PURPOSE: We report a prospective randomized controlled study to evaluate the possible benefits of sacral neuromodulation (SNM) for the management of neurogenic bladder dysfunction in children. MATERIALS AND METHODS: We included in the study subjects between the ages of 5 and 21 years presenting with urinary incontinence due to neurogenic bladder. Before study inclusion all previous treatment was discontinued. Patients were randomly divided into the control group treated conventionally and the implant group treated with SNM. Treatment outcome was compared every 3 months for a minimum of 12 months based on clinical examination, voiding diary and urodynamic evaluation. RESULTS: A total of 26 boys and 16 girls with a mean age of 11.9 years were enrolled in this study. There were 21 patients in each group. The main underlying etiology was spina bifida. The 2 groups were comparable with regard to sex, age and urodynamic variables. Total disappearance of urinary leakage was observed in 1 patient who underwent implantation but he still required intermittent catheterization. Comparison of urodynamic variables disclosed no significant statistical difference except with regard to functional bladder capacity which was better in the control group and the leak point pressure which was better in the implant group (p <0.05). Evaluation of interindividual variations in the implant group revealed significant improvement in compliance and functional bladder capacity at 6 and 9 months but not at 12 months. Nine patients in the implant group reported improvement in intestinal transit, 5 total disappearance of urinary infection and 6 persistent sensation of a full bladder. No patient in the control group reported any improvement. Revision surgery was required in 3 cases due to lead migration, faulty connection and wound infection. CONCLUSIONS:SNM is a promising new therapeutic modality. Implant placement is minimally invasive, nondestructive and reversible. Use in children with neurogenic bladder has not been previously reported. Although some improvement was noted in patients treated with SNM, the difference with the control group was not significant. A larger multicenter study is warranted to evaluate SNM.
RCT Entities:
PURPOSE: We report a prospective randomized controlled study to evaluate the possible benefits of sacral neuromodulation (SNM) for the management of neurogenic bladder dysfunction in children. MATERIALS AND METHODS: We included in the study subjects between the ages of 5 and 21 years presenting with urinary incontinence due to neurogenic bladder. Before study inclusion all previous treatment was discontinued. Patients were randomly divided into the control group treated conventionally and the implant group treated with SNM. Treatment outcome was compared every 3 months for a minimum of 12 months based on clinical examination, voiding diary and urodynamic evaluation. RESULTS: A total of 26 boys and 16 girls with a mean age of 11.9 years were enrolled in this study. There were 21 patients in each group. The main underlying etiology was spina bifida. The 2 groups were comparable with regard to sex, age and urodynamic variables. Total disappearance of urinary leakage was observed in 1 patient who underwent implantation but he still required intermittent catheterization. Comparison of urodynamic variables disclosed no significant statistical difference except with regard to functional bladder capacity which was better in the control group and the leak point pressure which was better in the implant group (p <0.05). Evaluation of interindividual variations in the implant group revealed significant improvement in compliance and functional bladder capacity at 6 and 9 months but not at 12 months. Nine patients in the implant group reported improvement in intestinal transit, 5 total disappearance of urinary infection and 6 persistent sensation of a full bladder. No patient in the control group reported any improvement. Revision surgery was required in 3 cases due to lead migration, faulty connection and wound infection. CONCLUSIONS:SNM is a promising new therapeutic modality. Implant placement is minimally invasive, nondestructive and reversible. Use in children with neurogenic bladder has not been previously reported. Although some improvement was noted in patients treated with SNM, the difference with the control group was not significant. A larger multicenter study is warranted to evaluate SNM.
Authors: Arun K Sharma; Matthew I Bury; Natalie J Fuller; Andrew J Marks; David M Kollhoff; Manoj V Rao; Partha V Hota; Derek J Matoka; Seby L Edassery; Hatim Thaker; John F Sarwark; Joseph A Janicki; Guillermo A Ameer; Earl Y Cheng Journal: Proc Natl Acad Sci U S A Date: 2013-02-19 Impact factor: 11.205