Botox approved as overactive bladder treatment

Botox (botulinum toxin type A) can now be used to treat overactive bladder in patients inadequately managed by anticholinergics.

Botox is the only brand of botulinum toxin that is licensed for the treatment of overactive bladder

Already indicated for urinary incontinence due to neurogenic detrusor overactivity in patients with subcervical spinal cord injury or multiple sclerosis, Botox is now also licensed as a treatment for symptoms of urinary frequency, urgency and incontinence caused by overactive bladder. 

Fewer incontinence episodes

Two double-blind, placebo-controlled, 24-week phase III clinical studies examined the effect of Botox in this setting. Investigators randomised a total of 1,105 patients (mean age 60 years), whose symptoms had not been adequately managed with one or more anticholinergics, to receive either 100 Units of Botox (n=557) or placebo (n=548) by injection into the bladder wall. Participants were required to discontinue any anticholinergics before undergoing study treatment.

After 12 weeks, the mean number of  daily urinary incontinence episodes (co-primary endpoint) had decreased by 2.74 in patients who underwent Botox treatment and by 0.95 in those who received placebo (p<0.001). Overall, 61.8% of patients in the Botox group reported a positive response on the treatment benefit scale (second co-primary endpoint), compared with 28.0% of those in the placebo group (p<0.001). 

Botox is recommended by NICE as an option to treat overactive bladder caused by detrusor overactivity that has not responded to conservative management.

View Botox drug record

Further information: Allergan

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