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Botulinum Toxin Type A Is Effective in Neurogenic Urinary Incontinence

By Jill Stein

SAN ANTONIO, TX -- May 30, 2005 -- Treatment with a single dose of botulinum toxin type A (Botox) is a rapid, effective, and safe treatment for urinary incontinence secondary to neurogenic detrusor overactivity, new data suggest.

The results, which were released on May 24^th at the American Urological Association (AUA) Annual Meeting, are from a multicenter trial that included 59 patients with neurogenic urinary incontinence who required regular clean intermittent self-catheterization and who had failed oral anticholinergic therapy.

"Urinary incontinence occurring between catheterizations is common in neurogenic patients requiring clean intermittent self-catheterization to drain the bladder," said principal investigator Brigitte Schurch, MD, chairman of the neurology division at the Spinal Cord Injury Center at the University Hospital Balgrist in Zurich, Switzerland, who presented the data.

"While oral anticholinergics are the most commonly prescribed treatment for urinary incontinence, poor tolerability or a lack of efficacy can interfere with their usefulness.
Botulinum toxin type A may be an attractive option for the management of urinary incontinence in patients who are dissatisfied or poorly managed on oral therapies."

After a 2-week screening period, subjects were randomized to treatment with a single masked injection of botulinum toxin type A (200 or 300 U) or placebo.

Cystoscopic guidance was used to deliver the treatment as 30 1 mL injections, administered evenly over the detrusor muscle, avoiding the base and trigone.

The study found that significant decreases in the number of incontinence episodes occurred in both botulinum toxin Type A groups compared with baseline (P less than or equal to .05) but not in the placebo group. The mean decreases ranged from 32% to 54% in the 200 U and 42% to 58% in the 300 U groups. The effects were apparent by the first 2-week assessment and were maintained throughout the 24-week study period.

Twenty-nine patients experienced at least 1 week with no incontinence episodes at all; 83% of these patients were in the botulinum toxin type A groups.

Dramatic improvements in key urodynamic parameters were also observed. For example, significant increases (P less than or equal to .05) in mean maximum cystometric capacity values were seen along with significant decreases (P less than or equal to .05) in maximum detrusor pressure during bladder contraction values. Such changes were not seen with placebo.

There was also a dramatic improvement in quality of life as assessed using the Incontinence Quality of Life (I-QoL) questionnaire throughout the study compared with placebo (P less than or equal to .002). "This reflects the positive effects of botulinum toxin type A on urinary incontinence signs and symptoms," Dr. Schurch said. Increases in I-QoL scores ranged from 18 to 28.3 (a 38% to 60% increase from baseline) and 24.6 to 32.7 (a 58% to 77% increase from baseline) in the botulinum toxin type A 200 U and 300 U groups, respectively.

Botulinum toxin type A treatment was safe and well tolerated. There were no drug-related adverse events reported specific to botulinum toxin type A, and no patient who had the treatment withdrew from the study because of an adverse event.

Overactive bladder is the most common cause of urinary incontinence in adults and is estimated to affect between 13 and 33 million people in the US alone. Overactive bladder with urinary incontinence affects about 12 million Americans.

Neurogenic overactive bladder affects about 50% of patients with multiple sclerosis, 40% of acute stroke patients, 10% to 15% of patients 1 year poststroke, and is common in patients who have complete spinal cord injury.

The study was sponsored by Allergan Ltd.


[Presentation title: Botulinum Toxin A in Neurogenic Bladder: Are There Any Patient Predictors of Response? Abstract 1125]

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