OBJECTIVES: To evaluate and compare the efficacy of botulinum toxin intravesical injections with and without injections in external urethral sphincter in treating bladder hyper-reflexia in children suffering from myelomeningocele. METHODS: A total of 60 patients with bladder hyper-reflexia due to myelomeningocele were randomly allocated to treatment groups A and B and were followed up for 6 months. Under cystoscopic guidance, 10 IU/kg of botulinum toxin A was injected into the detrusor muscle, sparing the trigone and ureteral orifices in group A. Group B received 8 IU/kg of toxin via the same method compared with group A and 2 IU/kg of toxin through 4 injections in external urethral sphincter. Conventional urodynamics, daily incontinence score, constipation, and creatinine level were evaluated at baseline, 3 months, and 6 months after intervention. Vesicoureteral reflux was also assessed before and after 3 months of injections. RESULTS: All patients showed significant improvement in bladder capacity (P <.01), maximal detrusor pressure (P <.01), and detrusor-sphincter dyssynergia (P <.01) after 3 and 6 months of receiving injections. Significant improvement in postvoiding residual volume was observed only among patients of group B (P <.05). Both methods resulted in a significant reduction in daily incontinence grade, constipation, and vesicoureteral reflux (P <.05), but comparison between the study groups showed better outcomes for group B in relation to incontinency, constipation, vesicoureteral reflux, and creatinine level. CONCLUSIONS:Botulinum toxin type A injections in both sphincter and detrusor seems to have extra benefits such as decreasing postvoiding residual volume and more symptom diminution compared with intradetrusal injections alone. Copyright 2010 Elsevier Inc. All rights reserved.
RCT Entities:
OBJECTIVES: To evaluate and compare the efficacy of botulinum toxin intravesical injections with and without injections in external urethral sphincter in treating bladder hyper-reflexia in children suffering from myelomeningocele. METHODS: A total of 60 patients with bladder hyper-reflexia due to myelomeningocele were randomly allocated to treatment groups A and B and were followed up for 6 months. Under cystoscopic guidance, 10 IU/kg of botulinum toxin A was injected into the detrusor muscle, sparing the trigone and ureteral orifices in group A. Group B received 8 IU/kg of toxin via the same method compared with group A and 2 IU/kg of toxin through 4 injections in external urethral sphincter. Conventional urodynamics, daily incontinence score, constipation, and creatinine level were evaluated at baseline, 3 months, and 6 months after intervention. Vesicoureteral reflux was also assessed before and after 3 months of injections. RESULTS: All patients showed significant improvement in bladder capacity (P <.01), maximal detrusor pressure (P <.01), and detrusor-sphincter dyssynergia (P <.01) after 3 and 6 months of receiving injections. Significant improvement in postvoiding residual volume was observed only among patients of group B (P <.05). Both methods resulted in a significant reduction in daily incontinence grade, constipation, and vesicoureteral reflux (P <.05), but comparison between the study groups showed better outcomes for group B in relation to incontinency, constipation, vesicoureteral reflux, and creatinine level. CONCLUSIONS: Botulinum toxin type A injections in both sphincter and detrusor seems to have extra benefits such as decreasing postvoiding residual volume and more symptom diminution compared with intradetrusal injections alone. Copyright 2010 Elsevier Inc. All rights reserved.