Urological Outcome of the Xiao Procedure in Children with Myelomeningocele and Lipomyelomeningocele Undergoing Spinal Cord Detethering.

PURPOSE: Although previous studies have revealed high success rates (70% to 85%) after an intradural somatic-to-autonomic nerve transfer procedure in children with spinal dysraphism, no study has had a control group or blinded observers. We report a rigorously designed study to investigate the effectiveness of the Xiao procedure. MATERIALS AND METHODS: Children with neurogenic bladder dysfunction related to myelomeningocele or lipomyelomeningocele who required spinal cord detethering were randomized to 2 groups at surgery, with half undergoing only spinal cord detethering and half undergoing the Xiao procedure in addition to detethering. Double-blind evaluations were performed at regular intervals during the 3-year followup. RESULTS: A total of 10 patients underwent spinal cord detethering only and 10 underwent detethering plus the Xiao procedure. The Xiao procedure did not result in voluntary voiding or continence in any patient, but patients undergoing spinal cord detethering plus the Xiao procedure were more likely to have greater improvements in total bladder capacity, bladder overactivity and overall quality of life than those who underwent detethering only. By the end of the study no participant or evaluator was able to accurately predict to which group the patients had been assigned. CONCLUSIONS: The results of this randomized controlled trial are in agreement with recently published similarly poor results of the Xiao procedure in patients with spinal cord injury. Improvements in bladder parameters observed in this study may be related to sacral nerve root section, a necessary portion of the Xiao procedure, instead of reinnervation. Confirmatory animal studies are recommended before further clinical trials of the Xiao procedure are performed in humans.

Management of functional constipation in children with lower urinary tract symptoms: report from the Standardization Committee of the International Children's Continence Society.

PURPOSE: We present a consensus view of members of the International Children's Continence Society (ICCS) together with pediatric gastroenterologists, experts in the field of functional gastrointestinal disorders, on the management of functional constipation in children with lower urinary tract symptoms. MATERIALS AND METHODS: Discussions were held by the board of the ICCS and a multidisciplinary core group of authors was appointed. The draft document review process was open to all ICCS members via the website. Feedback was considered by the core authors and, by agreement, amendments were made as necessary. RESULTS: Guidelines on the assessment, and pharmacological and nonpharmacological management of functional constipation in children with lower urinary tract symptoms are outlined. CONCLUSIONS: The final document is not a systematic literature review. It includes relevant research when available, as well as expert opinion on the current understanding of functional constipation in children with lower urinary tract symptoms. The document is intended to be clinically useful in primary, secondary and tertiary care settings.

Phase IIb/III dose ranging study of tamsulosin as treatment for children with neuropathic bladder.

PURPOSE: We evaluated the efficacy and safety of tamsulosin hydrochloride in children with increased detrusor leak point pressure associated with neuropathic bladder. MATERIALS AND METHODS: In a double-blind, randomized, placebo controlled trial patients with detrusor leak point pressure 40 cm H(2)O or greater were stratified by age (2 to less than 5 years, 5 to less than 10 years, 10 to 16 years) and concomitant anticholinergic use, and were randomized to receive various doses of tamsulosin or placebo. A 2-week titration was followed by a 12-week maintenance treatment period. Primary end point was response, ie detrusor leak point pressure less than 40 cm H(2)O from 2 evaluations on the same day at week 14. Secondary end points included detrusor leak point pressure change from baseline, hydronephrosis and hydroureter responses, change in catheterization volumes and adverse events. RESULTS: A total of 161 patients received 1 or more treatment doses between January 2008 and February 2009, and 135 were evaluable for the primary end point. A total of 51 patients (37.8%) were detrusor leak point pressure responders, with no statistically significant difference in response rates between each tamsulosin dose and placebo. Adjusting for stratification variables, mean detrusor leak point pressure changes from baseline to week 14 for placebo and low, medium and high dose groups were -11.4, -17.6, -4.6 and -14.3 cm H(2)O, respectively. In 141 evaluable patients hydroureter/hydronephrosis improvement rates were 7.1% and 5.7% in left and right kidneys (hydroureter), respectively, and 14.9% and 14.2% in left and right kidneys (hydronephrosis), respectively. No group experienced decreases in median post-void residual volume at week 14. Drug related adverse event incidences were 4.9% (placebo) and 5.8% (tamsulosin). CONCLUSIONS: Tamsulosin was well tolerated but not efficacious in this pediatric population with neuropathic bladder.

