者中恢复了膀胱控制，110名脊柱裂儿童在一年中的成功率为87％。但是，在中国，严格的随访是具有挑战性的，因此，尤其是第一年的神经记录，并发症和结果以及中枢神经系统重塑可能在取得成功的结果中发挥的潜在作用，仍然尚不清楚。在博蒙特（Beaumont），一项针对9个脊柱裂的受试者正在进行的试点研究，但是美国目前没有其他中心正在研究这项技术。我们的初步数据非常有前途，并且在手术后12个月内有9个受试者，7/9受试者自愿或通过刺激新的反射机制而无效。该项目旨在扩大我们的试点经验，以进行更大，更严格的研究，以确立拟议的脊柱裂菌患者在获得膀胱和肠道控制方面提议的躯体自主反射途径程序的安全性和有效性。此外，我们将系统地评估和优化频率和位置，以激发新的体细胞自主反射弧，以a）更深入地了解与神经改革相关的神经回报，b）科学和系统地确定理想的刺激参数，以实现良好的体现效果，并使体育型反射式途径成为最大的患者，以使其对大多数患者有用。实现本提案中概述的目标将有助于牢固地确定该程序是安全有效的，并彻底改变了脊柱裂的患者的膀胱和肠功能障碍的治疗。公共卫生相关性：脊柱脊柱是脊髓的先天性缺陷，会导致神经损伤，导致肠，膀胱和性功能障碍。中国的Xiao博士开发了一种新的程序来重新连接影响膀胱的神经，该项目旨在科学地确定手术程序的安全性和有效性。