Effect of Prenatal Repair of Myelomeningocele on Urological Outcomes at School Age
John Brock, III, MD1, John Thomas, MD1, Stephen Zderic, MD2, Larry Baskin, MD3.
1Vanderbilt University, Nashville, TN, USA, 2Childrens Hospital of Philadelphia, Philadelphia, PA, USA, 3University of California, San Francisco, San Francisco, CA, USA.
BACKGROUND: The Management of Myelomeningocele Study (MOMS) was a multi-center randomized trial of prenatal versus postnatal surgery for repair of myelomeningocele. The trial found no difference in the need for clean intermittent catheterization (CIC) by 30 months of age between the surgery groups, but the potential for future urologic benefits in these children remained unclear. This follow-up study reports longer term urological outcomes in patients enrolled in MOMS. METHODS: Women who had participated in the original trial were contacted to determine if they were interested in participating in a follow-up study, when the child was at least 6 years old. The families were offered a single comprehensive study visit. Children who came to the clinic underwent urologic and radiologic procedures designed to provide objective evidence of current bladder functioning and the later effects of neurogenic bladder on the nephro-urologic system. The primary outcome for the urology component of the follow-up study was a composite of urologic function defined as any of the following: need for CIC at least three times per day, vesicostomy, urethral dilatation or augmentation cystoplasty. Urologic and surgical history since the original study were captured via parental report. RESULTS: A total of 156 children (78 pre- and 78 post-natal) had urologic examinations and were included in the analysis. Mean age at follow-up in both groups was 7.4 years. Of the children in the prenatal surgery group, 61.5% compared with 87.2% of the children in the postnatal group required CIC (Relative Risk (RR) = 0.71, 95% confidence interval (CI) 0.58 - 0.86; p< 0.001). All children who met the primary outcome were on CIC. Voiding status (on CIC, in diapers not on CIC, and voiding volitionally) was significantly different between the treatment groups (chi-squared = 14.8, p =0.0006). Twenty-four percent of children who had prenatal repair were volitionally voiding compared with only 4.2% of those in the postnatal group (RR 5.8, 95% CI 1.8 - 18.7). Surgical procedures for primary outcome such as augmentation cystoplasty, vesicostomy, and urethral dilation did not differ between the two groups. Likewise, there were no statistical differences in videourodynamic data or findings on renal/bladder ultrasound. CONCLUSIONS: Prenatal repair of myelomeningocele resulted in less need for CIC on longer term follow-up, when children were 6-10 years of age. The mechanism for this is unclear, as the videourodynamic findings and need for secondary surgery did not differ between the groups. In addition, children who underwent prenatal repair were almost six times more likely to void volitionally as compared with the post-natal repair group. Further follow-up of these children as they enter adolescence will be valuable. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00060606.)
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