Monday, 1 August 2011

BoTox in the Bladder reduces Incontinence

New Trial



Background: Neurogenic detrusor overactivity in the bladder frequently results in urinary incontinence that impairs quality of life.

Objective:To assess the effects of onabotulinumtoxinA (BOTOX(®), Allergan, Inc.) on urinary incontinence in people with detrusor bladder problems.

Trial: This multicentre, randomised, double-blind, placebo-controlled study enrolled patients with multiple sclerosis (number of people n=154) or spinal cord injury (n=121) with detrusor bladder problems of more than 14 incontience episodes a week. Patients received 30 intradetrusor injections of onabotulinumtoxinA 200 Units (n=92), 300 Units (n=91), or placebo (n=92),

Results: OnabotulinumtoxinA benefit was observed by the first post-treatment study visit at week 2. There was reduced urinary incontinence by week 6. Improvements in bladder capacity and Incontinence Quality of Life score were both significantly greater with both onabotulinumtoxinA doses than with placebo. MSers did not request retreatment for 42 weeks compared to 13 weeks with placebo. Adverse events were urinary tract infections and urinary retention, which were dose-related in patients not using clean intermittent catheterisation.

Conclusions: OnabotulinumtoxinA significantly reduced urinary incontinence and improved quality of Life MSers and people with spinal cord injury with detrusor muscle over activity. Both Doses were well tolerated (http://www.clinicaltrials.gov; NCT00461292).

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