CLINICAL TRIAL
JOURNAL ARTICLE
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Intravesical electromotive botulinum toxin type A administration--part II: Clinical application.

Urology 2011 Februrary
OBJECTIVES: To assess the effect of electromotive botulinum toxin type A administration on urodynamic variables, urinary/fecal incontinence, and vesicoureteral reflux (VUR) due to refractory neurogenic detrusor overactivity in children with myelomeningocele.

METHODS: A total of 15 children (mean age 7.8 years) were included. Using a specially designed catheter, 10 IU/kg of electromotive botulinum toxin type A was inserted into the distended bladder. While connected to the indwelling catheter and 2 dispersive pads, a pulsed current generator delivered 10 mA for 15 minutes. The urodynamic parameters, including reflex volume, maximal bladder capacity, maximal detrusor pressure, and end-fill pressure, and the urinary/fecal incontinence status and VUR grade were evaluated before and at 1, 4, and 9 months after treatment.

RESULTS: The mean reflex volume and maximal bladder capacity had increased considerably (99 ± 35 mL versus 216 ± 35 mL and 121 ± 39 mL versus 262 ± 41 mL, respectively; P < .001). In contrast, the mean maximal detrusor pressure and end-fill pressure had significantly decreased (75 ± 16 cm H(2)O versus 39 ± 10 cm H(2)O and 22 ± 7 cm H(2)O versus 13 ± 2 cm H(2)O) after treatment. The difference was statistically significant (P < .001). Urinary incontinence improved in 12 patients (80%). The VUR grade substantially decreased in 7 of the 12 children (mean VUR grade 2.25 ± 1.3 versus 1.37 ± 0.7; P = .001), and none of the children required surgical intervention. Fecal incontinence was alleviated in 10 (83.3%) of the 12 children. Skin erythema and burning sensation were observed in 6 children.

CONCLUSIONS: The results of our study have shown that electromotive botulinum toxin type A administration is a feasible and safe method with no need for anesthesia. This novel delivery system resulted in considerable improvement in the urodynamic parameters, urinary/fecal incontinence, and VUR in patients with refractory neurogenic detrusor overactivity.

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