PURPOSE: We investigated whether botulinum-A toxin is better used alone or in conjunction with oxybutynin chloride in the management of refractory neuropathic bladder. MATERIALS AND METHODS:Between March 2004 and February 2006 a total of 23 children (mean age 5.6 +/- 2.5 years) with neuropathic bladder refractory to medical treatment underwent cystoscopic treatment with botulinum-A toxin. Patients were randomly assigned postoperatively using closed envelopes (blind randomization) into 2 equal groups. Group 1 (12 patients) continued to receive anticholinergics while in group 2 (11 patients) anticholinergics were discontinued. Clinical and urodynamic evaluations were performed before injection, and at 1 and 6-month intervals. Patients were then followed every 6 months with urodynamic study. The outcomes were compared between groups with a paired t test (2-tailed) and a significant p value <0.025. RESULTS:Maximum bladder capacity increased from 96 +/- 67 (range 15 to 277) to 163 +/- 96 ml (range 50 to 500, p <0.001) and 142 +/- 65 ml (range 21 to 250, p <0.006) at 1 and 6 months, respectively. Maximal detrusor pressure decreased from 76 +/- 36 (range 36 to 209) to 50 +/- 22 cm H2O (range 20 to 100, p <0.001) and 51 +/- 21 cm H2O (range 18 to 104, p <0.001) at 1 and 6 months, respectively. From a clinical point of view 9 of the 16 incontinent patients (56.2%) showed complete continence after treatment while 4 (25%) reported mild to moderate improvement and 3 (18.8%) showed no improvement. None of the patients had side effects related to the procedure or the material used. CONCLUSIONS: We confirmed the beneficial use of botulinum-A toxin for the treatment of refractory neuropathic bladder and have not yet found any augmentative effect of oxybutynin chloride in this study group. Accordingly we can use such a modality as sole treatment for noncompliant neuropathic bladder.
RCT Entities:
PURPOSE: We investigated whether botulinum-A toxin is better used alone or in conjunction with oxybutynin chloride in the management of refractory neuropathic bladder. MATERIALS AND METHODS: Between March 2004 and February 2006 a total of 23 children (mean age 5.6 +/- 2.5 years) with neuropathic bladder refractory to medical treatment underwent cystoscopic treatment with botulinum-A toxin. Patients were randomly assigned postoperatively using closed envelopes (blind randomization) into 2 equal groups. Group 1 (12 patients) continued to receive anticholinergics while in group 2 (11 patients) anticholinergics were discontinued. Clinical and urodynamic evaluations were performed before injection, and at 1 and 6-month intervals. Patients were then followed every 6 months with urodynamic study. The outcomes were compared between groups with a paired t test (2-tailed) and a significant p value <0.025. RESULTS: Maximum bladder capacity increased from 96 +/- 67 (range 15 to 277) to 163 +/- 96 ml (range 50 to 500, p <0.001) and 142 +/- 65 ml (range 21 to 250, p <0.006) at 1 and 6 months, respectively. Maximal detrusor pressure decreased from 76 +/- 36 (range 36 to 209) to 50 +/- 22 cm H2O (range 20 to 100, p <0.001) and 51 +/- 21 cm H2O (range 18 to 104, p <0.001) at 1 and 6 months, respectively. From a clinical point of view 9 of the 16 incontinentpatients (56.2%) showed complete continence after treatment while 4 (25%) reported mild to moderate improvement and 3 (18.8%) showed no improvement. None of the patients had side effects related to the procedure or the material used. CONCLUSIONS: We confirmed the beneficial use of botulinum-A toxin for the treatment of refractory neuropathic bladder and have not yet found any augmentative effect of oxybutynin chloride in this study group. Accordingly we can use such a modality as sole treatment for noncompliant neuropathic bladder.