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

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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.