Treatment of a child with daytime urinary incontinence.

BACKGROUND AND PURPOSE: This case report describes physical therapy management of a child with daytime urinary incontinence, taking into account the patient's age as well as her emotional and cognitive development. CASE DESCRIPTION: An 8-year-old girl was referred for physical therapy with a diagnosis of pelvic floor muscle hypertonus and dysfunctional voiding. Functional deficits included daytime urinary incontinence (4-8 leaks/d, 7 d/wk) and increased voiding frequency (8-10 times/d). Intervention included age appropriate education, biofeedback, behavioral modification and performance of "roll for control" exercises. OUTCOMES: Normal levels of voiding frequency occurred by the third therapy session, and complete recovery of normal function, including daytime continence, occurred by the eleventh therapy session. DISCUSSION: The outcome demonstrates the successful achievement of urinary continence in an 8-year-old child following physical therapy intervention of lower urinary tract rehabilitation.

Lack of efficacy of an intradural somatic-to-autonomic nerve anastomosis (Xiao procedure) for bladder control in children with myelomeningocele and lipomyelomeningocele: results of a prospective, randomized, double-blind study.

OBJECTIVE Xiao et al. and other investigators have studied an intradural somatic-to-autonomic (e.g., L-5 to S3-4) nerve transfer as a method to create a reflex arc to allow bladder emptying in response to cutaneous stimulation (the Xiao procedure). In previous clinical studies of patients with spinal dysraphism who underwent the Xiao procedure, high success rates (70%-85%) were reported for the establishment of a "skin-CNS-bladder" reflex arc that allows spontaneous, controlled voiding in children with neurogenic bladder dysfunction. However, many of these studies did not use blinded observers, did not have control groups, and/or featured only limited follow-up durations. METHODS A randomized, prospective, double-blind trial was initiated in March 2009, enrolling children with myelomeningocele (MM), lipomyelomeningocele (LMM), and neurogenic bladder dysfunction who were scheduled for spinal cord detethering (DT) for the usual indications. At the time of DT, patients were randomized between 2 arms of the study: half of the patients underwent a standard spinal cord DT procedure alone (DT group) and half underwent DT as well as the Xiao procedure (DT+X group). Patients, families, and study investigators, all of whom were blinded to the surgical details, analyzed the patients' strength, sensory function, mobility, voiding, and urodynamic bladder function before surgery and at regular intervals during the 3-year follow-up. RESULTS Twenty patients were enrolled in the study: 10 underwent only DT and the other 10 underwent DT+X. The addition of the Xiao procedure to spinal cord DT resulted in longer operative times (p = 0.024) and a greater chance of wound infection (p = 0.03). Patients in both treatment arms could intermittently void or dribble small amounts of urine (< 20% total bladder capacity) in response to scratching in dermatomes T-9 through S-2 using a standardized protocol, but the voiding was not reproducible and the volume voided was not clinically useful in any patient. Voiding in response to scratching was not more frequent in patients who underwent DT+X compared with those who underwent only DT. Bladder contractions in response to scratching occurred in both treatment arms at various intervals after surgery, but they were not more reproducible or more frequent in the patients who underwent the Xiao procedure than in the patients who did not. No patient in either treatment arm was continent of urine before, during, or after the study. CONCLUSIONS Patients with MM and LMM who underwent the Xiao procedure during spinal cord DT were no more likely to be able to void, to control their urination, to achieve continence, or to have a demonstrable urodynamic bladder contraction in response to cutaneous stimulation than patients who underwent only spinal cord DT. This study, in the context of disappointing results reported in other recent studies of the Xiao procedure, raises doubts about the clinical applicability of this procedure in humans until further basic science research is performed.

