Surgical Trial of a Somatic to Autonomic Intradural Nerve Anastomosis (Xiao Procedure) in Children with Neurogenic Bladder Undergoing Spinal Cord Detethering: A Randomized, Prospective, Double Blinded Study.
YVES HOMSY, MD, FRCSC, FAAP1, Gerald Tuite, MD1, Ethan Polsky, MD1, Margaret Reilly, PT2, Parrish Winesett, MD1, Carolyn Carey, MD1, Luis Rodriguez, MD1, Sarah Gaskill, MD1, Bruce Storrs, MD1, Denise Martinez, M.Sc.2, Lisa Tetreault, RN3.
1Johns Hopkins All Children's Hospital and University of South Florida, Tampa/St Petersburg, FL, USA, 2Johns Hopkins All Children's Hospital, St Petersburg, FL, USA, 3Johns Hopkins All Children's Hospital, Tampa/St Petersburg, FL, USA.
BACKGROUND: Xiao et al. have studied an intradural somatic to autonomic (ex: proximal stump of ventral L5 to distal stump of S3/4) nerve root transfer while keeping the dorsal root intact as a method to create a reflex arc to allow bladder emptying in response to cutaneous stimulation. Xiao et al. and other investigators have reported a 67% to 86% success rate after the Xiao procedure, believed to be the result of the establishment of a "skin-CNS-bladder" reflex arc to allow spontaneous, controlled voiding. However, these studies have not included a control group. Many of the parameters used to define the success of the operation were qualitative and subjective. We designed our study to more rigorously analyze this novel procedure which has generated great enthusiasm and would potentially allow patients with neurogenic bladders to control their volitional voiding.
METHODS: The investigators traveled to China to learn the surgical technique, its indications and the postoperative management from Professor Xiao. As of 3/2009, 20 children with spina bifida who were scheduled for spinal cord detethering for the usual indications.
were enrolled in a randomized, prospective, double blinded trial. Patients were randomized between two arms at the time of detethering: half of the patients underwent a standard detethering procedure, while the other half underwent detethering plus the Xiao procedure. Patients, families, and health care providers were all blinded to the treatment arm. We analyzed motor and sensory function, activities of daily living and bladder function before surgery and at 3, 6, 9, 12, 24 and 36 months after surgery using extensive questionnaires, physical examinations and detailed urodynamic studies.RESULTS: 10/20 patients underwent only spinal cord detethering and the other 10 underwent the Xiao procedure plus standard spinal cord detethering. All patients completed the 3-year follow-up evaluation. Results of over 1,000 clinical outcome data points per patient were analyzed and summarized, comparing patients in both groups. No child in either group had a reproducible, reliable and useful ability to initiate normal voiding at their three-year follow-up.CONCLUSIONS: This rigorous evaluation of the Xiao procedure failed to produce reliable and reproducible improvements in bladder function or voluntary voiding in children with spina bifida when compared to patients who underwent a standard spinal cord detethering procedure.
Source of Funding: All Children's Hospital Foundation.American Association of Neurological Surgeons/Congress of Neurological Surgeons Joint Section of Pediatric Neurological Surgery.
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