All these parameters improved significantly in the BoNTA arm. However, this was a single-center study and the patients were followed up for 12 weeks only.[20] In a recent prospective, double-blind, multicenter, 36-week follow-up study (with an extension of 36 weeks by selleck Pazopanib giving open-label injection of BoNTA after completion of the double-blind period of first 36 weeks), 57 patients of 18�C75 years of age with refractory neurogenic DO secondary to spinal cord injury or multiple sclerosis and urinary incontinence were randomized to receive either 300 units of BoNTA (n=28) or placebo (n=29) via cystoscopic injection into the detrusor muscle. As compared to placebo, the mean daily frequency of urinary incontinence episodes was significantly lower for the BoNTA-treated group.
There was also significant improvement in urodynamic and QoL parameters for the treatment group as compared to the placebo group. It was concluded by the authors that in adults with antimuscarinic-refractory neurogenic DO or multiple sclerosis, BoNTA is well tolerated and provides clinically beneficial improvement for up to 9 months.[21] This multicenter study clearly established the long-term efficacy of BoNTA in refractory DO and OAB. Another study has reported recently that urodynamic improvement can be maintained for at least 6 months with 100 units of intradetrusor injections of BoNTA in patients with refractory OAB.[22] Though no serious adverse effect has been reported with the ��off-label�� use of BoNTA in patients with refractory OAB, there are reports of botulinum toxin spreading from the area of injection to other areas of the body and causing symptoms similar to those of botulism in children with cerebral palsy being treated with BoNTA for muscle spasticity.
Such symptoms include unexpected loss of strength or Brefeldin_A muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision, and drooping eyelids. In view of such reports the FDA has directed safety label changes, including a boxed warning, for all botulinum toxin products.