Attempted bladder reinnervation and creation of a scratch reflex for bladder emptying through a somatic-to-autonomic intradural anastomosis.

An intradural somatic-to-autonomic anastomosis, or Xiao procedure, has been described to create a "skin-CNS-bladder" reflex that improves bladder and bowel function in patients with neurogenic bladder and bowel dysfunction. The authors present their experience with a 10-year-old boy with chronic neurogenic bladder and bowel dysfunction related to spinal cord injury who underwent the Xiao procedure. After undergoing a left L-5 ventral root to left S2-3 intradural anastomosis, the patient reported that his bladder and bowel dysfunction improved between 6 and 12 months. Two years after the procedure, however, he reported that there was no change in his bladder or bowel dysfunction as compared with his condition prior to the procedure. Frequent, systematic multidisciplinary evaluations produced conflicting data. Electrophysiological and histological evaluation of the previously performed anastomosis during surgical reexploration 3 years after the Xiao procedure revealed that the anastomosis was in anatomical continuity but neuroma formation had prevented reinnervation. Nerve action potentials were not demonstrable across the anastomosis, and stimulation of the nerve above and below the anastomosis created no bladder or perineal contractions. This is the first clinical report on the outcome of the Xiao procedure in a child with spinal cord injury outside of China. It is impossible to draw broad conclusions about the efficacy of the procedure based on a single patient with no demonstrable benefit. However, future studies should carefully interpret transient improvements in bladder function, urodynamic findings, and the patient's ability to void in response to scratching after the Xiao procedure. The authors' experience with the featured patient, in whom reinnervation could not be demonstrated, suggests that such changes could be related to factors other than the establishment of a skin-CNS-bladder reflex as a result of a somatic-to-autonomic anastomosis.

Treatment of occult reflux lowers the incidence rate of pediatric febrile urinary tract infection.

OBJECTIVES: To examine whether vesicourethral reflux diagnosed by positioned instillation of contrast (PIC-VUR) shows clinical importance by comparing the incidence rates of febrile urinary tract infection (FUTI) before and after treatment of PIC-VUR. METHODS: Beginning in 2001 we used a multi-institutional registry to prospectively enroll consecutive pediatric patients with a history of FUTI without VUR according to voiding cystourethrogram (VCUG) and yet who show PIC-VUR. Treatment of PIC-VUR was with prophylactic antimicrobials or antireflux surgery. The post-treatment occurrence of FUTI was tracked. RESULTS: A total of 14 centers enrolled 118 patients (mean age, 7.2 years; range, 0.5 to 20 years). Parents self-selected the treatment of PIC-VUR as endoscopic injection (104), ureteral reimplantation (3), or antimicrobial prophylaxis (11). Study intervals surveying for FUTI before PIC (mean, 12 months; range, 1 to 17 years) and after PIC treatment (mean, 11 months; range, 0 to 3 years) were not significantly different. Overall the incidence rate for FUTI decreased significantly from 0.16 per patient per month before PIC-VUR treatment to 0.008 per patient per month after treatment (rate ratio 20; 95% confidence interval 11 to 36). The post-treatment rate of FUTI in patients treated with antibiotics versus surgery was not significantly different (rate ratio 2.5; 95% confidence interval 0.33 to 27). CONCLUSIONS: The diagnosis of PIC-VUR is clinically important because children treated for PIC-VUR with either antimicrobial prophylaxis or surgery show a significant reduction in the incidence rate of FUTI. This is the basis for a current prospective study randomizing patients with PIC-VUR to treatment or observation.