John W Brock1, Michael C Carr2, N Scott Adzick3, Pamela K Burrows4, John C Thomas5, Elizabeth A Thom4, Lori J Howell3, Jody A Farrell6, Mary E Dabrowiak7, Diana L Farmer6, Earl Y Cheng8, Bradley P Kropp9, Anthony A Caldamone10, Dorothy I Bulas11, Susan Tolivaisa12, Laurence S Baskin13. 1. Departments of Urology, and john.brock@vanderbilt.edu. 2. Division of Pediatric Urology, and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; 3. Center for Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; 4. The Biostatistics Center, George Washington University, Washington, District of Columbia; 5. Departments of Urology, and. 6. Department of Surgery, Benioff Children's Hospital, and. 7. Pediatric Surgery/Fetal Center, Vanderbilt University Medical Center, Nashville, Tennessee; 8. Lurie Children's Hospital and Northwestern University, Chicago, Illinois; 9. Department of Urology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma; 10. Division of Urology, Warren Alpert Medical School of Brown University, Providence, Rhode Island; 11. Department of Diagnostic Imaging and Radiology, Children's National Medical Center, Washington, District of Columbia; and. 12. Pregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland. 13. Department of Urology, University of California, San Francisco, San Francisco, California;
Abstract
BACKGROUND: A substudy of the Management of Myelomeningocele Study evaluating urological outcomes was conducted. METHODS:Pregnant women diagnosed with fetal myelomeningocele were randomly assigned to either prenatal or standard postnatal surgical repair. The substudy included patients randomly assigned after April 18, 2005. The primary outcome was defined in their children as death or the need for clean intermittent catheterization (CIC) by 30 months of age characterized by prespecified criteria. Secondary outcomes included bladder and kidney abnormalities observed by urodynamics and renal/bladder ultrasound at 12 and 30 months, which were analyzed as repeated measures. RESULTS: Of the 115 women enrolled in the substudy, the primary outcome occurred in 52% of children in the prenatal surgery group and 66% in the postnatal surgery group (relative risk [RR]: 0.78; 95% confidence interval [CI]: 0.57-1.07). Actual rates of CIC use were 38% and 51% in the prenatal and postnatal surgery groups, respectively (RR: 0.74; 95% CI: 0.48-1.12). Prenatal surgery resulted in less trabeculation (RR: 0.39; 95% CI: 0.19-0.79) and fewer cases of open bladder neck on urodynamics (RR: 0.61; 95% CI: 0.40-0.92) after adjustment by child's gender and lesion level. The difference in trabeculation was confirmed by ultrasound. CONCLUSIONS: Prenatal surgery did not significantly reduce the need for CIC by 30 months of age but was associated with less bladder trabeculation and open bladder neck. The implications of these findings are unclear now, but support the need for long-term urologic follow-up of patients with myelomeningocele regardless of type of surgical repair.
RCT Entities:
BACKGROUND: A substudy of the Management of Myelomeningocele Study evaluating urological outcomes was conducted. METHODS: Pregnant women diagnosed with fetal myelomeningocele were randomly assigned to either prenatal or standard postnatal surgical repair. The substudy included patients randomly assigned after April 18, 2005. The primary outcome was defined in their children as death or the need for clean intermittent catheterization (CIC) by 30 months of age characterized by prespecified criteria. Secondary outcomes included bladder and kidney abnormalities observed by urodynamics and renal/bladder ultrasound at 12 and 30 months, which were analyzed as repeated measures. RESULTS: Of the 115 women enrolled in the substudy, the primary outcome occurred in 52% of children in the prenatal surgery group and 66% in the postnatal surgery group (relative risk [RR]: 0.78; 95% confidence interval [CI]: 0.57-1.07). Actual rates of CIC use were 38% and 51% in the prenatal and postnatal surgery groups, respectively (RR: 0.74; 95% CI: 0.48-1.12). Prenatal surgery resulted in less trabeculation (RR: 0.39; 95% CI: 0.19-0.79) and fewer cases of open bladder neck on urodynamics (RR: 0.61; 95% CI: 0.40-0.92) after adjustment by child's gender and lesion level. The difference in trabeculation was confirmed by ultrasound. CONCLUSIONS: Prenatal surgery did not significantly reduce the need for CIC by 30 months of age but was associated with less bladder trabeculation and open bladder neck. The implications of these findings are unclear now, but support the need for long-term urologic follow-up of patients with myelomeningocele regardless of type of surgical repair.
Authors: Douglass B Clayton; Stacy T Tanaka; Lisa Trusler; John C Thomas; John C Pope; Mark C Adams; John W Brock Journal: J Urol Date: 2011-10 Impact factor: 7.450
Authors: N Scott Adzick; Elizabeth A Thom; Catherine Y Spong; John W Brock; Pamela K Burrows; Mark P Johnson; Lori J Howell; Jody A Farrell; Mary E Dabrowiak; Leslie N Sutton; Nalin Gupta; Noel B Tulipan; Mary E D'Alton; Diana L Farmer Journal: N Engl J Med Date: 2011-02-09 Impact factor: 91.245
Authors: S B Bauer; M Hallett; S Khoshbin; R L Lebowitz; K R Winston; S Gibson; A H Colodny; A B Retik Journal: JAMA Date: 1984-08-03 Impact factor: 56.272
Authors: Jason P Van Batavia; Dana A Weiss; Christopher J Long; Julian Madison; Gus McCarthy; Natalie Plachter; Stephen A Zderic Journal: J Pediatr Rehabil Med Date: 2018
Authors: Mano Shanmuganathan; Deborah A Sival; Kelly-Ann Eastwood; Katie Morris; Jacqueline Cartmill; Axel Heep; Janusz Bohosiewicz; Agnieszka Pastuszka; Alyson Hunter; Amanda Ali; Roy McConnell; Darach Crimmins; Fergal Malone; Carolyn Bailie; Jan Deprest; Cathy McKillop; Zarko Alfirevic; Fionnuala McAuliffe; Stephen Ong Journal: Ir J Med Sci Date: 2017-11-03 Impact factor: 1.568
Authors: Sandra K Kabagambe; Y Julia Chen; Melissa A Vanover; Payam Saadai; Diana L Farmer Journal: Childs Nerv Syst Date: 2017-05-11 Impact factor: 1.475