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.
Further information: Allergan